The Prescription Only Medicines (Human Use) Order 1997

Statutory Instruments

1997 No. 1830

MEDICINES

The Prescription Only Medicines (Human Use) Order 1997

Made

25th July 1997

Laid before Parliament

28th July 1997

Coming into force

18th August 1997

The Secretary of State concerned with health in England, the Secretaries of State concerned with health and with agriculture in Wales and in Scotland respectively, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred on them by sections 58(1), (4) and (5), 59(1) and 129(4) of the Medicines Act 1968(1) or, as the case may be, those conferred by the said provisions and now vested in them(2), and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by this Order, pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Medicines Commission pursuant to sections 58(6) and 129(7) of that Act, hereby make the following Order:

Citation, commencement and interpretation

1.—(1) This Order may be cited as the Prescription Only Medicines (Human Use) Order 1997 and shall come into force on 18th August 1997.

(2) In this Order, unless the context otherwise requires–

“the Act” means the Medicines Act 1968;

[F1 “additional supply optometrist” means a person who is registered as an optometrist, and against whose name particulars of the additional supply speciality have been entered in the relevant register;]

“aerosol” means a product which is dispersed from its container by a propellent gas or liquid;

[F2 “clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—

(a)

the patient to whom the plan relates,

(b)

the doctor or dentist who is a party to the plan, and

(c)

any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;]

[F3 “clinical trial” has the meaning given by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2003;]

F4 ...

[F5 “Common Services Agency” means the Common Services Agency for the Scottish Health Service established under section 10 of the National Health Service (Scotland) Act 1978;]

[F5 “Community marketing authorization” means a marketing authorization granted by the European Community under Council Regulation (EEC) No. 2309/93 [F6 or Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency];]

[F7 “community practitioner nurse prescriber” means a person—

(a)

who is a registered nurse or a registered midwife, and

(b)

against whose name is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Nurse Prescribers' Formulary for Community Practitioners in the current edition of the British National Formulary;]

“controlled drug” has the meaning assigned to it by section 2 of the Misuse of Drugs Act 1971(3);

“cyanogenetic substances” means preparations which–

(a)

are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17, or

(b)

contain more than 0.1 per cent by weight of any substance having the formula either α-Cyanobenzyl-6-O-β-d-glucopyranosyl-β-d-glucopyranoside or α-Cyanobenzyl-β-d-glucopy ranosiduronic acid;

F8 ...

“dosage unit” means–

(a)

where a medicinal product is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article, or

(b)

where a medicinal product is not in any such form, the unit of measurement which is used as the unit by reference to which the dose of the medicinal product is measured;

F9 ...

F10 ...

“external use” means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal when a local action only is intended and extensive systemic absorption is unlikely to occur; and references to medicinal products for external use shall be read accordingly except that such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;

F11 ...

[F5 “Health Authority”—

(a)

F12 ...

(b)

in relation to Scotland, means a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and

(c)

in relation to Northern Ireland, means a Health and Social Services Board established under Article 16 of the Health and Personal Social Services (Northern Ireland) Order 1972;]

[F13 “health care” means services for or in connection with the prevention, diagnosis or treatment of disease;]

“health prescription” means a prescription issued by a doctor, dentist [F14 , supplementary prescriber] , [F15 a community practitioner nurse prescriber, a nurse independent prescriber or a pharmacist independent prescriber] under or by virtue of–

(a)

in England and Wales, the National Health Service Act 1977(4),

(b)

in Scotland, the National Health Service (Scotland) Act 1978(5), and

(c)

in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 1972(6);

[F16 “health record” has the meaning given by section 68(2) of the Data Protection Act 1998(6);]

[F5 “homoeopathic certificate of registration” means a certificate of registration for the purposes of the Medicines (Homoeopathic Medicinal Products For Human Use) Regulations 1994;]

[F17 “independent clinic”—

(a)

in relation to England and Wales, has the meaning given by section 2(4) of the Care Standards Act 2000(8), and

(b)

in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act [F18 2001, and];]

(c)

[F19 in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;]

[F17 “independent hospital”—

(a)

in relation to England and Wales, shall be construed in accordance with section 2(2), (3) and (6) of the Care Standards Act 2000, and

(b)

in relation to Scotland, means—

(i)

an independent hospital, or

(ii)

a private psychiatric hospital,

as defined by section 77(1) of the Regulation of Care (Scotland) Act [F20 2001, and]]

(c)

[F21 in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;]

[F17 “independent medical agency”—

(a)

in relation to England and Wales, has the meaning given by section 2(5) of the Care Standards Act 2000, and

(b)

in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act [F22 2001, and]]

(c)

[F23 in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;]

“inhaler” does not include an aerosol;

[F24 “IRME practitioner” means, in relation to a medical exposure, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2000(4);]

[F25 “Local Health Board” has the same meaning as in the National Health Service Act 1977;]

[F5 “marketing authorization” includes a reference both to a United Kingdom marketing authorization and to a Community marketing authorization;]

“master” has the same meaning as in section 313(1) of the Merchant Shipping Act 1995(7);

“maximum daily dose” or “MDD” means the maximum quantity of a substance contained in the amount of a medicinal product which it is recommended should be taken or administered in a period of 24 hours;

“maximum dose” or “MD” means the maximum quantity of a substance contained in the amount of a medicinal product which it is recommended should be taken or administered at any one time;

“maximum strength” means–

(a)

the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;

(b)

the maximum percentage of a substance contained in a medicinal product calculated in any of the following ways–

(i)

weight in weight,

(ii)

weight in volume,

(iii)

volume in weight, or

(iv)

volume in volume,

and if the maximum percentage calculated in those ways differs, the higher or highest such percentage;

[F26 “medical exposure” has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000;]

“medicinal product” includes any article or substance in respect of which section 58 of the Act has effect by virtue of an order made under section 104 of the ActF27 ...

“the Misuse of Drugs Regulations” means, in relation to England, Wales and Scotland, the Misuse of Drugs Regulations 1985(8) and in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1986(9);

[F5 “NHS trust”—

(a)

in relation to England and Wales, has the same meaning as in the National Health Service and Community Care Act 1990;

(b)

in relation to Scotland, has the same meaning as in the National Health Service (Scotland) Act 1978; and

(c)

in relation to Northern Ireland, means a Health and Social Services trust established under article 10 of the Health and Social Services (Northern Ireland) Order 1991;]

[F28 “nurse independent prescriber” means a person—

(a)

who is a registered nurse or a registered midwife, and

(b)

against whose name is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances as a nurse independent prescriber or a nurse independent/supplementary prescriber;]

[F29 “NHS foundation trust” has the same meaning as in section 1(1) of the Health and Social Care (Community Health and Standards) Act 2003;]

[F30 “nursing home” has the meaning given by article 16 [F31 article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003];]

“occupational health scheme” means a scheme in which a person, in the course of a business carried on by him, provides facilities for his employees for the treatment or prevention of disease;

“offshore installation” means an offshore installation within the meaning of the Mineral Workings (Offshore Installations) Act 1971(10) which is within–

(a)

tidal waters and parts of the sea in or adjacent to the United Kingdom up to the seaward limits of territorial waters;

(b)

waters in any area designated under section 1(7) of the Continental Shelf Act 1964(11);

[F32 “operator”—

(a)

in relation to an aircraft, means the person for the time being having management of the aircraft, and

(b)

for the purposes of article 7B, has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000;]

[F33 “optometrist independent prescriber” means a person—

(a)

who is a registered optometrist, and

(b)

against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;]

“parenteral administration” means administration by breach of the skin or mucous membrane;

[F5 “Patient Group Direction” means—

(a)

in connection with the [F34 sale or] supply of a prescription only medicine as referred to in article 12A(2), [F35 12B, 12C, 12D or 12E], a written direction relating to the [F36 sale or supply, and administration,] of a description or class of prescription only medicine; or

(b)

in connection with the administration of a prescription only medicine as referred to in article 12A(2), 12B or 12C, a written direction relating to the administration of a description or class of prescription only medicine,

• and which, in the case of either (a) or (b)—

  (i)

  is signed by a doctor or dentist, and by a pharmacist; and

  (ii)

  relates to [F37 sale or] supply and administration, or to administration, to persons generally (subject to any exclusions which may be set out in the Direction);]

[F38 “pharmacist independent prescriber” means a person—

(a)

who is a pharmacist, and

(b)

against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;]

“prescription only medicine” means a medicinal product of a description or falling within a class specified in article 3 of this Order;

[F5 “Primary Care Trust” has the same meaning as in the National Health Service Act 1977;]

[F39 “prison service” means—

(a)

in relation to England and Wales, a Minister of the Crown exercising functions in relation to prisons (within the meaning of the Prison Act 1952),

(b)

in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 1989), and

(c)

in relation to Northern Ireland, the Northern Ireland Department exercising functions in relation to prisons (within the meaning of the Prison Act (Northern Ireland) 1953);]

[F40 “professional register” means the register maintained by the Nursing and Midwifery Council [F41 under article 5 of] the Nursing and Midwifery Order 2001;]

“prolonged release” in relation to a medicinal product means a formulation of that product which–

(a)

is used to reduce the rate at which the active ingredient in that product is released after administration, and

(b)

is sold or supplied as a prolonged, controlled or sustained release medicinal product;

[F42 “radioactive medicinal product” means a medicinal product which is, which contains or which generates a radioactive substance and which is, contains or generates that substance in order, when administered, to utilize the radiation emitted therefrom;]

[F43 “registered chiropodist” means a person who is registered in Part 2 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;];

[F44 “registered dietitian” means a person who is registered in Part 4 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F45 “registered midwife” means a person registered in the Midwives' Part of the professional register;]

[F46 “registered nurse” means a person registered in the Nurses' Part [F47 or Specialist Community Public Health Nurses' Part] of the professional register;]

[F44 “registered occupational therapist” means a person who is registered in Part 6 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F48 “registered optometrist” means a person whose name is registered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989, or in the register of visiting optometrists from relevant European States maintained under section 8B(1)(a) of that Act;]

[F43 “registered orthoptist” means a person who is registered in Part 7 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;];

[F44 “registered orthotist and prosthetist” means a person who is registered in Part 10 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F43 “registered paramedic” means a person who is registered in Part 8 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F43 “registered physiotherapist” means a person who is registered in Part 9 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F49 “registered provider” means—

(a)

in relation to an independent hospital, an independent clinic or an independent medical agency—

(i)

in relation to England and Wales, the person who is registered under Part II of the Care Standards Act 2000 as the person carrying on the establishment or agency,

(ii)

in relation to Scotland, the person who is registered under Part 1 of the Regulation of Care (Scotland) Act 2001 as the person providing the establishment or agency, and

(iiii)

[F50 in relation to Northern Ireland, the person registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the person carrying on the establishment or agency, and]

(b)

[F51 in relation to a nursing home, the person registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the person carrying on the establishment;]]

[F43 “registered radiographer” means a person who is registered in Part 11 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F44 “registered speech and language therapist” means a person who is registered in Part 12 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F49 “relevant manager” means—

(a)

in relation to an independent hospital, an independent clinic or an independent medical agency—

(i)

in relation to England and Wales—

(aa)

a person who is registered under Part II of the Care Standards Act 2000 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or

(bb)

if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person,

(ii)

in relation to Scotland, a person, other than the registered provider, who was identified as an individual who is to manage the establishment or agency on the application for registration of that establishment or agency under Part 1 of Regulation of Care (Scotland) Act 2001, and

(iii)

[F52 in relation to Northern Ireland—

(aa)

a person who is registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or

(bb)

if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person, and]

(b)

[F53 in relation to a nursing home—

(i)

a person who is registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or

(ii)

if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person;]]

[F49 “relevant register” means—

(a)

in relation to a [F54 registered] nurse [F55 or registered midwife], the professional register, F56 ...

(b)

in relation to a pharmacist, [F57 Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007] or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976; F58 ...

(c)

[F59 in relation to a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

(i)

chiropodists and podiatrists;

(ii)

physiotherapists; or

(iii)

radiographers diagnostic or therapeutic

that register [F60 ; and]

(d)

[F61 in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989;]]

“repeatable prescription” means a prescription which contains a direction that it may be dispensed more than once;

“sell” means sell by retail as defined in section 131 of the Act and “sale” has a corresponding meaning;

“soap” means any compound of a fatty acid with an alkali or amine;

[F5 “Special Health Authority”—

(a)

in relation to England and Wales, has the same meaning as in the National Health Service Act 1977;

(b)

in relation to Scotland, means a Special Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and

(c)

in relation to Northern Ireland, means a Special Health and Social Services Agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990;]

F62 ...

F62 ...

[F63 “Strategic Health Authority” means a Strategic Health Authority established under section 8 of the National Health Service Act 1977;]

[F64 “supplementary prescriber” means—

(a)

a [F65 registered] nurse, F66 ...

(b)

a pharmacist, F67 [F68 ...

(c)

a registered midwife,] F69 ...

(d)

[F70 a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

(i)

chiropodists and podiatrists;

(ii)

physiotherapists; or

(iii)

radiographers diagnostic or therapeutic [F71 or]]

(e)

[F72 a registered optometrist, ]

against whose name is recorded in the relevant register an annotation [F73 or entry] signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber [F74 or, in the case of a nurse or midwife, as a nurse independent/supplementary prescriber]; ]

“supply” means supply in circumstances corresponding to retail sale as defined in section 131 of the Act;

“unit preparation” means a preparation, including a mother tincture, prepared by a process of solution, extraction or trituration with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert diluent, and then used either in this diluted form or, where applicable, by impregnating tablets, granules, powders or other inert substances.

[F5 “United Kingdom marketing authorization” means a marketing authorization granted by the licensing authority under the Medicines For Human Use (Marketing Authorisations Etc.) Regulations 1994 (including a product licence having effect as such an authorization by virtue of Schedule 6 to those Regulations [F75 or an authorization granted by the licensing authority in accordance with Article 126a of Directive 2001/83/EC]).]

(3) For the purposes of this Order, the equivalence of a substance to a reference material shall be determined by calculating the amount of that reference material which is contained in that substance either by weight or, where the amount of the reference material is specified in terms of international units of activity, those units.

(4) In this Order, unless the context otherwise requires, a reference–

(a) to a numbered section is to the section of the Act which bears that number,

(b) to a numbered article or Schedule is to the article of, or Schedule to, this Order which bears that number,

(c) in an article or in a Part of a Schedule to a numbered paragraph is to the paragraph of that article or Part of that Schedule which bears that number, and

(d) in a paragraph to a lettered sub-paragraph is to the sub-paragraph of that paragraph which bears that letter.

(5) In [F76 Schedules 1, 2, 3A and 5]–

(a) entries specified in columns 2 to 5 relate to the substances listed in column 1 against which they appear and where, in relation to a particular substance listed in column 1, an entry in columns 2 to 5 bears a number or letter it relates only to such entries in the other of those columns as bear the same number or letter;

(b) the following abbreviations are used:

• “g” for gram,

• “iu” for international unit of activity,

• “mcg” for microgram,

• “mg” for milligram,

• “ml” for millilitre.

(6) In Schedule 3, the abbreviation “NPF” means the Nurse Prescribers' Formulary Appendix in the British National Formulary.

[F77 (7) In articles 12 to [F78 12E], a reference to a prescription only medicine being sold or supplied for the purpose of being administered in accordance with the written directions of a doctor or dentist relating to a particular person, or in accordance with a Patient Group Direction, includes a reference to it being sold or supplied in accordance with such directions or such a Direction.

(8) In articles 12A and 12C, a reference to an arrangement for the [F79 sale,] supply or adminstration of prescription only medicines includes a reference to an arrangement which covers such [F80 sale,] supply or administration and other matters.

(9) In Schedule 7, Part I, a reference to treatment of a clinical situation includes a reference to any form of management of that situation.]]

Textual Amendments

F1 Words in art. 1(2) inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(a)

F2 Words in art. 1(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(a)

F3 Words in art. 1(2) substituted (1.5.2004) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 Pt. 2 para. 13(a)

F4 Words in art. 1 omitted (1.4.2002) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(a)

F5 Words in art. 1(2) inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(a)

F6 Words in art. 1(2) inserted (20.11.2005) by The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), reg. 1(b), Sch. para. 5(a)

F7 Words in art. 1(2) inserted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(a)

F8 Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(b)

F9 Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(c)

F10 Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(d)

F11 Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(e)

F12 Words in art. 1(2) repealed (8.5.2009) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2009 (S.I. 2009/1165), arts. 1, 2

F13 Words in art. 1(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(d)

F14 Words in art. 1(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(e)

F15 Words in art. 1(2) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(f)

F16 Words in art. 1(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(f)

F17 Words in art. 1(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(g)

F18 Words in art. 1(2) substituted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(a)(i)

F19 Words in art. 1(2) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(a)(ii)

F20 Words in art. 1(2) substituted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(b)(i)

F21 Words in art. 1(2) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(b)(ii)

F22 Words in art. 1(2) substituted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(c)(i)

F23 Words in art. 1(2) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(c)(ii)

F24 Words in art. 1(2) inserted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 2(a)

F25 Words in art. 1(2) inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 2

F26 Words in art. 1(2) inserted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 2(b)

F27 Words in art. 1(2) omitted (17.11.2006) by virtue of The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 2(c)

F28 Words in art. 1(2) inserted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(g)

F29 Words in art. 1(2) inserted (1.4.2004) by The Health and Social Care (Community Health and Standards) Act 2003 (Supplementary and Consequential Provision) (NHS Foundation Trusts) Order 2004 (S.I. 2004/696), arts. 1(1)(b), 3(8), Sch. 8

F30 Words in art. 1(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(h)

F31 Words in art. 1(2) substituted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(d)

F32 Words in art. 1(2) substituted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 2(d)

F33 Words in art. 1(2) inserted (4.6.2008) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008 (S.I. 2008/1161), arts. 1(1), 2

F34 Words in art. 1(2) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(e)(i)(aa)

F35 Words in art. 1 substituted (10.12.2003) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2003 (S.I. 2003/2915), arts. 1(1), 2

F36 Words in art. 1(2) substituted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(e)(i)(bb)

F37 Words in art. 1(2) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(e)(ii)

F38 Words in art. 1(2) inserted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(h)

F39 Words in art. 1(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(i)

F40 Words in art. 1 inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(e)

F41 Words in art. 1(2) substituted (1.8.2004) by The Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004 (S.I. 2004/1771), art. 1(1), Sch. para. 39(a)(iv)

F42 Words in art. 1(2) inserted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 2(e)

F43 Words in art. 1 inserted (9.7.2003) by The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(2)(a)

F44 Words in art. 1(2) inserted (18.5.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2004 (S.I. 2004/1189), arts. 1(1), 2

F45 Words in art. 1(2) substituted (1.8.2004) by The Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004 (S.I. 2004/1771), art. 1(1), Sch. para. 39(a)(v)

F46 Words in art. 1(2) substituted (1.8.2004) by The Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004 (S.I. 2004/1771), art. 1(1), Sch. para. 39(a)(vi)

F47 Words in art. 1(2) inserted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(i)

F48 Words in art. 1(2) substituted (3.12.2007) by The European Qualifications (Health and Social Care Professions) Regulations 2007 (S.I. 2007/3101), regs. 1(2), 197

F49 Words in art. 1(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(j)

F50 Words in art. 1(2) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(f)(i)

F51 Words in art. 1(2) substituted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(f)(ii)

F52 Words in art. 1(2) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(g)(i)

F53 Words in art. 1(2) substituted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(g)(ii)

F54 Word in art. 1(2) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(j)

F55 Words in art. 1(2) inserted (1.8.2004) by The Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004 (S.I. 2004/1771), art. 1(1), Sch. para. 39(a)(vii)

F56 Word in art. 1(2) omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 3(a)(i)

F57 Words in art. 1(2) substituted (coming into force in accordance with art. 1(2)(3) of the amending S.I.) by The Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), Sch. 1 para. 20

F58 Word in art. 1(b) omitted (30.6.2005) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(b)(i)

F59 Words in art. 1(2) inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 3(a)(iii)

F60 Word in art. 1(c) inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(b)(ii)

F61 Words inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(b)(iii)

F62 Words in art. 1 omitted (9.7.2003) by virtue of The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(2)(b)

F63 Words in art. 1(2) inserted (1.10.2002) by The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2002 (S.I. 2002/2469), regs. 1, 7, Sch. 4

F64 Words in art. 1(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(k)

F65 Word in art. 1(2) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(k)(i)

F66 Word in art. 1(2) omitted (1.8.2004) by virtue of The Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004 (S.I. 2004/1771), art. 1(1), Sch. para. 39(a)(viii)

F67 Word in art. 1(2) omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 3(b)(i)

F68 Words in art. 1(2) inserted (1.8.2004) by The Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004 (S.I. 2004/1771), art. 1(1), Sch. para. 39(a)(viii)

F69 Word in art. 1(2)(c) omitted (30.6.2005) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(c)(i)

F70 Words in art. 1(2) inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 3(b)(iii)

F71 Word in art. 1(2)(d) inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(c)(ii)

F72 Art. 1(2)(e) inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(c)(iii)

F73 Words in art. 1(2) inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 3(c)

F74 Words in art. 1(2) inserted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(k)(ii)

F75 Words in art. 1(2) inserted (20.11.2005) by The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), reg. 1(b), Sch. para. 5(b)

F76 Words in art. 1(5) substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(3)

F77 Words in art. 1(7)-(9) inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(b)

F78 Word in art. 1(7) substituted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(3)

F79 Word in art. 1(8) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(3)(a)

F80 Word in art. 1(8) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(3)(b)

Appropriate practitioners

2.  For the purposes of section 58 (medicinal products on prescription only), the following shall be appropriate practitioners–

(a) in relation to the descriptions and classes of medicinal products specified in article 3, doctors, dentists [F81 , supplementary prescribers], [F82 nurse independent prescribers, pharmacist independent prescribers,] veterinary surgeons and veterinary practitioners;

[F83 (b) in relation to the descriptions and classes of medicinal products specified in Schedule 3, [F84 community practitioner nurse prescribers];

F85 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

[F86 (c) in relation to the descriptions and classes of medicinal products specified in article 3, other than medicinal products that are controlled drugs or for parenteral administration or both , optometrist independent prescribers.]

