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;

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

[F1 “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;

[F2 “clinical trial” has the meaning given by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2003;]

F3 ...

[F4 “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;]

[F4 “Community marketing authorization” means a marketing authorization granted by the European Community under Council Regulation (EEC) No. 2309/93;]

“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;

[F5 “district nurse/health visitor prescriber” means a first level nurse, or a registered midwife, against whose name in the professional register there is an annotation that he is qualified to order drugs, medicines and appliances from the Nurse Prescriber’s Formulary for District Nurses and Health Visitors Appendix in the current edition of the British National Formulary];

“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;

[F6 “Extended Formulary” means the Nurse Prescribers’ Extended Formulary Appendix in the current edition of the British National Formulary;]

[F6 “extended formulary nurse prescriber” means a person—

(a)

[F7 who is a first level nurse [F8 or registered midwife], and]

(b)

against whose name is recorded in [F9 the professional register] an annotation signifying that he is qualified to order drugs, medicines and appliances from the Extended Formulary;]

“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;

[F10 “first level nurse” means a person registered in Sub-Part 1 of the Nurses' Part of the professional register;]

[F4 “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 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;]

[F11 “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 [F12 , supplementary prescriber] [F13 , a district nurse/health visitor prescriber or an extended formulary nurse 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);

[F14 “health record” has the meaning given by section 68(2) of the Data Protection Act 1998(6);]

[F4 “homoeopathic certificate of registration” means a certificate of registration for the purposes of the Medicines (Homoeopathic Medicinal Products For Human Use) Regulations 1994;]

[F15 “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 2001;]

[F15 “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 2001;]

[F15 “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 2001;]

“inhaler” does not include an aerosol;

[F4 “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;

“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 Act, but does not include–

(a)

a medicinal product which is a veterinary drug as defined in section 132(1) of the Act or

(b)

an article or substance in respect of which section 58 has such effect where that article or substance is only to be administered to animals;

“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);

[F4 “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;]

[F16 “NHS foundation trust” has the same meaning as in section 1(1) of the Health and Social Care (Community Health and Standards) Act 2003;]

[F17 “nursing home” has the meaning given by article 16 