F85 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F81 Words in art. 2(a) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 3

F82 Words in art. 2(a) added (1.4.2008) by The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 2(a)

F83 Art. 2(b)(c) substituted for art. 2(b) (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 3

F84 Words in art. 2(b) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 3(a)

F85 Art. 2(c)(d) omitted (1.4.2008) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 2(b)

F86 Art. 2(c) inserted (4.6.2008) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008 (S.I. 2008/1161), arts. 1(1), 3

[F87 Medicinal products on prescription only

3.   The following descriptions and classes of medicinal products are specified for the purposes of section 58, namely—

(a) medicinal products in respect of which a marketing authorization has been granted, which in the marketing authorization are classified as being prescription only medicines;

(b) medicinal products in respect of which no marketing authorization has been granted consisting of or containing a substance listed in column 1 of Schedule 1;

(c) medicinal products that are for parenteral administration;

(d) medicinal products that are controlled drugs unless a marketing authorization has been granted in respect of that medicinal product in which the product is classified as being a pharmacy only or on general sale list medicine;

(e) cyanogenetic substances, other than preparations for external use;

(f) medicinal products that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used.

[F88 (g) medicinal products in respect of which a marketing authorization has been granted consisting of or containing aloxiprin, aspirin or paracetamol in the form of non-effervescent tablets or capsules which in the marketing authorization are classified as being pharmacy only or general sale list medicines.]

[F89 (h) medicinal products in respect of which a marketing authorization has been granted consisting of or containing pseudoephedrine salts or ephedrine base or salts in all pharmaceutical forms which in the marketing authorization are classified as being pharmacy only medicines.]]

Textual Amendments

F87 Art. 3 substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 4

F88 Art. 3(g) added (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 4

F89 Art. 3(h) inserted (1.4.2008) by The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 3

Prescribing and administration by nurse independent prescribers

F90 3A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F90 Art. 3A omitted (1.4.2008) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 4

[F91 Prescribing and administration by supplementary prescribers

3B.— (1) Subject to paragraph (2), a supplementary prescriber may—

(a) give a prescription for a medicinal product referred to in article 3; or

(b) if that medicinal product is for parenteral administration—

(i) administer that medicinal product, or

(ii) give directions for the administration of that medicinal product,

only where he complies with the conditions as to the cases or circumstances in which he may do so specified in paragraph (3).

[F92 (2) Paragraph (1) does not apply if the supplementary prescriber is a community practitioner nurse prescriber and the medicinal product prescribed or administered, or in respect of which he gives directions for administration, falls within a description or class of medicinal products specified in Schedule 3.]

(3) The conditions referred to in paragraph (1) are that—

(a) the supplementary prescriber is acting in accordance with the terms of a clinical management plan which—

(i) relates to the patient for whom the product is prescribed or to whom it is, or is to be, administered,

(ii) is in effect at the time the prescription or direction is given or, as the case may be, the product is administered, and

(iii) includes the particulars specified in Schedule 3B;

F93 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) the supplementary prescriber has access to the health records of the patient to whom the plan relates which are used by any doctor or dentist who is a party to the plan.

Textual Amendments

F91 Arts. 3B, 3C inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 6

F92 Art. 3B(2) substituted (1.4.2008) by The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 5

F93 Art. 3B(3)(b) omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 4

Exemptions from conditions in respect of the cases or circumstances in which a F94 ... supplementary prescriber may administer a medicinal product

3C.   The conditions specified by virtue of F95 ... article 3B(3) shall not apply in relation to the administration of a medicinal product by F96 ... a supplementary prescriber where—

(a) that person is acting in accordance with the directions of another person who is an appropriate practitioner, or

(b) that administration is exempt from the restriction in section 58(2)(b) (restriction on administration) by virtue of any of the subsequent provisions of this Order.]

Textual Amendments

F91 Arts. 3B, 3C inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 6

F94 Words in art. 3C heading omitted (1.4.2008) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 6(a)

F95 Words in art. 3C omitted (1.4.2008) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 6(b)(i)

F96 Words in art. 3C omitted (1.4.2008) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 6(b)(ii)

Duration of special provisions in relation to new medicinal products

F97 4.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F97 Art. 4 revoked (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 11

Exempt medicinal products

5.—(1) A medicinal product shall be exempt from the restrictions imposed by section 58(2)(a) (restrictions on sale or supply) if it, or a substance in it, is listed in column 1 of Schedule 1 and there–

(a) is an entry in column 2, 3, 4 or 5 of that Schedule which contains a condition and that condition is satisfied in accordance with the following provisions of this article; or

(b) there is more than one such condition which applies where that substance is used in that product and each of those conditions is so satisfied.

(2) Where a maximum strength is specified in column 2 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where the maximum strength of that substance in that medicinal product, or where specified in that column the maximum strength of a medicinal product which contains that substance, does not exceed that specified maximum or, where the medicinal product consists of more than one of the substances sodium fluoride, sodium monofluorophosphate or stannous fluoride combined in a dentifrice, where the maximum strength of that combination of substances in a product does not exceed the equivalent of 0.15 per cent of fluorine.

(3) Where a route of administration is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for administration only by that route.

(4) Where a use is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition in respect of use where it is sold or supplied only for use–

(a) where a purpose for which it may be used is so specified, for that purpose;

(b) where the class of persons in whom it may be used is so specified, in persons of that class [F98 ,

provided that, where the entry in column 3 contains a condition to the effect that the product is to be wholly or mainly for use in a specified class of persons, the product satisfies that condition where it is sold or supplied wholly or mainly for use in persons of that class].

(5) Where a pharmaceutical form is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied in that pharmaceutical form.

(6) Where a maximum dose is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use at a maximum dose which does not exceed that specified maximum dose.

(7) Subject to paragraph (8), where a maximum daily dose is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use at a maximum daily dose which does not exceed that specified maximum daily dose.

(8) A medicinal product which contains more than one of the substances–

• Atropine

• Atropine Methobromide

• Atropine Methonitrate

• Atropine Oxide Hydrochloride

• Atropine Sulphate

• Hyoscine

• Hyoscine Butylbromide

• Hyoscine Hydrobromide

• Hyoscine Methobromide

• Hyoscine Methonitrate

• Hyoscyamine

• Hyoscyamine Hydrobromide

• Hyoscyamine Sulphate,

satisfies the condition only where it is sold or supplied for use at a maximum daily dose which does not exceed 1 milligram in total of the alkaloids derived from belladonna, hyoscyamus, stramonium or other solanaceous plant which are contained in that medicinal product.

(9) Where a maximum period of use or a maximum frequency of use is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use for a maximum period or frequency, as the case may be, which does not exceed the maximum period of use or the maximum frequency of use which is so specified.

(10) Where a maximum quantity is specified in column 5 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it, or where so specified in that column, the medicinal product which contains that substance is sold or supplied in a quantity which does not exceed that specified maximum quantity.

(11) In paragraphs (2) to (7) and (9) and (10) a reference to a numbered column is a reference to the column bearing that number in Schedule 1.

Textual Amendments

F98 Words in art. 5(4) added (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 2

[F99 Exemption for products consisting of or containing aloxiprin, aspirin or paracetamol

5A.   A medicinal product falling within article 3(g) shall be exempt from the restrictions imposed by section 58(2) (restrictions on sale, supply and administration) if the quantity of that product sold or supplied to a person at any one time does not exceed 100 tablets or capsules.]

Textual Amendments

F99 Art. 5A inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 7

[F100 Exemption for products consisting of or containing pseudoephedrine salts or ephedrine base or salts

5B.— (1) A medicinal product falling within article 3(h) shall be exempt from the restrictions imposed by section 58(2) (restrictions on sale, supply and administration) if the conditions in paragraph (2) are satisfied—

(2) The conditions referred to in this paragraph are that—

(a) the medicinal product sold or supplied to a person must not be sold or supplied at the same time as another medicinal product that consists of or contains—

(i) in the case of pseudoephedrine salts, ephedrine base or salts;

(ii) in the case of ephedrine base or salts, pseudoephedrine salts; and

(b) the medicinal product or products sold or supplied to a person at any one time must not in total contain more than—

(i) in the case of pseudoephedrine salts, 720mg pseudoephedrine salts;

(ii) in the case of ephedrine base or salts, 180mg ephedrine base or salts. ]

Textual Amendments

F100 Art. 5B inserted (1.4.2008) by The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 7

Circumstances in which controlled drugs and medicinal products authorized by the European Community are not prescription only medicines

F101 6.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F101 Art. 6 revoked (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 11

Exemption for parenteral administration in an emergency to human beings of certain prescription only medicines

7.  The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration to human beings of any of the following medicinal products for parenteral administration–

• Adrenaline Injection 1 in 1000 (1 mg in 1 ml)

• Atropine Sulphate Injection

• [F102 Atropine sulphate and obidoxime chloride injection]

• [F102 Atropine sulphate and pralidoxime chloride injection]

• [F102 Atropine sulphate, pralidoxime mesilate and avizafone injection]

• [F103 Chlorphenamine Injection]

• [F104 Dicobalt Edetate Injection]

• F105 ...

• F105 ...

• Glucagon Injection

• [F106 Glucose Injection 50%]

• Hydrocortisone Injection

• [F107 Naloxone Hydrochloride]

• [F102 Pralidoxime chloride injection]

• [F102 Pralidoxime mesilate injection]

• Promethazine Hydrochloride Injection

• Snake Venom Antiserum

• Sodium Nitrite Injection

• Sodium Thiosulphate Injection

• Sterile Pralidoxime

where the administration is for the purpose of saving life in an emergency.

Textual Amendments

F102 Words in art. 7 inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 3

F103 Words in art. 7 substituted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 4(a)

F104 Words in art. 7 substituted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 4(b)

F105 Words in art. 7 omitted (30.6.2005) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 4(c)

F106 Words in art. 7 inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 4(d)

F107 Words in art. 7 substituted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 4(e)

[F108 Exemptions for administration of smallpox vaccine

7A.— (1) The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration to human beings of smallpox vaccine where the conditions specified in paragraph (2) or (3) are satisfied.

(2) The conditions referred to in this paragraph are—

(a) the vaccine has been supplied by, or on behalf of, or under arrangements made by—

(i) the Secretary of State,

(ii) the Scottish Ministers,

(iii) the National Assembly for Wales,

(iv) the Department of Health, Social Services and Public Safety,

(v) an NHS body; and

(b) the vaccine is administered for the purpose of providing protection against smallpox virus in the event of a suspected or confirmed case of smallpox in the United Kingdom.

(3) The conditions referred to in this paragraph are—

(a) the vaccine has been supplied by, or on behalf of, or under arrangements made by Her Majesty’s Forces;

(b) the vaccine is administered for the purpose of providing protection against smallpox virus to—

(i) members of Her Majesty’s Forces; or

(ii) other persons employed or engaged by those Forces.

(4) For the purposes of this regulation, “NHS body” means—

(a) the Common Services Agency,

(b) a Strategic Health Authority, Health Authority or Special Health Authority,

(c) a Primary Care Trust,

(d) a Local Health Board, or

(e) an NHS trust or NHS foundation trust]

Textual Amendments

F108 Art. 7A inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 4

[F109 Exemption for administration by operators

7B.— (1) The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to—

(a) a radioactive medicinal product, administration of which results in a medical exposure; or

(b) any other prescription only medicine if it is being administered in connection with a medical exposure,

where the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to in paragraph (1) are that—

(a) the radioactive medicinal product or other prescription only medicine is administered by an operator acting in accordance with the procedures and protocols referred to in regulation 4(1) and (2) of the Ionising Radiation (Medical Exposure) Regulations 2000 which apply to the exposure referred to in paragraph (1);

(b) that medical exposure has been authorised by an IRME practitioner or, where it is not practicable for an IRME practitioner to authorise the exposure, by an operator acting in accordance with written guidelines issued by an IRME practitioner;

(c) the IRME practitioner is the holder of a certificate granted pursuant to the Medicines (Administration of Radioactive Substances) Regulations 1978(5);

(d) the radioactive medicinal product or other prescription only medicine is not a controlled drug; and

(e) in the case of a prescription only medicine which is not a radioactive medicinal product, it is specified in the protocols referred to in sub-paragraph (a).]

Textual Amendments

F109 Art. 7B inserted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 3

Exemptions for emergency sale or supply

8.—(1) The restrictions imposed by section 58(2)(a) (restriction on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to in paragraph (1) are–

(a) that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied is satisfied that the sale or supply has been requested by a doctor [F110 , a supplementary prescriber] [F111 a community practitioner nurse prescriber, a nurse independent prescriber [F112 , an optometrist independent prescriber][F113 , dentist] or a pharmacist independent prescriber] who by reason of an emergency is unable to furnish a prescription immediately;

(b) that the doctor [F114 , supplementary prescriber] , [F115 community practitioner nurse prescriber, nurse independent prescriber [F116 , optometrist independent prescriber][F113 , dentist] or pharmacist independent prescriber] has undertaken to furnish the person lawfully conducting a retail pharmacy business with a prescription within 72 hours of the sale or supply;

(c) that the prescription only medicine is sold or supplied in accordance with the directions of the doctor [F117 , supplementary prescriber] , [F118 community practitioner nurse prescriber, nurse independent prescriber [F119 , optometrist independent prescriber][F113 , dentist] or pharmacist independent prescriber] requesting it;

(d) subject to paragraph (5), that the prescription only medicine is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations;

(e) that an entry is made in the record kept under regulation 6 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980(12) within the time specified in that regulation stating the particulars required under paragraph 1 of Schedule 2 to those Regulations.

(3) The restrictions imposed by section 58(2)(a) shall not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions specified in paragraph (4) are satisfied.

(4) The conditions referred to in paragraph (3) are–

(a) [F120 subject to paragraph (6)] that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied has interviewed the person requesting a prescription only medicine and has satisfied himself–

(i) that there is an immediate need for the prescription only medicine requested to be sold or supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay,

(ii) that treatment with the prescription only medicine requested has on a previous occasion been prescribed by a doctor [F121 , supplementary prescriber], [F122 community practitioner nurse prescriber, nurse independent prescriber [F123 , optometrist independent prescriber][F124 , dentist] or pharmacist independent prescriber] for the person requesting it, and

(iii) as to the dose which in the circumstances it would be appropriate for that person to take;

(b) that no greater quantity of the prescription only medicine than will provide 5 days' treatment [F125 in the case of a controlled drug or 30 days in any other case] is sold or supplied except that where the prescription only medicine–

(i) is [F126 a preparation of insulin,] an aerosol for the relief of asthma, an ointment or cream, and has been made up for sale in a container elsewhere than at the place of sale or supply, the smallest pack that the pharmacist has available for sale or supply may be sold or supplied,

(ii) is an oral contraceptive, a quantity sufficient for a full treatment cycle may be sold or supplied,

(iii) is an antibiotic for oral administration in liquid form, the smallest quantity that will provide a full course of treatment may be sold or supplied;

(c) subject to paragraph (5), that the prescription only medicine does not consist of or contain a substance specified in Schedule 4 to this Order and is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations;

(d) that an entry is made in the record kept under regulation 6 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 within the time specified in that regulation stating the particulars required under paragraph 3 of Schedule 2 to those Regulations;

(e) that the container or package of the prescription only medicine is labelled so as to show–

(i) the date on which the prescription only medicine is sold or supplied,

(ii) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine,

(iii) the name of the person requesting the prescription only medicine,

(iv) the name and address of the registered pharmacy from which the prescription only medicine is sold or supplied, and

(v) the words “Emergency Supply”.

(5) The conditions specified in paragraphs (2)(d) and (4)(c) shall not apply where the prescription only medicine consists of or contains phenobarbitone or phenobarbitone sodium (but no other substance specified in Schedule 4 to this Order or Schedule 1, 2 or 3 to the Misuse of Drugs Regulations) and is sold or supplied for use in the treatment of epilepsy.

[F127 (6) Paragraph (4)(a) does not apply in relation to the sale or supply of a prescription only medicine where—

(a) the sale or supply is made—

(i) whilst a disease is, or

(ii) in anticipation of a disease being imminently,

pandemic and a serious risk, or potentially a serious risk, to human health; and

(b) the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied has satisfied himself—

(i) that treatment with the prescription only medicine requested has on a previous occasion been prescribed by a doctor, supplementary prescriber, community practitioner nurse prescriber, nurse independent prescriber, optometrist independent prescriber or pharmacist independent prescriber for the person to be treated with it; and

(ii) as to the dose which in the circumstances it would be appropriate for that person to take.]

Textual Amendments

F110 Words in art. 8(2)(a) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 8(a)(i)

F111 Words in art. 8(2)(a) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 7(a)(i)

F112 Words in art. 8(2)(a) inserted (4.6.2008) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008 (S.I. 2008/1161), arts. 1(1), 4(a)(i)

F113 Word in art. 8(2) inserted (8.5.2009) by The Medicines for Human Use (Prescribing)(Miscellaneous Amendments) Order 2009 (S.I. 2009/1165), arts. 1, 3(a)

F114 Words in art. 8(2)(b) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 8(a)(ii)

F115 Words in art. 8(2)(b) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 7(a)(ii)

F116 Words in art. 8(2)(b) inserted (4.6.2008) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008 (S.I. 2008/1161), arts. 1(1), 4(a)(ii)

F117 Words in art. 8(2)(c) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 8(a)(iii)

F118 Words in art. 8(2)(c) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 7(a)(iii)

F119 Words in art. 8(2)(c) inserted (4.6.2008) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008 (S.I. 2008/1161), arts. 1(1), 4(a)(iii)

F120 Words in art. 8(4)(a) inserted (8.5.2009) by The Medicines for Human Use (Prescribing)(Miscellaneous Amendments) Order 2009 (S.I. 2009/1165), arts. 1, 3(b)(i)

F121 Words in art. 8(4)(a)(ii) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 8(b)

F122 Words in art. 8(4)(a)(ii) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 7(b)

F123 Words in art. 8(4)(a)(ii) inserted (4.6.2008) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008 (S.I. 2008/1161), arts. 1(1), 4(b)

F124 Word in art. 8(4)(a)(ii) inserted (8.5.2009) by The Medicines for Human Use (Prescribing)(Miscellaneous Amendments) Order 2009 (S.I. 2009/1165), arts. 1, 3(b)(ii)

F125 Words in art. 8(4)(b) inserted (8.5.2009) by The Medicines for Human Use (Prescribing)(Miscellaneous Amendments) Order 2009 (S.I. 2009/1165), arts. 1, 3(c)

F126 Words in art. 8(4)(b)(i) inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 2

F127 Art. 8(6) inserted (8.5.2009) by The Medicines for Human Use (Prescribing)(Miscellaneous Amendments) Order 2009 (S.I. 2009/1165), arts. 1, 3(d)

Exemption for non-parenteral administration to human beings

9.  The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration to human beings of a prescription only medicine which is not for parenteral administration.

Exemption for medicinal products at high dilutions

10.— [F128 (1)]  The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the sale, supply or administration of a medicinal product which is not for parenteral administration and which consists of or contains, any of the substances listed in column 1 of Schedule 1 [F129 or in Schedule 2], only one or more unit preparation of such substances, if–

(a) each such unit preparation has been diluted to at least one part in a million (6x), and the person selling, supplying or administering the medicinal product has been requested by or on behalf of a particular person and in that person’s presence to use his own judgment as to the treatment required; or

(b) each such unit preparation has been diluted to at least one part in a million million (6c).

[F130 (2) The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the sale, supply or administration of a medicinal product which is not for parenteral administration and which consists of or contains solely one or more unit preparations of the following substances—

• Aconite

• Arsenic Trioxide

• Belladonna Herb

• Ignatia Bean

• Nux Vomica Seed,

if each such unit preparation has been diluted to at least one part in a million (6x)]

Textual Amendments

F128 Art. 10 renumbered as art. 10(1) (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 9

F129 Words in art. 10(1) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 8

F130 Art. 10(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 9

Exemptions for certain persons

11.—(1) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply–

(a) to the sale or supply by a person listed in column 1 of Part I of Schedule 5 of the prescription only medicines listed in relation to that person in column 2 of that Part where the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied;

(b) to the supply by a person listed in column 1 of Part II of Schedule 5 of the prescription only medicines listed in relation to that person in column 2 of that Part where the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied.

(2) The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration by a person listed in column 1 of Part III of Schedule 5 of the prescription only medicines for parenteral administration listed in relation to that person in column 2 of that Part where the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied.

[F131 Exemption for sale or supply in hospitals

12.— (1) Subject to paragraph (3), the restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine in the course of the business of a hospital where the medicine is sold or supplied for the purpose of being administered (whether in the hospital or elsewhere) to a particular person in accordance with directions satisfying the conditions specified in paragraph (2).

(2) The conditions specified in paragraph (1) are that the directions—

(a) are in writing;

(b) relate to the particular person to whom the medicine is to be administered; and

(c) are given by a person (other than a veterinary surgeon or veterinary practitioner) who is an appropriate practitioner in relation to that medicine.

(3) Such directions may be given by F132 ... a supplementary prescriber only where he complies with any condition as to the cases or circumstances in which he may give a prescription for that medicine specified by virtue of article F133 ... 3B, as if the directions are a prescription.

(4) The exemption in paragraph (1) applies notwithstanding that the directions do not satisfy the conditions specified in article 15(2).]

Textual Amendments

F131 Art. 12 substituted (31.1.2004) by The Prescription Only Medicines (Human Use) Amendment Order 2004 (S.I. 2004/2), arts. 1(1), 2

F132 Words in art. 12(3) omitted (1.4.2008) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 8(a)

F133 Words in art. 12(3) omitted (1.4.2008) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 8(b)

[F134 Exemptions for the supply and administration of prescription only medicines by national health service bodies

12A.— (1) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the supply of a prescription only medicine by—

(a) the Common Services Agency;

(b) a [F135 Strategic Health Authority,] Health Authority or Special Health Authority;

(c) an NHS trust [F136 or NHS foundation trust];

(d) a Primary Care Trust; or

(e) where sub-paragraphs (a) to (d) do not apply, a person other than an excepted person, pursuant to an arrangement made with one of the persons specified in those sub-paragraphs for the supply of prescription only medicines,

where the medicine is supplied for the purpose of being administered to a particular person in accordance with the written directions of a doctor or dentist relating to that person notwithstanding that those directions do not satisfy the conditions specified in article 15(2).

(2) The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by—

(a) the Common Services Agency;

(b) a [F137 Strategic Health Authority,] Health Authority or Special Health Authority;

(c) an NHS trust [F138 or NHS foundation trust];

(d) a Primary Care Trust; or

(e) where sub-paragraphs (a) to (d) do not apply, a person other than an excepted person, pursuant to an arrangement made with one of the persons specified in those sub-paragraphs for the supply or, as the case may be, the administration of prescription only medicines,

where the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction and where the conditions specified in paragraph (3) are satisfied.

(3) The conditions referred to are that—

(a) the Patient Group Direction relates to the supply or, as the case may be, the administration, by the person who supplies or administers the medicine, of a description or class of prescription only medicine, and the Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

(b) the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

(c) the Patient Group Direction is signed on behalf of the person specified in column 2 of the Table in Part II of Schedule 7 to this Order (“the authorising person”) against the entry in column 1 of that Table for the class of person by whom the medicine is supplied or administered;

(d) the individual who supplies or, as the case may be, administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is designated in writing, on behalf of the authorising person, for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction; and

(e) at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.

(4) In this article, “excepted person” means—

(a) a doctor or dentist; or

(b) a person lawfully conducting a retail pharmacy business within the meaning of section 69.

Textual Amendments

F134 Arts. 12A-12C inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(d)

F135 Words in art. 12A(1)(b) inserted (1.10.2002) by The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2002 (S.I. 2002/2469), reg. 1, Sch. 1 para. 73(2)(a)

F136 Words in art. 12A(1)(c) inserted (1.4.2004) by The Health and Social Care (Community Health and Standards) Act 2003 (Supplementary and Consequential Provision) (NHS Foundation Trusts) Order 2004 (S.I. 2004/696), arts. 1(1)(b), 3(2), Sch. 2

F137 Words in art. 12A(2)(b) inserted (1.10.2002) by The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2002 (S.I. 2002/2469), reg. 1, Sch. 1 para. 73(2)(b)

F138 Words in art. 12A(2)(c) inserted (1.4.2004) by The Health and Social Care (Community Health and Standards) Act 2003 (Supplementary and Consequential Provision) (NHS Foundation Trusts) Order 2004 (S.I. 2004/696), arts. 1(1)(b), 3(2), Sch. 2

Exemption for health professionals who supply or administer prescription only medicines under a Patient Group Direction in order to assist doctors or dentists in providing national health services

12B.— (1) The restrictions imposed by section 58(2) (sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by an individual belonging to one of the classes specified in Part III of Schedule 7 to this Order where—

(a) the individual supplies or, as the case may be, administers the medicine in order to assist a doctor or dentist in the provision of, respectively, NHS primary medical services or NHS primary dental services;

(b) the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, in accordance with a Patient Group Direction; and

(c) the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to are that—

(a) the Patient Group Direction relates to the supply or, as the case may be, the administration of a description or class of prescription only medicine in order to assist the doctor or dentist in question in providing the services referred to in paragraph (1)(a) (whether or not it also relates to such supply or administration in order to assist any other doctor or dentist);

(b) the Patient Group Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

(c) the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

(d) the Patient Group Direction is signed—

(i) by the doctor or dentist in question or, alternatively, where the Direction also relates to supply or administration in order to assist one or more other doctors or dentists, as referred to in sub-paragraph (a), by one of those other doctors or dentists; and

[F139 (ii) on behalf of the Primary Care Trust, Local Health Board, Health Board or Health and Social Services Board that is responsible for the arrangements under which the services are provided]

(e) the individual referred to in paragraph (1) is designated in writing for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction, by the doctor or dentist in question, or, alternatively, where the Direction also relates to supply or administration in order to assist one or more other doctors or dentists, as referred to in sub-paragraph (a), by one of those other doctors or dentists; and

(f) at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.

(3) In this article—

(a) a reference to the provision of NHS primary dental services shall be construed as a reference to—

[F140 (i) in relation to England and Wales, the provision of primary dental services under Part 1 of the National Health Service Act 1977;]

(ii) in relation to Scotland, the provision of general dental services under Part II of the National Health Service (Scotland) Act 1978, or the performance of personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997; and

(iii) in relation to Northern Ireland, the provision of general dental services under the Health and Personal Social Services (Northern Ireland) Order 1972, or the performance of personal dental services in connection with a pilot scheme under the Health Services (Primary Care) (Northern Ireland) Order 1997;

(b) a reference to the provision of NHS primary medical services shall be construed as a reference to—

[F141 (i) in relation to England and Wales, the provision of primary medical services under Part I of the National Health Service Act 1977;]

[F142 (ii) in relation to Scotland, the provision of primary medical services under Part I of the National Health Service (Scotland) Act 1978; and]

[F143 (iii) in relation to Northern Ireland, the provision of primary medical services under Article 15B or Part VI of the Health and Personal Social Services (Northern Ireland) Order 1972.]

Textual Amendments

F134 Arts. 12A-12C inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(d)

F139 Art. 12B(2)(d)(ii) substituted (1.4.2006) by The General Dental Services, Personal Dental Services and Abolition of the Dental Practice Board Transitional and Consequential Provisions Order 2006 (S.I. 2006/562), art. 1(1), Sch. 1 para. 6(2)(a)

F140 Art. 12B(3)(a)(i) substituted (1.4.2006) by The General Dental Services, Personal Dental Services and Abolition of the Dental Practice Board Transitional and Consequential Provisions Order 2006 (S.I. 2006/562), art. 1(1), Sch. 1 para. 6(2)(b)

F141 Art. 12B(3)(b)(i) substituted (E.) (1.4.2004) by The General Medical Services and Personal Medical Services Transitional and Consequential Provisions Order 2004 (S.I. 2004/865), art. 1(1), Sch. 1 para. 18(2); and substituted (W.) by The General Medical Services Transitional and Consequential Provisions (Wales) (No. 2) Order 2004 (S.I. 2004/1016), art. 1(1), Sch. 1 para. 18(2)

F142 Art. 12B(3)(b)(ii) substituted (1.10.2004) by The Primary Medical Services (Scotland) Act 2004 (Consequential Amendments) Order 2004 (S.I. 2004/2261), art. 1(1), Sch. para. 2

F143 Art. 12B(3)(b)(iii) substituted (18.11.2004) by The Primary Medical Services (Northern Ireland) Order 2004 (Consequential Amendments) Order 2004 (S.I. 2004/3038), art. 1(1), Sch. para. 3

Exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction

12C.— (1) The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the [F144 sale or] supply or, as the case may be, the administration of a prescription only medicine by a person lawfully conducting a retail pharmacy business within the meaning of section 69 where—

[F145 (a) the medicine—

(i) is supplied, or as the case may be, is administered by such a person pursuant to an arrangement made with—

(aa) a body referred to in article 12A(a) to (d),

(bb) a force or service referred to in article 12E(1)(a)(i) to (iii), or

(cc) Her Majesty’s Forces,

for the supply or, as the case may be, the administration of prescription only medicines; or

(ii) is sold or supplied or, as the case may be, is administered by such a person pursuant to an arrangement made with an authority or person carrying on the business of an establishment or agency referred to in article 12D(1) for the sale or supply or, as the case may be, the administration of prescription only medicines;]

(b) the medicine is [F146 sold or] supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction; and

(c) the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to are that—

(a) the Patient Group Direction relates to the [F147 sale or] supply or, as the case may be, the administration of a description or class of prescription only medicine by the person lawfully conducting a retail pharmacy business who [F148 sells or] supplies or, as the case may be, administers the prescription only medicine, and the Direction has effect at the time at which the medicine is [F149 sold or] supplied or, as the case may be, is administered;

(b) the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

[F150 (c) the Patient Group Direction is signed—

(i) in the case of an arrangement with a body referred to in article 12A(a) to (d), on behalf of that body,

(ii) in the case of an arrangement with an authority or person carrying on the business of an establishment or agency referred to in article 12D(1), by or on behalf of the relevant provider and, if there is a relevant manager for the establishment or agency, that manager,

(iii) in the case of an arrangement with a prison service, by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that service,

(iv) in the case of an arrangement with a police force or the Police Service of Northern Ireland—

(a) by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that force or service, and

(b) a doctor who is not employed or engaged by, and who does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland, and

(v) in the case of an arrangement with Her Majesty’s Forces, by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for Her Majesty’s Forces;]

[F151 (cc) where the prescription only medicine is administered by the person lawfully conducting a retail pharmacy business within the meaning of section 69, the individual who administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is [F152 designated in writing—

(i) in the case of an arrangement with a body referred to in article 12A(a) to (d), on behalf of that body,

(ii) in the case of an arrangement with an authority or person carrying on the business of an establishment or agency referred to in article 12D(1), by or on behalf of the relevant provider or, if there is a relevant manager for the establishment or agency, that relevant manager,

(iii) in the case of an arrangement with a force or service referred to in article 12E(1)(a)(i) to (iii), by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that force or service, or

(iv) in the case of an arrangement with Her Majesty’s Forces, by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for Her Majesty’s Forces,

for the purpose of the administration of prescription only medicines under the Patient Group Direction; and]]

(d) at the time at which the medicine is [F153 sold or] supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.]

Textual Amendments

F134 Arts. 12A-12C inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(d)

F144 Words in art. 12C(1) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 3(a)(i)

F145 Art. 12C(1)(a) substituted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 3(a)(ii)

F146 Words in art. 12C(1)(b) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 3(a)(iii)

F147 Words in art. 12C(2)(a) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 3(b)(i)(aa)

F148 Words in art. 12C(2)(a) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 3(b)(i)(bb)

F149 Words in art. 12C(2)(a) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 3(b)(i)(cc)

F150 Art. 12C(2)(c) substituted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 10(b)(i)

F151 Art. 12C(2)(cc) inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 3(1)

F152 Words in art. 12C(2)(cc) substituted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 10(b)(ii)

F153 Words in art. 12C(2)(d) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 3(b)(ii)

[F154 Exemption for the supply and administration of prescription only medicines by independent hospitals, clinics and agencies

12D.— (1) The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the [F155 sale or] supply or, as the case may be, the administration of a prescription only medicine in the course of the business of—

[F156 (a) an independent hospital,

(b) an independent clinic,

(c) an independent medical agency, or

(d) in Northern Ireland, a nursing home,]

where the medicine is [F157 sold or] supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction and where the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to are that—

(a) the Patient Group Direction relates to the [F158 sale or] supply or, as the case may be, the administration, by the person who [F159 sells or] supplies or administers the medicine, of a description or class of prescription only medicine, and the Direction has effect at the time at which the medicine is [F160 sold or] supplied or, as the case may be, is administered;

(b) the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

(c) the Patient Group Direction is signed—

(i) by or on behalf of the registered provider, and

(ii) if there is a relevant manager for the independent hospital, clinic or agency, or nursing home, by that manager;

(d) the individual who [F161 sells or] supplies or, as the case may be, administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is designated in writing—

(i) by or on behalf of the registered provider, or

(ii) if there is a relevant manager for the independent hospital, clinic or agency, or nursing home, by that manager,

for the purpose of the [F162 sale or] supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction; and

(e) at the time at which the medicine is [F163 sold or] supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.

Textual Amendments

F154 Arts. 12D, 12E inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 11

F155 Words in art. 12D(1) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(a)(i)

F156 Art. 12D(1)(a)-(d) substituted for art. 12D(1)(a)(b) (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(a)(ii)

F157 Words in art. 12D(1) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(a)(iii)

F158 Words in art. 12D(2)(a) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(b)(i)(aa)

F159 Words in art. 12D(2)(a) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(b)(i)(bb)

F160 Words in art. 12D(2)(a) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(b)(i)(cc)

F161 Words in art. 12D(2)(d) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(b)(ii)(aa)

F162 Words in art. 12D(2)(d) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(b)(ii)(bb)

F163 Words in art. 12D(2)(e) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(b)(iii)

Exemption for health professionals who supply or administer prescription only medicines under a Patient Group Direction in order to assist the provision of health care by or on behalf of the police, the prison services or the armed forces

12E.— (1) The restrictions imposed by section 58(2) (sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by an individual belonging to one of the classes specified in Part III of Schedule 7 to this Order where—

(a) the individual supplies or, as the case may be, administers the medicine in order to assist the provision of health care by, on behalf of, or under arrangements made by—

(i) a police force in England, Wales or Scotland,

(ii) the Police Service of Northern Ireland,

(iii) a prison service, or

(iv) Her Majesty’s Forces;

(b) the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, in accordance with a Patient Group Direction; and

(c) the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to are that—

(a) the Patient Group Direction relates to the supply or, as the case may be, the administration of a description or class of prescription only medicine in order to assist the provision of health care by, or on behalf of, or under arrangements made by the police force or service, the prison service or, as the case may be, Her Majesty’s Forces;

(b) the Patient Group Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

(c) the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

(d) the Patient Group Direction is signed—

(i) by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order (“the authorising person”) against the entry in column 1 of that Table for the police force or service, the prison service or Her Majesty’s Forces by whom, or on whose behalf, the health care is provided, or with whom arrangements are made for the provision of such care; and

(ii) in the case of a police force or the Police Service of Northern Ireland, by a doctor who is not employed or engaged by, and who does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland;

(e) the individual referred to in paragraph (1) is designated in writing, by or on behalf of the authorising person, for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction; and

(f) at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.]

Textual Amendments

F154 Arts. 12D, 12E inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 11

[F164 Exemption for the supply of prescription only medicines in the event or anticipation of pandemic disease

12F.   The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the supply of a prescription only medicine by an individual where that supply is—

(a) made—

(i) whilst a disease is, or

(ii) in anticipation of a disease being imminently,

pandemic and a serious risk, or potentially a serious risk, to human health; and

(b) in accordance with a protocol which—

(i) is approved by—

(aa) the Ministers;

(bb) an NHS body (within the meaning of article 7A(4)); or

(cc) the Health Protection Agency established under section 1 of the Health Protection Agency Act 2004; and

(ii) contains criteria as to—

(aa) symptoms of, and treatment for, that disease;

(bb) the recording of the name of the person who supplies the prescription only medicine to the person to be treated (or to a person acting on that person’s behalf) and of the evidence that the medicine was supplied to the person to be treated (or to a person acting on that person’s behalf).]

Textual Amendments

F164 Art. 12F inserted (8.5.2009) by The Medicines for Human Use (Prescribing)(Miscellaneous Amendments) Order 2009 (S.I. 2009/1165), arts. 1, 4

Exemption in cases involving another’s default

13.  The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a person who, having exercised all due diligence, believes on reasonable grounds that the product sold or supplied is not a prescription only medicine.

[F165 Exemptions relating to prescriptions given by [F166 certain health professionals]

13A.— [F167 (1) The restrictions imposed by section 58(2)(a) (restrictions in sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by—

(a) another pharmacist,

(b) a registered nurse, F168 ...

(c) a registered midwife, F169 ...

[F170 (d) a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

(i) chiropodists and podiatrists;

(ii) physiotherapists; or

(iii) radiographers: diagnostic or therapeutic, [F171 or]]

[F172 (e) a registered optometrist,]

who is not an appropriate practitioner in relation to that medicine where the pharmacist selling or supplying the medicine, having exercised all due diligence, believes on reasonable grounds that the person is such a practitioner.]

(2) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by a F173 ... [F174 supplementary prescriber] where the pharmacist, having exercised all due diligence, believes on reasonable grounds that [F175 the F173 ...] [F174 supplementary prescriber] has complied with any condition with which he is required to comply by virtue of [F176 [F177 article] 3B].]

Textual Amendments

F165 Art. 13A inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 7

F166 Words in art. 13A heading substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 10(a)

F167 Art. 13A(1) substituted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 12(a)

F168 Word in art. 13A(1)(b) omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 5(a)

F169 Word in art. 13A(1)(c) omitted (30.6.2005) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 5(a)

F170 Art. 13A(1)(d) inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 5(c)

F171 Word in art. 13A(d) inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 5(b)

F172 Art. 13A(e) inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 5(c)

F173 Words in art. 13A(2) omitted (1.4.2008) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 9(a)

F174 Words in art. 13A(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 12(b)(i)

F175 Words in art. 13A(2) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 10(b)(ii)

F176 Words in art. 13A(2) substituted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 12(b)(ii)

F177 Word in art. 13A(2) substituted (1.4.2008) by The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 9(b)

Exemption in the case of a forged prescription

14.  The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a forged prescription where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.

Prescriptions

[F178 15.— (1) For the purposes of section 58(2)(a), and subject to paragraph (3), a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless the conditions specified in paragraph (2) are fulfilled.

(2) The conditions referred to in paragraph (1) are that the prescription—

(a) shall be signed in ink with his own name by the appropriate practitioner giving it;

(b) shall, without prejudice to sub-paragraph (a), be written in ink or otherwise so as to be indelible, unless it is a health prescription which is not for a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, in which case it may be written by means of carbon paper or similar material;

(c) shall contain the following particulars—

(i) the address of the appropriate practitioner giving it,

(ii) the appropriate date,

(iii) such particulars as indicate whether the appropriate practitioner giving it is a doctor, a dentist, a supplementary prescriber, [F179 a community practitioner nurse prescriber, a nurse independent prescriber[F180 , an optometrist independent prescriber], a pharmacist independent prescriber], a veterinary surgeon or a veterinary practitioner,

(iv) where the appropriate practitioner giving it is a doctor, dentist, a supplementary prescriber, [F181 a community practitioner nurse prescriber, a nurse independent prescriber[F182 , an optometrist independent prescriber] or a pharmacist independent prescriber] the name, address and the age, if under 12, of the person for whose treatment it is given, and

(v) where the appropriate practitioner giving it is a veterinary surgeon or a veterinary practitioner, the name and the address of the person to whom the prescription only medicine is to be delivered and a declaration by the veterinary surgeon or veterinary practitioner giving it that the prescription only medicine is prescribed for an animal or herd under his care;

(d) shall not be dispensed after the end of the period of 6 months from the appropriate date, unless it is a repeatable prescription in which case it shall not be dispensed for the first time after the end of that period nor otherwise than in accordance with the directions contained in the repeatable prescription;

(e) in the case of a repeatable prescription which does not specify the number of times it may be dispensed, shall not be dispensed on more than two occasions unless it is a prescription for an oral contraceptive in which case it may be dispensed 6 times before the end of the period of 6 months from the appropriate date.

(3) For the purposes of paragraph (1) the prescription may, as an alternative to fulfilling the conditions specified in paragraph (2)(a) and (b), fulfil instead the conditions specified in paragraph (4), unless the prescription is a health prescription for a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations or is given by a veterinary surgeon or a veterinary practitioner.

(4) The conditions referred to in paragraph (3) are that the prescription shall be created in electronic form and signed with an advanced electronic signature and transferred to the person by whom it is dispensed as an electronic communication (including where it is so transferred through one or more intermediaries).

(5) The prohibition on sale or supply imposed by section 58(2)(a) shall not apply where a prescription only medicine is sold or supplied other than in accordance with a prescription given by an appropriate practitioner and –

(a) the reason the sale or supply is not in accordance with such a prescription is that a condition specified in paragraph (2) or (4) is not fulfilled; and

(b) the person selling or supplying the prescription only medicine has exercised all due diligence and believes on reasonable grounds that the condition is fulfilled.

(6) In paragraph (2) “appropriate date” means—

(a) in the case of a health prescription, the date on which it was signed by the appropriate practitioner giving it or a date indicated by him as being the date before which it shall not be dispensed; and

(b) in every other case, the date on which the prescription was signed by the appropriate practitioner giving it,

and, for the purposes of sub-paragraphs (d) and (e) of that paragraph, where the health prescription bears both the date on which it was signed and a date indicated as being that before which it shall not be dispensed, the appropriate date is the later of those dates.

(7) In this Article—

“advanced electronic signature” means an electronic signature which is—

(a)

uniquely linked to the signatory,

(b)

capable of identifying the signatory,

(c)

created using means that the signatory can maintain under his sole control, and

(d)

which is linked to the data to which it relates in such a manner that any subsequent change of data is detectable;

“electronic communication” means a communication transmitted (whether from one person to another, from one device to another or from a person to a device or vice versa)—

(a)

by means of a telecommunication system (within the meaning of the Telecommunications Act 1984, or

(b)

by other means but while in an electronic form; and

“signatory” means the appropriate practitioner giving the prescription.]

Textual Amendments

F178 Art. 15 substituted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 6

F179 Words in art. 15(2)(c)(iii) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 11(a)

F180 Words in art. 15(2)(c)(iii) inserted (4.6.2008) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008 (S.I. 2008/1161), arts. 1(1), 5(a)

F181 Words in art. 15(2)(c)(iv) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 11(b)

F182 Words in art. 15(2)(c)(iv) inserted (4.6.2008) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008 (S.I. 2008/1161), arts. 1(1), 5(b)

Revocations

16.—(1) The Orders specified in Schedule 6 are revoked.

(2) In the Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 1989(13) articles 2 to 6 and Schedules 1 and 2 are revoked.

Signed by authority of the Secretary of State for Health

Baroness Jay

Minister of State,

Department of Health

Win Griffiths

Parliamentary Under Secretary of State, Welsh Office

Sam Galbraith

Parliamentary Under Secretary of State, The Scottish Office

Jeff Rooker

Minister of State, Ministry of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 22nd July 1997.

D. C. Gowdy

Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 18th July 1997.

P. Small

Permanent Secretary

Articles 3(a), 5(1) and 10

SCHEDULE 1 SUBSTANCES WHICH IF INCLUDED IN MEDICINAL PRODUCTS MAKE THOSE PRODUCTS PRESCRIPTION ONLY MEDICINES AND EXEMPTIONS FROM RESTRICTIONS ON THE SALE AND SUPPLY OF PRESCRIPTION ONLY MEDICINES

	Exemptions from the restrictions on the sale and supply of prescription only medicines
Column 1	Column 2	Column 3	Column 4		Column 5
Substance	Maximum strength	Route of administration, use or pharmaceutical form	Treatment limitations		Maximum quantity
[F183 Acamprosate]
Acarbose
Acebutolol Hydrochloride
[F183 Aceclofenac]
Acemetacin
Acetarsol
Acetazolamide
Acetazolamide Sodium
Acetohexamide
Acetylcholine Chloride	0.2 per cent	External
Acetylcysteine
Acipimox
Aciclovir	5.0 per cent	External			Container or package containing not more than 2g of medicinal product
		For treatment of herpes simplex virus infections of the lips and face (Herpes labialis)
Acitretin
Aclarubicin Hydrochloride
Aconite	1.3 per cent	External
Acrivastine			24 mg (MDD)		Container or package containing not more than 240mg of Acrivastine
Acrosoxacin
Actinomycin C
Actinomycin D
[F184 Adapalene]
Adenosine
Adrenaline		(1) By inhaler
		(2) External [F185 (except ophthalmic)]
Adrenaline Acid Tartrate		(1) By inhaler
		(2) External
Adrenaline Hydrochloride		(1) By inhaler
		(2) External
Adrenocortical Extract
Albendazole
Alclofenac
Alclometasone Dipropionate
Alcuronium Chloride
Aldesleukin
Aldosterone
[F183 Alendronate Sodium]
Alfacalcidol
Alfuzosin Hydrochloride
Allergen Extracts
Allopurinol
Allyloestrenol
[F186 Aloxiprin	(1) 620 mg	(1) Non-effervescent tablets and capsules			(1) The quantity sold or supplied in one container or package shall not exceed 32
					The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100
		(2) All preparations other than non-effervescent tablets or capsules]
Alphadolone Acetate
Alphaxalone
Alprenolol
Alprenolol Hydrochloride
Alprostadil
Alseroxylon
[F184 Altretamine]
Amantadine Hydrochloride
Ambenonium Chloride
Ambutonium Bromide
Amcinonide
Ametazole Hydrochloride
Amethocaine		Non-ophthalmic use
Amethocaine Gentisate		Non-ophthalmic use
Amethocaine Hydrochloride		Non-ophthalmic use
Amikacin Sulphate
Amiloride Hydrochloride
Aminocaproic Acid
Aminoglutethimide
Aminopterin Sodium
Amiodarone Hydrochloride
Amiphenazole Hydrochloride
[F187 Amisulpride]
Amitriptyline
Amitriptyline Embonate
Amitriptyline Hydrochloride
Amlodipine Besylate
Ammonium Bromide
Amodiaquine Hydrochloride
Amorolfine Hydrochloride
Amoxapine
Amoxycillin
Amoxycillin Sodium
Amoxycillin Trihydrate
Amphomycin Calcium
Amphotericin
Ampicillin
Ampicillin Sodium
Ampicillin Trihydrate
Amsacrine
Amygdalin
Amyl Nitrite
Amylocaine Hydrochloride		Non-ophthalmic use
[F183 Anastrozole]
Ancrod
Androsterone
Angiotensin Amide
Anistreplase
Anterior Pituitary Extract
Antimony Barium Tartrate
Antimony Dimercaptosuccinate
Antimony Lithium Thiomalate
Antimony Pentasulphide
Antimony Potassium Tartrate
Antimony Sodium Tartrate
Antimony Sodium Thioglycollate
Antimony Sulphate
Antimony Trichloride
Antimony Trioxide
Antimony Trisulphide
Apiol
Apomorphine
Apomorphine Hydrochloride
[F184 Apraclonidine Hydrochloride]
Aprotinin
Arecoline Hydrobromide
Argipressin
Aristolochia
Aristolochia Clematitis
Aristolochia Contorta
Aristolochia Debelis
Aristolochia Fang-chi
Aristolochia Manshuriensis
Aristolochia Serpentaria
Arsenic
Arsenic Triiodide
Arsenic Trioxide
Arsphenamine
[F188 Aspirin	[F189 (1) 75mg]	[F189 (1) Non-effervescent tablets and capsules]			[F189 (1) The quantity sold or supplied in one container or package shall not exceed 100 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100]
	[F190 [F191 (2)] 500 mg]	[F191 (2)] Non-effervescent tablets and capsules			[F191 (2)] The quantity sold or supplied in one container or package shall not exceed 32
		[F191 (3)] All preparations other than non-effervescent tablets or capsules			The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100]
Astemizole		F192 . . .	F192 . . .		F192 . . .
		F192 . . .
		F192 . . .
Atenolol
Atracurium Besylate
Atropine		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 300mcg (MD)
			1mg (MDD)
		(2) External (except ophthalmic)
Atropine Methobromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 400mcg (MD)
			1.3mg (MDD)
		(2) External (except ophthalmic)
Atropine Methonitrate		Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 400mcg (MD)
			1.3mg (MDD)
Atropine Oxide Hydrochloride		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 360mcg (MD)
			1.2mg (MDD) 3
		(2) External (except ophthalmic)
Atropine Sulphate		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 360mcg (MD)
			1.2mg (MDD)
		(2) External (except ophthalmic)
Auranofin
Azapropazone
Azathioprine
Azathioprine Sodium
Azelaic Acid
Azelastine Hydrochloride		For nasal administration	140mcg per nostril (MD)		Container or package containing not more than 5,040mcg of Azelastine Hydrochloride
		For the treatment of seasonal allergic rhinitis [F193 or perennial allergic rhinitis]	280mcg per nostril (MDD)
		For use in adults and children not less than [F194 5 years]
		As a non-aerosol, aqueous form
Azidocillin Potassium
Azithromycin
Azlocillin Sodium
Aztreonam
Bacampicillin Hydrochloride
Bacitracin
Bacitracin Methylene Disalicylate
Bacitracin Zinc
Baclofen
[F187 Balsalazide Sodium]
Bambuterol Hydrochloride
Barium Carbonate
Barium Chloride
Barium Sulphide
Beclamide
Beclomethasone
Beclomethasone Dipropionate		For nasal administration (non-aerosol)	100mcg per nostril (MD)		Container or package containing not more than [F195 20,000 mcg] of Beclomethasone Dipropionate
		For the prevention and treatment of allergic rhinitis	200 mcg per nostril (MDD)
			[F196 For a maximum period of 3 months]
		[F197 For use in persons aged 18 years and over]
Belladonna Herb		(1) Internal	(1) 1mg of the alkaloids (MDD)
		(2) External
Belladonna Root		(1) Internal	(1) 1mg of the alkaloids (MDD)
		(2) External
Bemegride
Bemegride Sodium
Benapryzine Hydrochloride
Bendrofluazide
Benethamine Penicillin
Benoxaprofen
Benperidol
[F187 Benserazide]
Benserazide Hydrochloride
Bentiromide
Benzathine Penicillin
Benzbromarone
Benzhexol Hydrochloride
Benzilonium Bromide
Benzocaine		Any use except ophthalmic use
Benzoctamine Hydrochloride
Benzoyl Peroxide	10.0 per cent	External
N-Benzoyl Sulphanilamide
Benzquinamide
Benzquinamide Hydrochloride
Benzthiazide
Benztropine Mesylate
Benzylpenicillin Calcium
Benzylpenicillin Potassium
Benzylpenicillin Sodium
Beractant
Betahistine Hydrochloride
Betamethasone
Betamethasone Adamantoate
Betamethasone Benzoate
Betamethasone Dipropionate
Betamethasone Sodium Phosphate
Betamethasone Valerate
Betaxolol Hydrochloride
Bethanechol Chloride
Bethanidine Sulphate
Bezafibrate
[F184 Bicalutamide]
Biperiden Hydrochloride
Biperiden Lactate
Bismuth Glycollylarsanilate
Bisoprolol Fumarate
Bleomycin
Bleomycin Sulphate
Bretylium Tosylate
[F187 Brimonidine Tartrate]
Bromhexine Hydrochloride
Bromocriptine Mesylate
Bromperidol
Bromvaletone
Brotizolam
Budesonide		For nasal administration	200mcg per nostril (MD)		Container or package containing not more than 10mg of Budesonide
		For the prevention or treatment of seasonal allergic rhinitis	[F196 For a maximum period of 3 months]
		200 mcg per nostril (MDD)
		[F197 For use in persons aged 18 years and over]
		As a non-aerosol, aqueous form
Bufexamac
Bumetanide
Buphenine Hydrochloride			6mg (MD)
			18mg (MDD)
Bupivacaine		Any use except ophthalmic use
Bupivacaine Hydrochloride		Any use except ophthalmic use
Buserelin Acetate
Buspirone Hydrochloride
Busulphan
Butacaine Sulphate		Any use except ophthalmic use
Butorphanol Tartrate
Butriptyline Hydrochloride
[F198 Cabergoline]
Calcipotriol
[F184 Calcipotriol Hydrate]
Calcitonin
Calcitriol
Calcium Amphomycin
Calcium Benzamidosalicylate
Calcium Bromide
Calcium Bromidolactobionate
Calcium Carbimide
Calcium Folinate
Calcium Metrizoate
Calcium Sulphaloxate
[F199 Candesartan Cilexetil]
Candicidin
Canrenoic Acid
Cantharidin	0.01 per cent	External
Capreomycin Sulphate
Captopril
Carbachol
Carbamazepine
Carbaryl
[F187 Carbasalate Calcium]
Carbenicillin Sodium
Carbenoxolone Sodium		(1) Pellet	(1) 5mg (MD)
			25mg (MDD)
	(2) 2.0 per cent	(2) Gel
	(3) 1.0 per cent	(3) Granules for mouthwash in adults and children not less than 12 years	(3) 20mg (MD)		(3) Container or package containing not more than [F200 560mg] of Carbenoxolone Sodium
			80mg (MDD)
Carbidopa
Carbimazole
Carbocisteine
Carbon Tetrachloride
Carboplatin
Carboprost Trometamol
Carbuterol Hydrochloride
Carfecillin Sodium
Carindacillin Sodium
Carisoprodol
Carmustine
Carperidine
Carteolol Hydrochloride
Cefaclor
Cefadroxil
Cefazedone Sodium
[F187 Cefdinir]
Cefixime
Cefodizime Sodium
Cefotaxime Sodium
Cefoxitin Sodium
Cefpodoxime Proxetil
[F198 Cefprozil]
Cefsulodin Sodium
Ceftazidime
Ceftizoxime Sodium
Ceftriaxone Sodium
Cefuroxime Axetil
Cefuroxime Sodium
Celiprolol Hydrochloride
Cephalexin
Cephalexin Sodium
Cephaloridine
Cephalothin Sodium
Cephamandole Nafate
Cephazolin Sodium
Cephradine
Cerium Oxalate
Cerivastatin
[F187 Cerivastatin Sodium]
Ceruletide Diethylamine
Cetirizine Hydrochloride			10mg (MDD)		F201 . . .
Chenodeoxycholic Acid
Chloral Hydrate		External
Chlorambucil
Chloramphenicol
Chloramphenicol Cinnamate
Chloramphenicol Palmitate
Chloramphenicol Sodium Succinate
Chlorhexadol
Chlormadinone Acetate
Chlormerodrin
Chlormethiazole
Chlormethiazole Edisylate
Chlormezanone
Chloroform(14)	(1) 5.0 per cent	(1) Internal
		(2) External
Chloroquine Phosphate		Prophylaxis of malaria
Chloroquine Sulphate		Prophylaxis of malaria
Chlorothiazide
Chlorotrianisene
Chlorphenoxamine Hydrochloride
Chlorpromazine
Chlorpromazine Embonate
Chlorpromazine Hydrochloride
Chlorpropamide
Chlorprothixene
Chlorprothixene Hydrochloride
Chlortetracycline
Chlortetracycline Calcium
Chlortetracycline Hydrochloride
Chlorthalidone
Chlorzoxazone
Cholestyramine
Ciclacillin
Ciclobendazole
Cilastatin Sodium
Cilazapril
Cimetidine		(a) For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity and for the prophylaxis of meal-induced heartburn	(a) 200mg (MD)
			800mg (MDD)
			For a maximum period of 14 days
		(b) For the prophylactic management of nocturnal heartburn by a single dose taken at night	(b) 100mg (MD) to be taken as a single dose at night
			For a maximum period of 14 days
Cimetidine Hydrochloride
Cinchocaine	3.0 per cent	Non-ophthalmic use
Cinchocaine Hydrochloride	Equivalent of 3.0 per cent of Cinchocaine	Non-ophthalmic use
Cinchophen
Cinoxacin
Ciprofibrate
Ciprofloxacin
Ciprofloxacin Hydrochloride
Cisapride
Cisplatin
[F184 Citalopram Hydrobromide]
Clarithromycin
Clavulanic Acid
Clidinium Bromide
Clindamycin
Clindamycin Hydrochloride
Clindamycin Palmitate Hydrochloride
Clindamycin Phosphate
Clioquinol		(1) External (other than treatment of mouth ulcers)
	(2) 35mg	(2) Treatment of mouth ulcers	(2) 350mg (MDD)
Clobetasol Propionate
Clobetasone Butyrate	[F202 0.05 per cent]	[F202 Cream for use in adults and in children aged 12 years and over, for external use for the short term symptomatic treatment and control of patches of eczema and dermatitis (excluding seborrhoeic dermatitis)]			[F202 Container or package containing not more than 15g of medicinal product]
Clofazimine
Clofibrate
Clomiphene Citrate
Clomipramine
Clomipramine Hydrochloride
Clomocycline
Clomocycline Sodium
Clonidine
Clonidine Hydrochloride
Clopamide
Clopenthixol Decanoate
Clopenthixol Hydrochloride
Clorexolone
Clotrimazole		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Cloxacillin Benzathine
Cloxacillin Sodium
Clozapine
Cocculus Indicus
Co-dergocrine Mesylate
Colaspase
Colchicine
Colestipol Hydrochloride
Colfosceril Palmitate
Colistin Sulphate
Colistin Sulphomethate
Colistin Sulphomethate Sodium
Coniine
Conium Leaf	7.0 per cent	External
Corticotrophin
Cortisone
Cortisone Acetate
Co-tetroxazine
Co-trimoxazole
Cropropamide
Crotethamide
Croton Oil
Croton Seed
Curare
Cyclofenil
Cyclopenthiazide
Cyclopentolate Hydrochloride
Cyclophosphamide
Cycloserine
Cyclosporin
Cyclothiazide
Cyproterone Acetate
Cytarabine
Cytarabine Hydrochloride
Dacarbazine
Dalteparin Sodium
Danazol
Danthron
Dantrolene Sodium
Dapsone
Dapsone Ethane Ortho Sulphonate
Daunorubicin Hydrochloride
Deanol Bitartrate			26mg (MDD)
Debrisoquine Sulphate
Demecarium Bromide
Demeclocycline
Demeclocycline Calcium
Demeclocycline Hydrochloride
Deoxycortone Acetate
Deoxycortone Pivalate
Deptropine Citrate
Dequalinium Chloride	(1) 0.25mg	(1) Internal: throat lozenges or throat pastilles
	(2) 1.0 per cent	(2) External: paint
Deserpidine
Desferrioxamine Mesylate
Desflurane
Desipramine Hydrochloride
Deslanoside
Desmopressin
Desmopressin Acetate
Desogestrel
Desonide
Desoxymethasone
Dexamethasone
Dexamethasone Acetate
Dexamethasone Isonicotinate
Dexamethasone Phenylpropionate
Dexamethasone Pivalate
Dexamethasone Sodium Metasulphobenzoate
Dexamethasone Sodium Phosphate
Dexamethasone Troxundate
Dexfenfluramine Hydrochloride
Dextromethorphan Hydrobromide		Internal	(a) In the case of a prolonged release preparation: equivalent of 30mg of Dextromethorphan (MD)
			equivalent of 75mg of Dextromethorphan (MDD)
			(b) in any other case: equivalent of 15mg of Dextromethorphan (MD)
			equivalent of 75mg of Dextromethorphan (MDD)
Dextrothyroxine Sodium
Diazoxide
Dibenzepin Hydrochloride
Dichloralphenazone
Dichlorphenamide
Diclofenac Diethylammonium	1.16 per cent	External	For maximum period of 7 days		Container or package containing not more than 30g of medicinal product
		For local symptomatic relief of pain and inflammation in trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism
		For use in adults and children not less than 12 years
Diclofenac Potassium
Diclofenac Sodium
Dicyclomine Hydrochloride			10mg (MD)
			60mg (MDD)
[F183 Didanosine]
Dienoestrol
Diethanolamine Fusidate
Diflucortolone Valerate
Diflunisal
Digitalin
Digitalis Leaf
Digitalis Prepared
Digitoxin
Digoxin
Dihydralazine Sulphate
Dihydroergotamine Mesylate
Dihydrostreptomycin
Dihydrostreptomycin Sulphate
Diloxanide Furoate
Diltiazem Hydrochloride
Dimercaprol
Dimethisoquin Hydrochloride		Non-ophthalmic use
Dimethisterone
Dimethothiazine Mesylate
Dimethyl Sulphoxide
Dimethyltubocurarine Bromide
Dimethyltubocurarine Chloride
Dimethyltubocurarine Iodide
Dinoprost
Dinoprost Trometamol
Dinoprostone
[F186 Diphenhydramine Hydrochloride	All preparations except liquid-filled capsules]
[F203 Diphenoxylate Hydrochloride]	[F203 2.5 mg]	[F203 In combination with Atropine Sulphate for short term use as an adjunctive therapy to appropriate rehydration in acute diarrhoea	[F203 25 mg (MDD)]		[F203 Container or package containing not more than 20 tablets]
		For use in persons aged 16 years and over
		Tablets]
Dipivefrin Hydrochloride
Dipyridamole
Disodium Etidronate
Disodium Pamidronate
Disopyramide
Disopyramide Phosphate
Distigmine Bromide
Disulfiram
Dithranol	1.0 per cent
Dobutamine Hydrochloride
[F203 Dolasetron Mesilate]
Domperidone		[F204 For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn]	[F204 10mg of Domperidone (MD)]		[F204 Container or package containing not more than 200mg of Domperidone]
			[F204 40mg of Domperidone (MDD)]
Domperidone Maleate		[F205 For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn,]	[F206 10 mg of Domperidone as Domperidone Maleate (MD)]		[F205 Container or package containing not more than [F207 200mg] of Domperidone as Domperidone Maleate;]
			[F206 40 mg of Domperidone as Domperidone Maleate (MDD)]
[F187 Donepezil Hydrochloride]
Dopamine Hydrochloride
Dopexamine Hydrochloride
[F184 Dorzolamide Hydrochloride]
Dothiepin
Dothiepin Hydrochloride
Doxapram Hydrochloride
Doxazosin Mesylate
Doxepin Hydrochloride
Doxorubicin
Doxorubicin Hydrochloride
Doxycycline
Doxycycline Calcium Chelate
Doxycycline Hydrochloride
Droperidol
Dydrogesterone
Dyflos
Econazole		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Econazole Nitrate		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Ecothiopate Iodide
Edrophonium Chloride
Eflornithine Hydrochloride
[F183 Eformoterol Fumarate]
Embutramide
Emepronium Bromide
Emetine	1.0 per cent
Emetine Bismuth Iodide
Emetine Hydrochloride	Equivalent of 1.0 per cent of Emetine
Enalapril Maleate
Encephalitis Virus, Tick-borne, Cent Eur
Enoxacin
Enoxaparin Sodium
Enoximone
Ephedrine		(1) Internal (other than nasal sprays or nasal drops)	(1) 30mg (MD)
			60mg (MDD)
	(2) 2.0 per cent	(2) Nasal sprays or nasal drops
		(3) External
Ephedrine Hydrochloride		(1) Internal (other than nasal sprays or nasal drops)	(1) Equivalent of 30mg of Ephedrine (MD)
			Equivalent of 60mg of Ephedrine (MDD)
	(2) Equivalent of 2.0 per cent of Ephedrine	(2) Nasal sprays or nasal drops
		(3) External
Ephedrine Sulphate		(1) Internal (other than nasal sprays or nasal drops)	(1) Equivalent of 30mg of Ephedrine (MD)
			Equivalent of 60mg of Ephedrine (MDD)
	(2) Equivalent of 2.0 per cent of Ephedrine	(2) Nasal sprays or nasal drops
		(3) External
Epicillin
Epirubicin
Epirubicin Hydrochloride
Epithiazide
Epoetin Alfa
Epoetin Beta
Epoprostenol Sodium
Ergometrine Maleate
Ergometrine Tartrate
Ergot, Prepared
Ergotamine Tartrate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylcarbonate
Erythromycin Ethyl Succinate
Erythromycin Lactobionate
Erythromycin Phosphate
Erythromycin Stearate
Erythromycin Thiocyanate
Esmolol Hydrochloride
Estramustine Phosphate
[F208 Estramustine Sodium Phosphate]
Etafedrine Hydrochloride
Ethacrynic Acid
Ethambutol Hydrochloride
Ethamivan
Ethamsylate
Ethiazide
Ethinyl Androstenediol
Ethinyloestradiol
Ethionamide
Ethisterone
Ethoglucid
Ethoheptazine Citrate
Ethopropazine Hydrochloride
Ethosuximide
Ethotoin
Ethyl Biscoumacetate
Ethynodiol Diacetate
Etodolac
Etomidate
Etomidate Hydrochloride
Etoposide
Etretinate
[F184 Exemestane]
Famciclovir
Famotidine		For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity, and prevention of these symptoms when associated with food and drink, including nocturnal symptoms	10mg (MD)
			20mg (MDD)
			For maximum period of 14 days
Fazadinium Bromide
Felbinac	3.17 per cent	External	For maximum period of 7 days		Container or package containing not more than [F209 50g] of medicinal product
		[F210 For the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions]
		For use in adults and children not less than 12 years
Felodipine
Felypressin
Fenbufen
Fenclofenac
Fenfluramine Hydrochloride
Fenofibrate
Fenoprofen
Fenoprofen Calcium
Fenoterol Hydrobromide
Fenticonazole Nitrate		[F202 External use (but in the case of vaginal use, only for the treatment of vaginal candidiasis)]
Feprazone
Ferrous Arsenate
[F184 Ferumoxsil]
[F187 Fexofenadine Hydrochloride]
Filgrastim
Finasteride
Flavoxate Hydrochloride
Flecainide Acetate
Flosequinan
Fluanisone
Flubendazole
Fluclorolone Acetonide
Flucloxacillin Magnesium
Flucloxacillin Sodium
Fluconazole		For oral administration for the treatment of vaginal candidiasis [F211 or associated candidal balanitis] in persons aged not less than 16 but less than 60 years	150mg (MD)		Container or package containing not more than 150mg of Fluconazole
Flucytosine
Fludrocortisone Acetate
Flufenamic Acid
Flumazenil
Flumethasone
Flumethasone Pivalate
Flunisolide	0.025 per cent	(a) For the prevention and treatment of seasonal allergic rhinitis, including hay fever	(a) 50mcg per nostril (MD)		(a) Container or package containing not more than 6,000mcg of Flunisolide
			100mcg per nostril (MDD)
		[F212 For use in persons aged 18 years and over]	[F213 For a maximum period of 3 months]
		In the form of a non-pressurised nasal spray
		F214 ...	F214 ...		F214 ...
			F214 . . .
		F214 . . .
		F214 . . .
Fluocinolone Acetonide
Fluocinonide
Fluocortin Butyl
Fluocortolone
Fluocortolone Hexanoate
Fluocortolone Pivalate
Fluorescein Dilaurate
Fluorometholone
Fluorouracil
Fluorouracil Trometamol
Fluoxetine Hydrochloride
Flupenthixol Decanoate
Flupenthixol Hydrochloride
Fluperolone Acetate
Fluphenazine Decanoate
Fluphenazine Enanthate
Fluphenazine Hydrochloride
Fluprednidene Acetate
Fluprednisolone
Fluprostenol Sodium
Flurandrenolone
Flurbiprofen	[F215 8.75 mg]	[F216 Throat lozenges]	[F217 43.75 mg (MDD)]		[F218 Container or package containing not more than 140 mg of Flurbiprofen]
Flurbiprofen Sodium
Fluspirilene
Flutamide
Fluticasone Propionate
[F187 Flutrimazole]
Fluvastatin Sodium
Fluvoxamine Maleate
Folic Acic			500mcg (MDD)
Formestane
Formocortal
Foscarnet Sodium
Fosfestrol Sodium
Fosfomycin Trometamol
Fosinopril Sodium
Framycetin Sulphate
Frusemide
Furazolidone
Fusafungine
Fusidic Acid
Gabapentin
Gadoteridol
Gallamine Triethiodide
Ganciclovir
Ganciclovir Sodium
Gelsemine	0.1 per cent
Gelsemium			25mg (MD)
			75mg (MDD)
Gemeprost
Gemfibrozil
Gentamicin
Gentamicin Sulphate
Gestodene
Gestrinone
Gestronol
Gestronol Hexanoate
Glibenclamide
Glibornuride
Gliclazide
Glipizide
Gliquidone
Glisoxepide
Glucagon
Glycopyrronium Bromide			1mg (MD)
			2mg (MDD)
Glymidine
Gonadorelin
Goserelin Acetate
Gramicidin	0.2 per cent	External
Granisetron Hydrochloride
Griseofulvin
Growth Hormone
Guanethidine Monosulphate
Guanfacine Hydrochloride
Guanoclor Sulphate
Guanoxan Sulphate
Halcinonide
Halofantrine Hydrochloride
Haloperidol
Haloperidol Decanoate
Heparin		External
Heparin Calcium		External
Heparin Sodium
Hexachlorophane		External
	(a) 2.0 per cent	(a) Soaps
	(b) 0.1 per cent	(b) Aerosols
	(c) 0.75 per cent	(c) preparations other than soaps and aerosols
Hexamine Phenylcinchoninate
Hexobarbitone
Hexobarbitone Sodium
Hexoestrol
Hexoestrol Dipropionate
L-Histidine Hydrochloride		Dietary supplementation
Homatropine		(1) Internal	(1) 0.15mg (MD)
			0.45mg (MDD)
		(2) External (except ophthalmic)
Homatropine Hydrobromide			0.2mg (MD)
			0.6mg (MDD)
Homatropine Methylbromide			2mg (MD)
			6mg (MDD)
Hydralazine Hydrochloride
Hydrargaphen		Local application to skin
Hydrobromic Acid
Hydrochlorothiazide
Hydrocortisone	[F219 (1) 0.5 per cent]	[F219 (1) External (a) For use in combination with Nystatin of maximum strength 3.0 per cent for intertrigo (b) For use in adults and children not less than 10 years]			[F219 (1) Container or package containing not more than 15g of medicinal product]
	[F220 (2)] 1.0 per cent	[F220 (2)] External (a) For use either alone or in conjunction with Crotamiton in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and either in combination with Clotrimazole [F221 or Miconazole Nitrate] for athlete’s foot and candidal intertrigo or in combination with lignocaine for anal and perianal itch associated with haemorrhoids (b) For use in adults and children not less than 10 years (c) Cream ointment or spray			[F220 (2)] Container or package containing not more than 15g of medicinal product (cream or ointment) or 30ml (spray)
Hydrocortisone Acetate	Equivalent to 1.0 per cent Hydrocortisone	External
		For use in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and in combination with one or more of the following: Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Peru Balsam, Pramoxine Hydrochloride, Zinc Oxide, for haemorrhoids [F222 or in combination with Miconazole Nitrate, for athlete’s foot and candidal intertrigo]			Container or package containing not more than 15g of medicinal product
					In the case of suppositories, container or package containing no more than 12
		For use in adults and children not less than 10 years
		Cream, ointment or suppositories
Hydrocortisone Butyrate
Hydrocortisone Caprylate
Hydrocortisone Hydrogen Succinate
Hydrocortisone Sodium Phosphate
Hydrocortisone Sodium Succinate	Equivalent to 2.5mg Hydrocortisone	External			Container or package containing not more than equivalent to 50mg of Hydrocortisone
		For aphthous ulceration of the mouth for adults and children not less than 12 years
		In the form of pellets
[F186 Hydrocyanic Acid]
Hydroflumethiazide
Hydroxychloroquine Sulphate		Prophylaxis of malaria
Hydroxyprogesterone
Hydroxyprogesterone Enanthate
Hydroxyprogesterone Hexanoate
Hydroxyurea
Hydroxyzine Embonate
Hydroxyzine Hydrochloride		(a) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in adults and in children not less than 12 years	(a) 25mg (MD)		(a) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride
			75mg (MDD)
		(b) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in children not less than 6 years but less than 12 years	(b) 25 mg (MD)		(b) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride
			50mg (MDD)
Hyoscine	(1) 0.15 per cent	(1) Internal
		(2) External (except ophthalmic)
Hyoscine Butylbromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 20mg (MD)		(b) Container or package containing not more than 240mg of Hyoscine Butylbromide
			80mg (MDD)
		(2) External
Hyoscine Hydrobromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 300mcg (MD)
			900mcg (MDD)
		(2) External (except ophthalmic)
Hyoscine Methobromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 2.5mg (MD)
			7.5mg (MDD)
		(2) External
Hyoscine Methonitrate		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 2.5mg (MD)
			7.5mg (MDD)
		(2) External
Hyoscyamine		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 300mcg (MD)
			1mg (MDD)
		(2) External
Hyoscyamine Hydrobromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) Equivalent of 300mcg of Hyoscyamine (MD)
			Equivalent of 1mg of Hyoscyamine (MDD)
		(2) External
Hyoscyamine Sulphate		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) Equivalent of 300mcg of Hyoscyamine (MD)
			Equivalent of 1mg of Hyoscyamine (MDD)
		(2) External
Ibuprofen		Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza
		(1) Internal	(1)(a) In the case of a prolonged release preparation 600mg (MD)
			1,200mg (MDD)
			(b) in any other case 400mg (MD)
			1,200mg (MDD)
	(2) 5.0 per cent	(2) External
	[F223 (3) 10.0 per cent]	[F223 (3) External]	[F223 (3) 125 mg (MD) 500 mg (MDD)]		[F223 (3) Container or package containing not more than [F224 50g] of medicinal product]
[F186 Ibuprofen Lysine		Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza	(a) in the case of a prolonged release preparation 600 mg (MD) 1,200 mg (MDD)
		Internal	(b) in any other case 400 mg (MD) 1,200 mg (MDD)]
Idarubicin Hydrochloride
Idoxuridine
Ifosfamide
Ignatius Bean
[F183 Imidapril Hydrochloride]
Imipenem Hydrochloride
Imipramine
Imipramine Hydrochloride
Imipramine Ion Exchange Resin Bound Salt or Complex
[F198 Indapamide]
Indapamide Hemihydrate
Indomethacin
Indomethacin Sodium
Indoprofen
Indoramin Hydrochloride
Inosine Pranobex
[F225 Insulin]
Iodamide
Iodamide Meglumine
Iodamide Sodium
Iohexol
Iomeprol
Iopamidol
Iopentol
Iothalamic Acid
Ioversol
Ioxaglic Acid
Ipratropium Bromide
Iprindole Hydrochloride
Iproniazid Phosphate
[F187 Irbesartan]
Isoaminile
Isoaminile Citrate
Isocarboxazid
Isoconazole Nitrate		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Isoetharine
Isoetharine Hydrochloride
Isoetharine Mesylate
Isoniazid
Isoprenaline Hydrochloride
Isoprenaline Sulphate
Isopropamide Iodide			Equivalent of 2.5mg of Isopropamide ion (MD)
			Equivalent of 5.0mg of Isopropamide ion (MDD)
Isotretinoin
Isradipine
Itraconazole
Jaborandi		External
Kanamycin Acid Sulphate
Kanamycin Sulphate
Ketamine Hydrochloride
Ketoconazole	2.0 per cent	[F226 (a)] [F227 External]	[F226 (a)] Maximum frequency of application of once every 3 days		[F226 (a)] Container or package containing not more than 120ml of medicinal product and containing not more than 2,400mg of Ketoconazole
		For the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalp
		In the form of a shampoo
		[F228 (b) For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo]
Ketoprofen	2.5 per cent	External	For maximum period of 7 days		Container or package containing not more than 30g of medicinal product
		For rheumatic and muscular pain in adults and children not less than 12
Ketorolac Trometamol
Ketotifen Fumarate
Labetalol Hydrocholoride
Lachesine Chloride
Lacidipine
Lamotrigine
Lanatoside C
Lanatoside Complex A, B and C
[F198 Lansoprazole]
Latamoxef Disodium
[F198 Lercanidipine Hydrochloride]
Levallorphan Tartrate
Levobunolol Hydrochloride
[F186 Levocabastine Hydrochloride	Equivalent of 0.05 per cent Levocabastine	(1) Nasal sprays			(1) Container or package containing not more than 10 ml of medicinal product
		For the symptomatic treatment of seasonal allergic rhinitis
		(2) Aqueous eye drops			(2) Container or package containing not more than 4 ml of medicinal product]
		For the symptomatic treatment of seasonal allergic conjunctivitis
[F229 Levocarnitine]		[F229 For dietary supplementation]
Levodopa
[F187 Levofloxacin]
Levonorgestrel	[F230 0.75mg]	[F230 for use as an emergency contraceptive in women aged 16 years and over]
Lidoflazine
Lignocaine		Non-ophthalmic use
Lignocaine Hydrochloride		Non-ophthalmic use
Lincomycin
Lincomycin Hydrochloride
Liothyronine Sodium
Lisinopril
Lithium Carbonate			Equivalent of 5mg of Lithium (MD)
			Equivalent of 15mg of Lithium (MDD)
Lithium Citrate
Lithium Succinate
Lithium Sulphate			Equivalent of 5mg of Lithium (MD)
			Equivalent of 15mg of Lithium (MDD)
Lobeline		(1) Internal	(1) 3mg (MD)
			9mg (MDD)
		(2) External
Lobeline Hydrochloride		(1) Internal	(1) Equivalent of 3mg of Lobeline (MD)
			Equivalent of 9mg of Lobeline (MDD)
		(2) External
Lobeline Sulphate		(1) Internal	(1) Equivalent of 3mg of Lobeline (MD)
			Equivalent of 9mg of Lobeline (MDD)
		(2) External
Lodoxamide Trometamol	[F231 equivalent of 0.1 per cent Lodoxamide]	[F232 For the treatment of ocular signs and symptoms of allergic conjunctivitis, in adults and in children aged 4 years and over]
Lofepramine
Lofepramine Hydrochloride
Lofexidine Hydrochloride
Lomefloxacin Hydrochloride
Lomustine
Loperamide Hydrochloride		Treatment of acute diarrhoea
Loratidine			10mg (MDD)		F233 . . .
[F199 Lornoxicam]
[F199 Losartan Potassium]
Loxapine Succinate
Lung Surfactant Porcine
Luteinising Hormone
Lymecycline
Lynoestrenol
Lypressin
Lysuride Maleate
Mafenide
Mafenide Acetate
Mafenide Hydrochloride
Mafenide Propionate	5.0 per cent	Eye drops
Magnesium Fluoride
Magnesium Metrizoate
Mandragora Autumnalis
Mannomustine Hydrochloride
Maprotiline Hydrochloride
Mebanazine
Mebendazole		For oral use in the treatment of enterobiasis in adults and in children not less than 2 years	100mg (MD)		Container or package containing not more than 800mg of Mebendazole
Mebeverine Hydrochloride		[F234 (a) For the symptomatic relief of irritable bowel syndrome	[F234 (a) 135 mg (MD) 405 mg (MDD)]
		(b) For uses other than the symptomatic relief of irritable bowel syndrome]	[F234 (b) 100 mg (MD) 300 mg (MDD)]
Mebeverine Pamoate
Mebhydrolin
Mebhydrolin Napadisylate
Mecamylamine Hydrochloride
Mecillinam
Meclofenoxate Hydrochloride
Medigoxin
Medrogestone
Medroxyprogesterone Acetate
Mefenamic Acid
Mefloquine Hydrochloride
Mefruside
Megestrol
Megestrol Acetate
Meglumine Gadopentetate
Meglumine Iodoxamate
Meglumine Ioglycamate
Meglumine Iothalamate
Meglumine Iotroxate
Meglumine Ioxaglate
[F198 Meloxicam]
Melphalan
Melphalan Hydrochloride
Menotrophin
Mepenzolate Bromide			25mg (MD)
			75mg (MDD)
Mephenesin
Mephenesin Carbamate
Mepivacaine Hydrochloride		Any use except ophthalmic use
Meptazinol Hydrochloride
Mequitazine
[F187 Mercaptamine Bitartrate]
Mercaptopurine
Mersalyl
Mersalyl Acid
Mesalazine
Mesna
Mestranol
Metaraminol Tartrate
Metergoline
Metformin Hydrochloride
Methacycline
Methacycline Calcium
Methacycline Hydrochloride
Methallenoestril
Methicillin Sodium
Methixene
Methixene Hydrochloride
Methocarbamol
Methocidin		Throat lozenges and throat pastilles
Methohexitone Sodium
Methoin
Methoserpidine
Methotrexate
Methotrexate Sodium
Methotrimeprazine
Methotrimeprazine Hydrochloride
Methotrimeprazine Maleate
Methoxamine Hydrochloride	0.25 per cent	Nasal sprays or nasal drops not containing liquid paraffin as a vehicle
Methsuximide
Methyclothiazide
Methyldopa
Methyldopate Hydrochloride
Methylephedrine Hydrochloride			30mg (MD)
			60mg (MDD)
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Sodium Succinate
Methylthiouracil
Methysergide Maleate
Metipranolol
Metirosine
Metoclopramide Hydrochloride
Metolazone
Metoprolol Fumarate
Metoprolol Succinate
Metoprolol Tartrate
Metronidazole
Metronidazole Benzoate
Metyrapone
Mexiletine Hydrochloride
Mezlocillin Sodium
Mianserin Hydrochloride
Miconazole		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Miconazole Nitrate		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Mifepristone
Miglitol
Milrinone
Milrinone Lactate
Minocycline
Minocycline Hydrochloride
Minoxidil	[F235 (1) 2.0 per cent]	[F235 (1) External
	[F235 (2) 5.0 per cent	(2) External use for the treatment of alopecia androgenetica, in men aged 18 to 65 (but not in women);]
[F183 Mirtazapine]
Misoprostol
Mitobronitol
Mitomycin
Mitozantrone Hydrochloride
Mivacurium Chloride
[F208 Mizolastine]
Moclobemide
[F187 Modafinil]
[F184 Moexipril Hydrochloride]
Molgramostim
Molindone Hydrochloride
Mometasone Furoate
Moracizine Hydrochloride
Morazone Hydrochloride
[F183 Moxonidine]
Mupirocin
Mupirocin Calcium
Mustine Hydrochloride
Nabilone
Nabumetone
Nadolol
Nafarelin Acetate
Naftidrofuryl Oxalate
Naftifine Hydrochloride
Nalbuphine Hydrochloride
Nalidixic Acid
Nalorphine Hydrobromide
Naloxone Hydrochloride
Naltrexone Hydrochloride
Naphazoline Hydrochloride	(1) 0.05 per cent	(1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle
	(2) 0.015 per cent	(2) Eye drops
Naphazoline Nitrate	0.05 per cent	Nasal sprays or nasal drops not containing liquid paraffin as a vehicle
Naproxen
Naproxen Sodium
[F187 Naratriptan Hydrochloride]
Natamycin
[F199 Nebivolol Hydrochloride]
Nedocromil Sodium	[F236 2.0 per cent]	[F236 For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis]			[F236 Container or package containing not more than 3 ml of medicinal product]
Nefazodone Hydrochloride
Nefopam Hydrochloride
Neomycin
Neomycin Oleate
Neomycin Palmitate
Neomycin Sulphate
Neomycin Undecanoate
Neostigmine Bromide
Neostigmine Methylsulphate
Netilmicin Sulphate
Nicardipine Hydrochloride
Nicergoline
[F208 Niceritrol]
Nicotinic Acid		Any use, except for the treatment of hyperlipidaemia	600mg (MDD)
Nicoumalone
Nifedipine
Nifenazone
Nikethamide
[F186 Nilutamide]
Nimodipine
Niridazole
[F199 Nisoldipine]
Nitrendipine
Nitrofurantoin
Nitrofurazone
Nizatidine		For the prevention [F237 and treatment] of the symptoms of food-related heartburn [F237 and meal-induced indigestion]	75mg (MD)
			[F238 150mg (MDD)]
			[F239 For a maximum period of 14 days]
		For use in adults and children not less than 16 years
Nomifensine Maleate
Noradrenaline
Noradrenaline Acid Tartrate
Norethisterone
Norethisterone Acetate
Norethisterone Enanthate
Norethynodrel
Norfloxacin
Norgestimate
Norgestrel
Nortriptyline Hydrochloride
Noscapine
Noscapine Hydrochloride
Novobiocin Calcium
Novobiocin Sodium
Nux Vomica Seed
Nystatin	[F240 3.0 per cent]	[F240 External			[F240 Container or package containing not more than 15g of medicinal product]
		For use in combination with Hydrocortisone of maximum strength 0.5 per cent for intertrigo
		For use in adults and children not less than 10 years]
Octacosactrin
Octreotide
Oestradiol
Oestradiol Benzoate
Oestradiol Cypionate
Oestradiol Dipropionate
Oestradiol Diundecanoate
Oestradiol Enanthate
Oestradiol Phenylpropionate
Oestradiol Undecanoate
Oestradiol Valerate
Oestriol
Oestriol Succinate
Oestrogenic Substances Conjugated
Oestrone
Ofloxacin
Olsalazine Sodium
Omeprazole
[F183 Omeprazole Magnesium]
Ondansetron Hydrochloride
Orciprenaline Sulphate
Orphenadrine Citrate
Orphenadrine Hydrochloride
Ouabain
Ovarian Gland Dried
Oxamniquine
Oxantel Embonate
Oxaprozin
Oxatomide
Oxedrine Tartrate
Oxethazaine			10mg (MD)		Container or package containing not more than 400mg of Oxethazaine
			30mg (MDD)
Oxitropium Bromide
Oxolinic Acid
Oxpentifylline
Oxprenolol Hydrochloride
Oxybuprocaine Hydrochloride		Non-ophthalmic use
Oxybutynin Hydrochloride
Oxypertine
Oxypertine Hydrochloride
Oxyphenbutazone
Oxyphencyclimine Hydrochloride
Oxyphenonium Bromide			5mg (MD)
			15mg (MDD)
Oxytetracycline
Oxytetracycline Calcium
Oxytetracycline Dihydrate
Oxytetracycline Hydrochloride
Oxytocin, natural
Oxytocin, synthetic
Pancreatin	(1) 21,000 European Pharmacopoeia units of lipase per capsule	(1) capsules
	(2) 25,000 European Pharmacopoeia units of lipase per gram	(2) powder
Pancuronium Bromide
[F198 Pantoprazole Sodium]
Papaverine		(1) By inhaler
		(2) Otherwise than by inhaler	(2) 50mg (MD)
			150mg (MDD)
Papaverine Hydrochloride		(1) By inhaler
		(2) Otherwise than by inhaler	(2) Equivalent of 50mg of Papaverine (MD)
			Equivalent of 150mg of Papaverine (MDD)
[F188 Paracetamol	(1) [F241 250mg]	(1) Non-effervescent tablets and capsules [F242 wholly or mainly] for use in children aged less than 12 years			(1) The quantity sold or supplied in one container or package shall not exceed 32 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100
	(2) 500 mg	(2) Non-effervescent tablets and capsules [F243 wholly or mainly] for use in adults and children not less than 12 years
		(3) All preparations other than non-effervescent tablets and capsules			(2) The quantity sold or supplied in one container or package shall not exceed 32 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100]
Paraldehyde
Paramethadione
Paramethasone Acetate
Parathyroid Gland
Pargyline Hydrochloride
Paroxetine Hydrochloride
Pecilocin
Penamecillin
Penbutolol Sulphate
[F198 Penciclovir]
Penicillamine
Penicillamine Hydrochloride
Pentamidine Isethionate
Penthienate Bromide			5mg (MD)
			15mg (MDD)
Pentolinium Tartrate
Perfluamine
Pergolide Mesylate
Perhexiline Maleate
Pericyazine
Perindopril
Perindopril Erbumine
Perphenazine
Phenacetin	0.1 per cent
Phenazone		External
Phenazone Salicylate
Phenbutrazate Hydrochloride
Phenelzine Sulphate
Phenethicillin Potassium
Phenformin Hydrochloride
Phenglutarimide Hydrochloride
Phenindione
[F244 Phenolphthalein.]
Phenoxybenzamine Hydrochloride
Phenoxymethylpenicillin
Phenoxymethylpenicillin Calcium
Phenoxymethylpenicillin Potassium
Phenprocoumon
Phensuximide
Phentolamine Hydrochloride
Phentolamine Mesylate
Phenylbutazone
Phenylbutazone Sodium
Phenylpropanolamine Hydrochloride		Internal
		(1) all preparations except prolonged release capsules, nasal sprays and nasal drops	(1) 25mg (MD)
			100mg (MDD)
		(2) prolonged release capsules	(2) 50mg (MD)
			100mg (MDD)
	(3) 2.0 per cent	(3) nasal sprays and nasal drops
Phenytoin
Phenytoin Sodium
Phthalylsulphathiazole
Physostigmine
Physostigmine Aminoxide Salicylate
Physostigmine Salicylate
Physostigmine Sulphate
[F186 Phytomenadione		Any use except the prevention or treatment of haemorrhagic disorders]
Picrotoxin
Pilocarpine
Pilocarpine Hydrochloride
Pilocarpine Nitrate
Pimozide
Pindolol
Pipenzolate Bromide			5mg (MD)
			15mg (MDD)
Piperacillin Sodium
Piperazine Oestrone Sulphate
Piperidolate Hydrochloride			50mg (MD)
			150mg (MDD)
Pipothiazine Palmitate
Piracetam
Pirbuterol Acetate
Pirbuterol Hydrochloride
[F245 Pirenzepine Dihydrochloride Monohydrate]
Pirenzepine Hydrochloride
Piretanide
Piroxicam	0.5 per cent	External	For maximum period of 7 days		Container or package containing not more than 30g of medicinal product
		For the relief of rheumatic pain, pain of non-serious arthritic conditions and muscular aches, pains and swellings such as strains, sprains and sports injuries
		For use in adults and children not less than 12 years
[F208 Piroxicam Beta-cyclodextrin]
Pituitary Gland (Whole Dried)		By inhaler
Pituitary Powdered (Posterior Lobe)		By inhaler
Pivampicillin
Pivampicillin Hydrochloride
Pivmecillinam
Pivmecillinam Hydrochloride
Pizotifen
Pizotifen Malate
Plicamycin
Podophyllotoxin
Podophyllum
Podophyllum Indian
Podophyllum Resin	20.0 per cent	External
		Ointment or impregnated plaster
Poldine Methylsulphate			2mg (MD)
			6mg (MDD)
Polidexide
Polyestradiol Phosphate
Polymyxin B Sulphate
Polythiazide
Poppy Capsule
Potassium Arsenite	0.0127 per cent
Potassium Bromide
Potassium Canrenoate
Potassium Clavulanate
Potassium Perchlorate
Practolol
Pralidoxime Chloride
Pralidoxime Iodide
Pralidoxime Mesylate
[F187 Pramipexole Hydrochloride]
Pravastatin Sodium
Prazosin Hydrochloride
Prednisolone
Prednisolone Acetate
Prednisolone Butylacetate
Prednisolone Hexanoate
Prednisolone Metasulphobenzoate
Prednisolone Metasulphobenzoate Sodium
Prednisolone Pivalate
Prednisolone Sodium Phosphate
Prednisolone Steaglate
Prednisone
Prednisone Acetate
Prenalterol Hydrochloride
Prenylamine Lactate
Prilocaine Hydrochloride		Non-ophthalmic use
Primidone
Probenecid
Probucol
Procainamide Hydrochloride
Procaine Hydrochloride		Non-ophthalmic use
Procaine Penicillin
Procarbazine Hydrochloride
Prochlorperazine
Prochlorperazine Edisylate
Prochlorperazine Maleate	[F202 3mg]	[F202 Buccal tablets for the treatment of nausea and vomiting in cases of previously diagnosed migraine only. For use in persons aged 18 years and over.]	[F202 12mg (MDD)]		[F202 Container or package containing not more than 8 tablets]
Prochlorperazine Mesylate
Procyclidine Hydrochloride
Progesterone
Prolactin
Proligestone
Prolintane Hydrochloride
Promazine Embonate
Promazine Hydrochloride
Propafenone
Propafenone Hydrochloride
Propanidid
Propantheline Bromide			15mg (MD)
			45mg (MDD)
[F199 Propiverine Hydrochloride]
Propofol
Propranolol Hydrochloride
Propylthiouracil
Proquazone
Protamine Sulphate
Prothionamide
Protirelin
Protriptyline Hydrochloride
Proxymetacaine Hydrochloride		Non-ophthalmic use
Pseudoephedrine Hydrochloride		Internal	(a) In the case of a prolonged release preparation
			120mg (MD)
			240mg (MDD)
			(b) in any other case 60mg (MD)
			240mg (MDD)
Pseudoephedrine Sulphate			60mg (MD)
			180mg (MDD)
Pyrantel Embonate		(a) For the treatment of enterobiosis, in adults and children not less than 12 years	(a) 750mg MDD (as a single dose)		(a) Container or package containing not more than 750mg of Pyrantel Embonate
		(b) For the treatment of enterobiosis, in children less than 12 years but not less than 6 years	(b) 500mg MDD (as a single dose)		(b) Container or package containing not more than 750mg of Pyrantel Embonate
		(c) For the treatment of enterobiosis in children less than 6 years but not less than 2 years	(c) 250mg MDD (as a single dose)		(c) Container or package containing not more than 750mg of Pyrantel Embonate
Pyrantel Tartrate
Pyrazinamide
Pyridostigmine Bromide
Pyrimethamine
[F199 Quetiapine Fumarate]
[F184 Quinagolide Hydrochloride]
Quinapril
[F245 Quinapril Hydrochloride]
Quinestradol
Quinestrol
Quinethazone
Quinidine
Quinidine Bisulphate
Quinidine Polygalacturonate
Quinidine Sulphate
Quinine			100mg (MD)
			300mg (MDD)
Quinine Bisulphate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Cinchophen			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Dihydrochloride			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Ethyl Carbonate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Glycerophosphate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Hydrobromide			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Hydrochloride			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Iodobismuthate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Phosphate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Salicylate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Sulphate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Tannate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine in combination with Urea Hydrochloride
Ramipril
[F183 Ranitidine Bismuth Citrate]
Ranitidine Hydrochloride		For the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity [F246 or the prevention of these symptoms when associated with consuming food and drink]	Equivalent to 75mg of Ranitidine (MD)
			Equivalent to 300mg of Ranitidine (MDD)
			For a maximum period of 14 days
Rauwolfia Serpentina
Rauwolfia Vomitoria
Razoxane
[F187 Reboxetine Mesilate]
Remoxipride Hydrochloride
Reproterol Hydrochloride
Rescinnamine
Reserpine
Rifabutin
Rifampicin
Rifampicin Sodium
Rifamycin
[F183 Rimexolone]
Rimiterol Hydrobromide
Risperidone
Ritodrine Hydrochloride
Rolitetracycline Nitrate
[F203 Ropinirole Hydrochloride]
Sabadilla
Salbutamol
Salbutamol Sulphate
Salcatonin
Salcatonin Acetate
Salmefamol
Salmeterol Xinafoate
Salsalate
Saralasin Acetate
Selegiline Hydrochloride
Semisodium Valproate
[F187 Sertindole]
[F183 Sertraline Hydrochloride]
Serum Gonadotrophin
[F183 Sevoflurane]
Silver Sulphadiazine
Simvastatin
Sissomicin
Sissomicin Sulphate
Snake Venoms
Sodium Acetrizoate
Sodium Aminosalicylate
Sodium Antimonylgluconate
Sodium Arsanilate
Sodium Arsenate
Sodium Arsenite	0.013 per cent
Sodium Bromide
Sodium Clodronate
Sodium Cromoglycate		(a) For nasal admistration
	(b) 2.0 per cent	(b) For the treatment of acute seasonal allergic conjunctivitis [F247 or perennial allergic conjunctivitis]			(b) Container or package containing not more than 10ml of medicinal product
		In the form of aqueous eye drops
	(c) 4.0 per cent	(c) For the treatment of acute seasonal allergic conjunctivitis			(c) Container or package containing not more than 5g of medicinal product
		In the form of an eye ointment
Sodium Ethacrynate
Sodium Fluoride	(1) 0.33 per cent	(1) Dentifrices
		(2) Other preparations for use in the prevention of dental caries
		In the form of
		(a) tablets or drops	(a) 2.2 mg (MDD)
	(b) 0.2 per cent	(b) mouth rinses other than those for daily use
	(c) 0.05 per cent	(c) mouth rinses for daily use
Sodium Fusidate
Sodium Metrizoate
Sodium Monofluorophosphate	1.14 per cent	Dentrifrice
Sodium Oxidronate
Sodium Stibogluconate
Sodium Valproate
Somatorelin Acetate
Sotalol Hydrochloride
[F184 Sparfloxacin]
Spectinomycin
Spectinomycin Hydrochloride
Spiramycin
Spiramycin Adipate
Spironolactone
Stannous Fluoride	([F248 1]) 0.62 per cent	([F248 1]) Dentifrice
	[F248 (2) 0.4 per]	[F248 (2) Dental gels for use in the prevention and treatment of dental caries and decalcification of the teeth]
Stilboestrol
Stilboestrol Dipropionate
Streptodornase		External
Streptokinase		External
Streptomycin
Streptomycin Sulphate
Strychnine
Strychnine Arsenate
Strychnine Hydrochloride
[F186 Strychnine Nitrate]
Styramate
Succinylsulphathiazole
Sucralfate
Sulbactam Sodium
Sulbenicillin
Sulbenicillin Sodium
Sulconazole Nitrate		External (except vaginal)
[F186 Sulfabenzamide]
Sulfacytine
Sulfadoxine
Sulfamerazine
Sulfamerazine Sodium
Sulfametopyrazine
Sulfamonomethoxine
Sulindac
Sulphacetamide
Sulphacetamide Sodium
Sulphadiazine
Sulphadiazine Sodium
Sulphadimethoxine
Sulphadimidine
Sulphadimidine Sodium
Sulphafurazole
Sulphafurazole Diethanolamine
Sulphaguanidine
Sulphaloxic Acid
Sulphamethizole
Sulphamethoxazole
Sulphamethoxydiazine
Sulphamethoxypyridazine
Sulphamethoxypyridazine Sodium
Sulphamoxole
Sulphanilamide
Sulphaphenazole
Sulphapyridine
Sulphapyridine Sodium
Sulphasalazine
Sulphathiazole
Sulphathiazole Sodium
Sulphaurea
Sulphinpyrazone
Sulpiride
Sultamicillin
Sultamicillin Tosylate
Sulthiame
Sumatriptan Succinate
Suprofen
Suxamethonium Bromide
Suxamethonium Chloride
Suxethonium Bromide
[F199 Tacalcitol Monohydrate]
Tacrine Hydrochloride
Talampicillin
Talampicillin Hydrochloride
Talampicillin Napsylate
Tamoxifen
Tamoxifen Citrate
[F198 Tamsulosin Hydrochloride]
[F183 Tazarotene]
Tazobactam Sodium
Teicoplanin
[F187 Temocapril Hydrochloride]
Temocillin Sodium
Tenoxicam
Terazosin Hydrochloride
Terbinafine	[F249 1.0 per cent]	[F250 External use for the treatment of tinea pedis, tinea cruris and tinea corporis. In the form of a gel]			[F251 Container or package containing not more than 30 grams of medicinal product]
[F252 Terbinafine Hydrochloride]	[F252 1.0 per cent]	([F253 1]) [F254 Preparations, other than spray solutions, for] [F252 external use for the treatment of tinea pedis and tinea cruris]			([F253 1]) [F252 Container or package containing not more than 15 g of medicinal product.]
		[F255 (2) Spray solutions for external use for the treatment of tinea corporis, tinea cruris and tinea pedis]			[F255 (2) Container containing not more than 30ml of medicinal product]
Terbutaline
Terbutaline Sulphate
Terfenadine			F256 . . .		F256 ...
Terlipressin
Terodiline Hydrochloride
[F187 Testosterone]
Tetrabenazine
Tetracosactrin
Tetracosactrin Acetate
Tetracycline
Tetracycline Hydrochloride
Tetracycline Phosphate Complex
Tetroxoprim
Thallium Acetate
Thallous Chloride
Thiabendazole
Thiambutosine
Thiethylperazine Malate
Thiethylperazine Maleate
Thiocarlide
Thioguanine
Thiopentone Sodium
Thiopropazate Hydrochloride
Thioproperazine Mesylate
Thioridazine
Thioridazine Hydrochloride
Thiosinamine
Thiotepa
Thiothixene
Thiouracil
Thymoxamine Hydrochloride
Thyroid
Thyrotrophin
Thyroxine Sodium
Tiamulin Fumarate
Tiaprofenic Acid
Tibolone
Ticarcillin Sodium
[F198 Ticlopidine Hydrochloride]
Tigloidine Hydrobromide
[F198 Tiludronate Disodium]
Timolol Maleate
Tinidazole
Tinzaparin
Tioconazole	(1) 2.0 per cent	(1) External (except vaginal)
		(2) Vaginal for treatment of vaginal candidiasis
[F184 Tizanidine Hydrochloride]
Tobramycin
Tobramycin Sulphate
Tocainide Hydrochloride
Tofenacin Hydrochloride
Tolazamide
Tolazoline Hydrochloride		External
Tolbutamide
Tolbutamide Sodium
Tolfenamic Acid
Tolmetin Sodium
[F183 Topiramate]
[F208 Torasemide]
[F198 Toremifene]
Tramadol Hydrochloride
Trandolapril
Tranexamic Acid
Tranylcypromine Sulphate
Trazodone Hydrochloride
Treosulfan
Tretinoin
Triamcinolone
Triamcinolone Acetonide	[F257 (1)] 0.1 per cent	[F257 (1)] For the treatment of common mouth ulcers			[F257 (1)] Container or package containing not more than 5g of medicinal product
		[F258 (2) In the form of a non-pressurised nasal spray, for the treatment of symptoms of seasonal allergic rhinitis in persons aged 18 years and over]	[F258 (2) 110mcg per nostril (MD)		[F258 Container or package containing not more than 3.575mg of Triamcinolone Acetonide]
			110mcg per nostril (MDD)
			For a maximum period of 3 months]
Triamcinolone Diacetate
Triamcinolone Hexacetonide
Triamterene
Tribavirin
Triclofos Sodium
Trientine Dihydrochloride
Trifluoperazine
Trifluoperazine Hydrochloride
Trifluperidol
Trifluperidol Hydrochloride
Trilostane
Trimeprazine
Trimeprazine Tartrate
Trimetaphan Camsylate
Trimetazidine
Trimetazidine Hydrochloride
Trimethoprim
Trimipramine Maleate
Trimipramine Mesylate
Tropicamide
Tropisetron Hydrochloride
Troxidone
L-Tryptophan		(1) Oral
		Dietary supplementation
		(2) External
Tubocurarine Chloride
Tulobuterol
Tulobuterol Hydrochloride
Tyrothricin		Throat lozenges or throat pastilles
Uramustine
Urea Stibamine
Urethane
Uridine 5'-triphosphate
Urofollitrophin
Urokinase
Ursodeoxychoic Acid
Vaccine: Bacillus Salmonella Typhi
Vaccine: Poliomyelitis (Oral)
[F184 Valaciclovir Hydrochloride]
Valproic Acid
[F187 Valsartan]
Vancomycin Hydrochloride
Vasopressin
Vasopressin Tannate
Vecuronium Bromide
[F184 Venlafaxine Hydrochloride]
Verapamil Hydrochloride
Veratrine
Veratrum, Green
Veratrum, White
Vidarabine
Vigabatrin
Viloxazine Hydrochloride
Vinblastine Sulphate
Vincristine Sulphate
Vindesine Sulphate
Viomycin Pantothenate
Viomycin Sulphate
Vitamin A		(1) Internal	(1) 7,500iu (2,250mcg Retinol equivalent) (MDD)
		(2) External
Vitamin A Acetate		(1) Internal	(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)
		(2) External
Vitamin A Palmitate		(1) Internal	(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)
		(2) External
Warfarin
Warfarin Sodium
Xamoterol Fumarate
Xipamide
Yohimbine Hydrochloride
[F184 Zalcitabine]
Zidovudine
Zimeldine Hydrochloride
Zolpidem Tartrate
Zomepirac Sodium
Zopiclone
Zuclopenthixol Acetate
Zuclopenthixol Decanoate
Zuclopenthixol Hydrochloride]

Textual Amendments

F183 Words in Sch. 1 inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 3(c)

F184 Words in Sch. 1 inserted (19.1.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1999 (S.I. 1999/3463), arts. 1(1), 2(c)

F185 Words in Sch. 1 inserted (24.8.2001) by The Prescription Only Medicines (Human Use) Amendment Order 2001 (S.I. 2001/2777), arts. 1(1), 3(a)

F186 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), art. 1(1), Sch.

F187 Sch. 1 entries inserted (24.8.2001) by The Prescription Only Medicines (Human Use) Amendment Order 2001 (S.I. 2001/2777), arts. 1(1), 3(g)

F188 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1997 (S.I. 1997/2044), art. 1(1), Sch. 1

F189 Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(a)

F190 Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(a)

F191 Sch. 1: entries renumbered (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(a)

F192 Words in Sch. 1 omitted (16.9.1998) by virtue of The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(b)

F193 Words in Sch. 1 inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(a)

F194 Words in Sch. 1 substituted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(a)

F195 Word in Sch. 1 substituted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(b)

F196 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(c)(ii)

F197 Words in Sch. 1 substituted (16.9.1998) by virtue ofThe Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(c)(i)

F198 Words in Sch. 1 inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(h)

F199 Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(e)

F200 Word in Sch. 1 substituted (16.9.1997) by The Prescription Only Medicines (Human Use) Amendment Order 1997 (S.I. 1997/2044), arts. 1(1), 2(a)

F201 Words in Sch. 1 revoked (31.12.2001) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 (S.I. 2001/3942), arts. 1(1), 2(a)

F202 Sch. 1 entries inserted (24.8.2001) by The Prescription Only Medicines (Human Use) Amendment Order 2001 (S.I. 2001/2777), arts. 1(1), 3(f)

F203 Sch. 1 entries inserted (31.12.2001) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 (S.I. 2001/3942), arts. 1(1), 2(e)

F204 Sch. 1 entries inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(b)

F205 Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(a)

F206 Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(d)

F207 Words in Sch. 1 substituted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(c)

F208 Words in Sch. 1 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(e)(i)

F209 Word in Sch. 1 substituted (19.1.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1999 (S.I. 1999/3463), arts. 1(1), 2(a)

F210 Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(e)

F211 Words in Sch. 1 inserted (24.8.2001) by The Prescription Only Medicines (Human Use) Amendment Order 2001 (S.I. 2001/2777), arts. 1(1), 3(b)

F212 Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(f)(i)

F213 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(f)(ii)

F214 Words in Sch. 1 omitted (16.9.1998) by virtue of The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(f)(iii)

F215 Words in Sch. 1 inserted (31.12.2001) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 (S.I. 2001/3942), arts. 1(1), 2(b)(i)

F216 Words in Sch. 1 inserted (31.12.2001) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 (S.I. 2001/3942), arts. 1(1), 2(b)(ii)

F217 Words in Sch. 1 inserted (31.12.2001) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 (S.I. 2001/3942), arts. 1(1), 2(b)(iii)

F218 Words in Sch. 1 inserted (31.12.2001) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 (S.I. 2001/3942), arts. 1(1), 2(b)(iv)

F219 Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(c)

F220 Sch. 1: entries renumbered (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(c)

F221 Words in Sch. 1 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(a)

F222 Words in Sch. 1 inserted (24.8.2001) by The Prescription Only Medicines (Human Use) Amendment Order 2001 (S.I. 2001/2777), arts. 1(1), 3(c)

F223 Words in Sch. 1 inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 3(a)

F224 Words in Sch. 1 substituted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(d)

F225 Word in Sch. 1 inserted (13.8.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(e)(ii)

F226 Word in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(g)(ii)

F227 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(g)(i)

F228 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(g)(iii)

F229 Words in Sch. 1 inserted (19.1.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1999 (S.I. 1999/3463), arts. 1(1), 2(b)

F230 Sch. 1 entries inserted (1.1.2001) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2000 (S.I. 2000/3231), arts. 1(1), 2

F231 Words in Sch. 1 inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(e)(i)

F232 Words in Sch. 1 inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(e)(ii)

F233 Words in Sch. 1 revoked (31.12.2001) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 (S.I. 2001/3942), arts. 1(1), 2(c)

F234 Words in Sch. 1 substituted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(b)

F235 Words in Sch. 1 substituted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(b)

F236 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(h)

F237 Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(c)(i)

F238 Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(c)(ii)

F239 Words in Sch. 1 substituted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(c)(iii)

F240 Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(d)

F241 Words in Sch. 1 substituted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(f)(i)

F242 Words in Sch. 1 inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(f)(ii)

F243 Words in Sch. 1 inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(f)(iii)

F244 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(d)(ii)

F245 Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(d)(i)

F246 Words in Sch. 1 added (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(c)

F247 Words in Sch. 1 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(d)

F248 Sch. 1: entries renumbered (24.8.2001) by The Prescription Only Medicines (Human Use) Amendment Order 2001 (S.I. 2001/2777), arts. 1(1), 3(d)

F249 Words in Sch. 1 inserted (31.12.2001) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 (S.I. 2001/3942), arts. 1(1), 2(d)(i)

F250 Words in Sch. 1 inserted (31.12.2001) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 (S.I. 2001/3942), arts. 1(1), 2(d)(ii)

F251 Words in Sch. 1 inserted (31.12.2001) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 (S.I. 2001/3942), arts. 1(1), 2(d)(iii)

F252 Words in Sch. 1 inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 3(b)

F253 Sch. 1: entries renumbered (24.8.2001) by The Prescription Only Medicines (Human Use) Amendment Order 2001 (S.I. 2001/2777), arts. 1(1), 3(e)

F254 Words in Sch. 1 inserted (24.8.2001) by The Prescription Only Medicines (Human Use) Amendment Order 2001 (S.I. 2001/2777), arts. 1(1), 3(e)

F255 Sch. 1 entries inserted (24.8.2001) by The Prescription Only Medicines (Human Use) Amendment Order 2001 (S.I. 2001/2777), arts. 1(1), 3(e)

F256 Words in Sch. 1 omitted (16.9.1997) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 1997 (S.I. 1997/2044), arts. 1(1), 2(b)

F257 Sch. 1 entries re-numbered (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(g)

F258 Sch. 1 entries inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(g)

Article 10(1)

[F259 SCHEDULE 2 SUBSTANCES WHICH MAY BE EXCLUDED FROM THE CLASS OF PRESCRIPTION ONLY MEDICINES AT HIGH DILUTION

Textual Amendments

F259 Sch. 2 substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 12

• Codeine and its salts

• Dihydrocodeine and its salts

• Ethylmorphine and its salts

• Morphine and its salts

• Medicinal Opium

• Pholcodine and its salts]

Article 2(b)

SCHEDULE 3 DESCRIPTIONS AND CLASSES OF PRESCRIPTION ONLY MEDICINES IN RELATION TO WHICH [F260 community practitioner nurse prescribers] ARE APPROPRIATE PRACTITIONERS

Textual Amendments

F260 Words in Sch. 3 heading substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 13

• [F261 Co-danthramer Capsules NPF]

• [F261 Co-danthramer Capsules, Strong NPF]

• Co-danthramer-Oral Suspension NPF

• Co-danthramer-Oral Suspension Strong NPF

• Co-danthrusate Capsules

• [F261 Co-danthrusate Oral Suspension NPF]

• Mebendazole Tablets NPF

• Mebendazole Oral Suspension NPF

• Miconazole Oral Gel NPF

• Nystatin Oral Suspension

• Nystatin Pastilles NPF

• Streptokinase and Streptodornase Topical Powder NPF

• [F262 Water for Injections]

Textual Amendments

F261 Words in Sch. 3 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 4

F262 Words in Sch. 3 inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 14

Article 3A

F263 SCHEDULE 3A CONTROLLED DRUGS WHICH MAY BE PRESCRIBED, ADMINISTERED OR DIRECTED FOR ADMINISTRATION BY NURSE INDEPENDENT PRESCRIBERS AND CONDITIONS FOR SUCH PRESCRIPTION OR ADMINISTRATION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F263 Sch. 3A omitted (1.4.2008) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2008 (S.I. 2008/464), arts. 1(1), 10

Regulation 3B(3)(a)(iii)

[F264 SCHEDULE 3B PARTICULARS FOR CLINICAL MANAGEMENT PLANS

Textual Amendments

F264 Sch. 3B inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 16

A clinical management plan shall contain the following particulars—

(a) the name of the patient to whom the plan relates;

(b) the illnesses or conditions which may be treated by the supplementary prescriber;

(c) the date on which the plan is to take effect and when it is to be reviewed by the doctor or dentist who is a party to the plan;

(d) reference to the class or description of medicinal product which may be prescribed or administered under the plan;

(e) any restrictions or limitations as to the strength or dose of any product which may be prescribed or administered under the plan, and any period of administration or use of any medicinal product which may be prescribed or administered under the plan;

(f) relevant warnings about the known sensitivities of the patient to, or known difficulties of the patient with, particular medicinal products;

(g) the arrangements for notification of—

(i) suspected or known adverse reactions to any medicinal product which may be prescribed or administered under the plan, and

(ii) suspected or known adverse reactions to any other medicinal product taken at the same time as any medicinal product prescribed or administered under the plan; and

(h) the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the doctor or dentist who is a party to the plan.]

Article 8(4)(c)

SCHEDULE 4 SUBSTANCES NOT TO BE CONTAINED IN A PRESCRIPTION ONLY MEDICINE SOLD OR SUPPLIED UNDER THE EXEMPTION CONFERRED BY ARTICLE 8(3)

• Ammonium Bromide

• Calcium Bromide

• Calcium Bromidolactobionate

• Embutramide

• Fencamfamin Hydrochloride

• Fluanisone

• Hexobarbitone

• Hexobarbitone Sodium

• Hydrobromic Acid

• Meclofenoxate Hydrochloride

• Methohexitone Sodium

• Pemoline

• Piracetam

• Potassium Bromide

• Prolintane Hydrochloride

• Sodium Bromide

• Strychnine Hydrochloride

• Tacrine Hydrochloride

• Thiopentone Sodium

Article 11(1)(a)

SCHEDULE 5 EXEMPTION FOR CERTAIN PERSONS FROM SECTION 58(2) OF THE ACT

PART I EXEMPTION FROM RESTRICTIONS ON SALE OR SUPPLY

Column 1	Column 2	Column 3
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
1. Persons selling or supplying prescription only medicines to universities, other institutions concerned with higher education or institutions concerned with research.	1. All prescription only medicines	1. The sale or supply shall be– (a) subject to the presentation of an order signed by the principal of the institution concerned with education or research or the appropriate head of department in charge of a specified course of research stating– (i) the name of the institution for which the prescription only medicine is required, (ii) the purpose for which the prescription only medicine is required, and (iii) the total quantity required, and (b) for the purposes of the education or research with which the institution is concerned.
2. Persons selling or supplying prescription only medicines to any of the following– (1) a public analyst appointed under section 27 of the Food Safety Act 1990(15) or article 36 of the Food (Northern Ireland) Order 1989(16), (2) an authorized officer within the meaning of section 5(6) of the Food Safety Act 1990, (3) a sampling officer within the meaning of article 38(1) of the Food (Northern Ireland) Order 1989, (4) a person duly authorized by an enforcement authority under sections 111 and 112, (5) a sampling officer within the meaning of Schedule 3 to the Act.	2. All prescription only medicines.	2. The sale or supply shall be subject to the presentation of an order signed by or on behalf of any person listed in column 1 of this paragraph stating the status of the person signing it and the amount of prescription only medicine required, and shall be only in connection with the exercise by those persons of their statutory functions.
3. Persons selling or supplying prescription only medicines to any person employed or engaged in connection with a scheme for testing the quality and checking the amount of the drugs and appliances supplied under the National Health Service Act 1977(17), the National Health Service (Scotland) Act 1978(18) and the Health and Personal Social Services (Northern Ireland) Order 1972(19), or under any subordinate legislation made under those Acts or that Order.	3. All prescription only medicines.	3. The sale or supply shall be– (a) subject to the presentation of an order signed by or on behalf of the person so employed or engaged stating the status of the person signing it and the amount of prescription only medicine required, and (b) for the purposes of a scheme referred to in column 1 in this paragraph.
4. Registered midwives.	4. Prescription only medicines containing any of the following substances– Chloral hydrate Ergometrine maleate Pentazocine hydrochloride [F265 Phytomenadione] Triclofos sodium.	4. The sale or supply shall be only in the course of their professional practice and in the case of Ergometrine maleate only when contained in a medicinal product which is not for parenteral administration.
5. Persons lawfully conducting a retail pharmacy business within the meaning of section 69.	5. Prescription only medicines which are not for parenteral administration and which– (a) are eyes drops and are prescription only medicines by reason only that they contain not more than 0.5 per cent Chloramphenicol, or (b) are eye ointments and are prescription only medicines by reason only that they contain not more than 1.0 per cent Chloramphenicol, or (c) are prescription only medicines by reason only that they contain any of the following substances: F266 ... F266 ... F266 ... Cyclopentolate hydrochloride [F267 Fusidic Acid] F268 ... F268 ... F268 ... F268 ... F269 ... F268 ... F268 ... Tropicamide.	5. The sale or supply shall be subject to the presentation of an order signed by a [F270 registered optometrist].
6. [F271 Registered optometrists]	6. Prescription only medicines listed in column 2 of paragraph 5.	6. The sale or supply shall be only– (a) in the course of their professional practice and (b) in an emergency.
[F272 6A Persons lawfully conducting a retail pharmacy business within the meaning of section 69.	Homotropine hydrobromide Ketotifen Levocabastine Lodoxamide Nedocromil sodium Olopatadine Pilocarpine hydrochloride [F273 Pilocarpine nitrate] Polymyxin B/bacitracin Polymyxin B/trimethoprim Sodium cromoglycate.	The sale or supply shall be subject to the presentation of an order signed by an additional supply optometrist.
6B Additional supply optometrists.	Prescription only medicines specified in column 2 of paragraph 6A.	The sale or supply shall be only— (a) in the course of their professional practice, and (b) in an emergency.]
7. Persons selling or supplying prescription only medicines to the British Standards Institution.	7. All prescription only medicines.	7. The sale or supply shall be– (a) subject to the presentation of an order signed on behalf of the British Standards Institution stating the status of the person signing it and the amount of the prescription only medicine required, and (b) only for the purpose of testing containers of medicinal products or determining the standards for such containers.
8. Holders of marketing authorizations, product licences or manufacturer’s licences.	8. Prescription only medicines referred to in the authorizations or licences.	8. The sale or supply shall be only– (a) to a pharmacist, (b) so as to enable that pharmacist to prepare an entry relating to the prescription only medicine in question in a tablet or capsule identification guide or similar publication, and (c) of no greater quantity than is reasonably necessary for that purpose.
9. Pharmacists selling or supplying to persons to whom cyanide salts may be sold by virtue of section 3 (regulation of poisons) or section 4 (exclusion of sales by wholesale and certain other sales) of the Poisons Act 1972(20) or by virtue of article 5 (prohibitions and regulations with respect to sale of poisons) or article 6 (exemption with respect to certain sales) of the Poisons (Northern Ireland) Order 1976(21).	9. Amyl nitrite.	9. The sale or supply shall only be so far as is necessary to enable an antidote to be available to persons at risk of cyanide poisoning.
[F274 [F275 10.   Registered chiropodists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2.]	10.   The following prescription only medicines— (a) Co-dydramol 10/500 tablets; (b) Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight; (c) Amorolfine hydrochloride lacquer where the maximum strength of the Amorolfine in the lacquer does not exceed 5 per cent by weight in volume; F276 ... (d) Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight [F277 in weight; and] [F278 (e) Amoxicillin; (f) Erythromycin; (g) Flucoxacillin; (h) Tioconazole 28%; and (i) Silver Sulfadiazine.]	10.   The sale or supply shall be only in the course of their professional practice and (a) in the case of Co-dydramol 10/500 tablets the quantity sold or supplied to a person at any one time shall not exceed the amount sufficient for 3 days' treatment to a maximum of 24 tablets.]

Textual Amendments

F265 Word in Sch. 5 Pt. 1 para. 4 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 4(a)

F266 Words in Sch. 5 Pt. 1 para. 5 omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 8(a)

F267 Words in Sch. 5 Pt. 1 para. 5 inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 8(b)

F268 Words in Sch. 5 Pt. 1 omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 8(c)

F269 Words in Sch. 5 Pt. 1 para. 5 omitted (30.6.2005) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 7(1)(a)

F270 Words in Order substituted (30.6.2005 as notified in the London Gazette dated 3.6.2005) by The Opticians Act 1989 (Amendment) Order 2005 (S.I. 2005/848), Sch. 1 para. 27(b)

F271 Words in Order substituted (30.6.2005 as notified in the London Gazette dated 3.6.2005) by The Opticians Act 1989 (Amendment) Order 2005 (S.I. 2005/848), Sch. 1 para. 27(b)

F272 Sch. 5 Pt. 1 paras. 6A, 6B inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 7(1)(b)

F273 Words in Sch. 5 Pt. 1 Table inserted (6.1.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) (No. 2) Order 2005 (S.I. 2005/3324), arts. 1(1), 3

F274 Words in Sch. 5 Pt. 1 para. 10 substituted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 4(2)(a)

F275 Sch. 5 Pt. 1 para. 10 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), art. 1, Sch.

F276 Word in Sch. 5 Pt. 1 para. 10 omitted (17.11.2006) by virtue of The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 4(2)(b)(i)

F277 Words in Sch. 5 Pt. 1 para. 10 substituted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 4(2)(b)(ii)

F278 Words in Sch. 5 Pt. 1 para. 10 added (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 4(2)(b)(iii)

Article 11(1)(b)

PART II EXEMPTIONS FROM THE RESTRICTION ON SUPPLY

Column 1	Column 2	Column 3
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
1. Royal National Lifeboat Institution and certified first aiders of the Institution.	1. All prescription only medicines.	1. The supply shall be only so far as is necessary for the the treatment of sick or injured persons in the exercise of the functions of the Institution.
2. The owner or the master of a ship which does not carry a doctor on board as part of her complement.	2. All prescription only medicines.	2. The supply shall be only so far as is necessary for the treatment of persons on the ship.
3. Persons authorized by licences granted under regulation 5 of the Misuse of Drugs Regulations to supply a controlled drug.	3. Such prescription only medicines, being controlled drugs, as are specified in the licence.	3. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.
[F279 3A. Persons employed or engaged in the provision of lawful drug treatment services.	3A. Ampoules of sterile water for injection containing not more than 2 ml of sterile water.	3A. The supply shall be only in the course of provision of lawful drug treatment services.]
4. Persons requiring prescription only medicines for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees.	4. Such prescription only medicines as may be specified in the relevant enactment.	4. The supply shall be– (a) for the purpose of enabling them to comply with any requirements made by or in pursuance of any such enactment, and (b) subject to such conditions and in such circumstances as may be specified in the relevant enactment.
5. Persons operating an occupational health scheme.	5. Prescription only medicines sold or supplied to a person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.	5. — (1) The supply shall be in the course of an occupational health scheme. (2) The individual supplying the prescription only medicine, if not a doctor, shall be a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of the occupational health scheme.
6. The operator or commander of an aircraft.	6. Prescription only medicines which are not for parenteral administration and which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.	6. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons employed as qualified first-aid personnel on offshore installations.	7. All prescription only medicines.	7. The supply shall be only so far as is necessary for the treatment of persons on the installation.
[F280 8. Persons who hold a certificate in first aid from the Mountain Rescue Council of England and Wales, or from the Northern Ireland Mountain Rescue Co-ordinating Committee.	8 Prescription only medicines supplied to a person specified in column 1 in response to an order in writing signed by a doctor.	8 The supply shall be only so far as is necessary for the treatment of sick or injured persons in the course of providing mountain rescue services.]

Textual Amendments

F279 Sch. 5 Pt. 2 para. 3A inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 7(2)

F280 Sch. 5 Pt. 2 para. 8 inserted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 4(3)

Article 11(2)

PART III EXEMPTIONS FROM RESTRICTION ON ADMINISTRATION Column 1

Column 1	Column 2	Column 3
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
[F281 1. Registered chiropodists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2..]	1. Prescription only medicines for parenteral administration that contain,as the sole active ingredient, not more than one of the following substances– [F282 Adrenaline] [F283 Bupivacaine hydrochloride Bupivacaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of bupivacaine hydrochloride [F282 Levobupivacaine hydrochloride] Lignocaine hydrochloride Lignocaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of lignocaine hydrochloride [F284 Mepivacaine hydrochloride] [F282 Methylprednisolone] Prilocaine hydrochloride.] [F282 Ropivacaine hydrochloride]	1. The administration shall be only in the course of their professional practice.
2. Registered midwives.	2. Prescription only medicines for parenteral administration containing any of the following substances but no other substance specified in column 1 of Schedule 1 to this Order– [F285 Diamorphine] Ergometrine maleate Lignocaine Lignocaine hydrochloride [F285 Morphine] Naloxone hydrochloride Oxytocins, natural and synthetic Pentazocine lactate Pethidine hydrochloride Phytomenadione Promazine hydrochloride.	2. The administration shall be only in the course of their professional practice and in the case of Promazine hydrochloride, Lignocaine and Lignocaine hydrochloride shall be only while attending on a woman in childbirth.
3. Persons who are authorized as members of a group by a group authority granted under regulations 8(3) or 9(3) of the Misuse of Drugs Regulations to supply a controlled drug by way of administration only.	3. Prescription only medicines that are specified in the group authority.	3. The administration shall be subject to such conditions and in such circumstances and to such extent as may be specified in the group authority.
4. The owner or master of a ship which does not carry a doctor on board as part of her complement.	4. All prescription only medicines that are for parenteral administration.	4. The administration shall be only so far as is necessary for the treatment of persons on the ship.
5. Persons operating an occupational health scheme.	5. Prescription only medicines for parenteral administration sold or supplied to the person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.	5. — (1) The administration shall be in the course of an occupational health scheme. (2) The individual administering the prescription only medicine, if neither a doctor nor acting in accordance with the directions of a doctor, shall be a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of the occupational health scheme.
6. The operator or commander of an aircraft.	6. Prescription only medicines for parenteral administration which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.	6. The administration shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons who are, and at 11th February 1982 were, persons customarily administering medicinal products to human beings by parenteral administration in the course of a business in the field of osteopathy, naturopathy, acupuncture or other similar field except chiropody.	7. Medicinal products that are prescription only medicines by reason only that they fall within the class specified in article 3(c) (products for parenteral administration).	7. The person administering the prescription only medicine shall have been requested by or on behalf of the person to whom it is administered and in that person’s presence to use his own judgement as to the treatment required.
8. Persons employed as qualified first-aid personnel on offshore installations.	8. All prescription only medicines that are for parenteral administration.	8. The administration shall be only so far as is necessary for the treatment of persons on the installation.
9. Persons who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State [F286 or persons who are [F287 registered] paramedics].	9. The following prescription only medicines for parenteral administration– (a) Diazepam 5 mg per ml emulsion for injection; (b) Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion; (bb) [F288 medicines containing the substances Ergometrine Maleate 500mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient] (d) prescription only medicines containing one or more of the following substances, but no active ingredient– Adrenaline Acid Tartrate [F289 Amiodarone] Anhydrous Glucose [F290 Benzylpenicillin] [F291 Bretylium Tosylate] Compound Sodium Lactate Intravenous Infusion (Hartmann’s Solution) Ergometrine Maleate [F290 Frusemide] Glucose Heparin Sodium Lignocaine Hydrochloride [F290 Metoclopramide] [F290 Morphine Sulphate] Nalbuphine Hydrochloride Naloxone Hydrochloride Polygeline [F292 Reteplase ] Sodium Bicarbonate Sodium Chloride [F290 Streptokinase] [F292 Tenecteplase.]	9. The administration shall be only for the immediate, necessary treatment of sick or injured persons and in the case of a prescription only medicine containing Heparin Sodium shall be only for the purpose of cannula flushing.

Textual Amendments

F281 Words in Sch. 5 Pt. 3 para. 1 substituted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 4(4)(a)

F282 Words in Sch. 5 Pt. 3 para. 1 inserted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 4(4)(b)

F283 Words in Sch. 5 Pt. 3 substituted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 5(2)

F284 Words in Sch. 5 Pt. 3 para. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 4(b)

F285 Words in Sch. 5 Pt. 3 para. 2 inserted (31.1.2004) by The Prescription Only Medicines (Human Use) Amendment Order 2004 (S.I. 2004/2), arts. 1(1), 4

F286 Words in Sch. 5 Pt. 3 para. 9 added (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 5(a)

F287 Word in Sch. 5 Pt. 3 para. 9 substituted for words (9.7.2003) by The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(3)(b)(ii)

F288 Words in Sch. 5 Pt. 3 para. 9 inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 5(b)

F289 Word in Sch. 5 Pt. 3 para. 9 inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 6

F290 Words in Sch. 5 Pt. 3 para. 9 inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 5(c)

F291 Words in Sch. 5 Pt. 3 para. 9 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 3

F292 Words in Sch. 5 Pt. 3 para. 9 inserted (18.5.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2004 (S.I. 2004/1189), arts. 1(1), 4

Article 16(1)

SCHEDULE 6 ORDERS REVOKED

Column 1	Column 2
Orders	References
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Order 1983	S.I. 1983/1212
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1984	S.I. 1984/756
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1986	S.I. 1986/586
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1987	S.I. 1987/674
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1987	S.I. 1987/1250
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1988	S.I. 1988/2017
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1991	S.I. 1991/962
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1992	S.I. 1992/1534
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1992	S.I. 1992/2937
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1993	S.I. 1993/1890
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1993	S.I. 1993/3256
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1994	S.I. 1994/558
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1994	S.I. 1994/3016
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 3) Order 1994	S.I. 1994/3050
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1995	S.I. 1995/1384
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1995	S.I. 1995/3174
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1996	S.I. 1996/1514
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1996	S.I. 1996/3193

Articles 12A to 12C

[F293 SCHEDULE 7

Textual Amendments

F293 Sch. 7 inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(e)

PART I PARTICULARS TO BE INCLUDED IN A PATIENT GROUP DIRECTION

(a) the period during which the Direction shall have effect;

(b) the description or class of prescription only medicine to which the Direction relates;

(c) whether there are any restrictions on the quantity of medicine which may be [F294 sold or] supplied on any one occasion, and, if so, what restrictions;

(d) the clinical situations which prescription only medicines of that description or class may be used to treat;

(e) the clinical criteria under which a person shall be eligible for treatment;

(f) whether any class of person is excluded from treatment under the Direction and, if so, what class of person;

(g) whether there are circumstances in which further advice should be sought from a doctor or dentist and, if so, what circumstances;

(h) the pharmaceutical form or forms in which prescription only medicines of that description or class are to be administered;

(i) the strength, or maximum strength, at which prescription only medicines of that description or class are to be administered;

(j) the applicable dosage or maximum dosage;

(k) the route of administration;

(l) the frequency of administration;

(m) any minimum or maximum period of administration applicable to prescription only medicines of that description or class;

(n) whether there are any relevant warnings to note, and, if so, what warnings;

(o) whether there is any follow up action to be taken in any circumstances, and, if so, what action and in what circumstances;

(p) arrangements for referral for medical advice;

(q) details of the records to be kept of the supply, or the administration, of medicines under the Direction.

Textual Amendments

F294 Words in Sch. 7 Pt. 1 inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 5

PART II PERSONS ON WHOSE BEHALF A PATIENT GROUP DIRECTION MUST BE SIGNED

Column 1	Column 2
Class of person by whom a prescription only medicine is supplied or administered	Person on whose behalf the Direction must be signed
Common Services Agency	The Agency
[F295 Strategic Health Authority]	[F295 The Strategic Health Authority]
Health Authority	The Health Authority
Special Health Authority	The Special Health Authority
NHS trust [F296 or NHS foundation trust]	The trust
Primary Care Trust	The Trust
A person who supplies or administers a prescription only medicine pursuant to an arrangement made with the Common Services Agency, a Health Authority, a Special Health Authority, an NHS trust, [F297 , an NHS foundation trust] or a Primary Care Trust	The Common Services Agency, where the arrangement has been made with the Agency; or the Health Authority, Special Health Authority, NHS trust [F298 or NHS foundation trust] or Primary Care Trust with which the arrangement has been made

Textual Amendments

F295 Words in Sch. 7 Pt. 2 inserted (1.10.2002) by The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2002 (S.I. 2002/2469), reg. 1, Sch. 1 para. 73(4)

F296 Words in Sch. 7 Pt. 2 inserted (1.4.2004) by The Health and Social Care (Community Health and Standards) Act 2003 (Supplementary and Consequential Provision) (NHS Foundation Trusts) Order 2004 (S.I. 2004/696), arts. 1(1)(b), 3(2), Sch. 2

F297 Words in Sch. 7 Pt. 2 inserted (1.4.2004) by The Health and Social Care (Community Health and Standards) Act 2003 (Supplementary and Consequential Provision) (NHS Foundation Trusts) Order 2004 (S.I. 2004/696), arts. 1(1)(b), 3(4), Sch. 4

F298 Words in Sch. 7 Pt. 2 inserted (1.4.2004) by The Health and Social Care (Community Health and Standards) Act 2003 (Supplementary and Consequential Provision) (NHS Foundation Trusts) Order 2004 (S.I. 2004/696), arts. 1(1)(b), 3(3), Sch. 3

[F299 PART IIA PERSONS BY WHOM OR ON WHOSE BEHALF A PATIENT GROUP DIRECTION USED IN THE PROVISION OF HEALTH CARE BY OR ON BEHALF OF THE POLICE, THE PRISON SERVICES OR THE ARMED FORCES MUST BE SIGNED

Textual Amendments

F299 Sch. 7 Pt. 2A inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 17

Column 1 Force or service by whom or on whose behalf the health care is provided	Column 2 Person by whom or on whose behalf the Direction must be signed
A police force in England or Wales	The chief officer of police for that police force (within the meaning of the Police Act 1996)
A police force in Scotland	The chief constable of that police force (within the meaning of the Police (Scotland) Act 1997)
The Police Service of Northern Ireland	The Chief Constable of the Police Service of Northern Ireland
The prison service in England and Wales	The governor of the prison in relation to which the health care in question is being provided
The prison service in Scotland	The Scottish Prison Service Management Board
The prison service in Northern Ireland	The Northern Ireland Prison Service Management Board
Her Majesty’s Forces	(i) the Surgeon General, (ii) a Medical Director General, or (iii) a chief executive of an executive agency of the Ministry of Defence]

PART III CLASSES OF INDIVIDUAL [F300 BY WHOM PRESCRIPTION ONLY MEDICINES MAY BE SUPPLIED OR ADMINISTERED]

Textual Amendments

F300 Words in Sch. 7 Pt. 3 heading substituted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 3(2)

• [F301 Registered paramedics or individuals who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State.]

• Pharmacists.

• F302 ...

• Registered midwives.

• Registered nurses.

• [F303 Registered optometrists]

• [F304 Registered] chiropodists.

• [F305 Registered orthoptists.

• Registered physiotherapists.

• Registered radiographers.]

• [F306 “Registered dietitians.”;]

• [F306 “Registered occupational therapists.”;]

• [F306 “Registered orthotists and prosthetists.”; and]

• [F306 “Registered speech and language therapists.”]]

Textual Amendments

F301 Words in Sch. 7 Pt. 3 substituted (9.7.2003) by The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(4)(a)

F302 Words in Sch. 7 Pt. 3 omitted (1.8.2004) by virtue of The Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004 (S.I. 2004/1771), art. 1(1), Sch. para. 39(b)

F303 Words in Order substituted (30.6.2005 as notified in the London Gazette dated 3.6.2005) by The Opticians Act 1989 (Amendment) Order 2005 (S.I. 2005/848), Sch. 1 para. 27(b)

F304 Word in Sch. 7 Pt. 3 substituted (9.7.2003) by The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(4)(b)

F305 Words in Sch. 7 Pt. 3 substituted (9.7.2003) by The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(4)(c)

F306 Words in Sch. 7 Pt. 3 added (18.5.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2004 (S.I. 2004/1189), arts. 1(1), 5

Explanatory Note

(This note is not part of the Order)

This Order consolidates with amendments the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 as amended. That Order and the Orders amending it (“the 1983 Order as amended”) are revoked by article 16 and Schedule 6.

This Order specifies the descriptions and classes of prescription only medicines (i.e. medicinal products which, subject to exemptions, may be sold or supplied by retail only in accordance with a prescription given by an appropriate practitioner and which may be administered only by or in accordance with the directions of such a practitioner). Many medicinal products are included in a class of such medicines by reason of the substances contained in them (seeSchedule 1) but others are included because of other criteria, such as their method of administration (seearticle 3). In many cases the provisions of the Act apply subject to exemptions (seearticles 4 and 5 to 13 and Schedule 1).

The principal amendments relate to those medicines in respect of which marketing authorizations have been granted by the European Community. They include as prescription only medicines those medicines in respect of which such an authorization has been granted which classifies a medicine as being subject to medical prescription (article 3(f)). They exclude from the class of prescription only medicines those medicines in respect of which such an authorization provides for supply which is not subject to medical prescription (article 6(3)).

The differences between this Order and the 1983 Order as amended are in the main technical changes concerning the location of provisions such as the division of material in Schedule 1 to the 1983 Order as amended between the new Schedules 1 and 2. But within the new Schedule 1 there are changes which relate to–

(a) the deletion from Column 1 of substances which are no longer used in those medicinal products which are on the market;

(b) the use of current names for the substances which are specified in that Column where their names have changed;

(c) the incorporation in that Schedule of provisions from article 4 of, and Part IV of Schedule 1 to, the 1983 Order as amended so that they may be found more easily;

(d) a change in the legal base for the entries in Columns 2 to 4 so that those entries now form the criteria for exemptions from the sale or supply requirements of section 58(2) of the Medicines Act 1968 instead of the criteria for excluding medicinal products from the class of prescription only medicines (see alsoarticle 5);

(e) the introduction of a fifth Column which specifies the maximum pack sizes to which exemptions apply.

As this order will impose no additional costs to business a compliance cost assessment has not been prepared.

(1)

1968 c. 67. Section 58 has been amended by the Prescription by Nurses Etc. Act 1992 (c. 28), section 1. The expression “the appropriate Ministers” is defined in section 1(2) of the Medicines Act 1968.

(2)

In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); in the case of the Secretary of State concerned with Agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272) and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).

(3)

1971 c. 38.

(4)

1977 c. 49.

(5)

1978 c. 29.

(6)

S.I. 1972/1265 (N.I. 14).

(7)

1995 c. 21.

(8)

S.I. 1985/2066.

(9)

SR 1986 No. 52.

(10)

1971 c. 61; section 1 was substituted by section 24 of the Oil and Gas (Enterprise) Act 1982 (c. 23).

(11)

1964 c. 29.

(12)

S.I. 1980/1923, amended by S.I. 1997/1831.

(13)

S.I. 1989/1852.

(14)

See S.I. 1979/382 amended by S.I. 1980/263 and S.I. 1989/1124.

(15)

1990 c. 16.

(16)

S.I. 1989/846 (N.I. 6).

(17)

1977 c. 49.

(18)

1978 c. 29.

(19)

S.I. 1972/1265 (N.I. 14).

(20)

1972 c. 66.

(21)

S.I. 1976/1214 (N.I. 23).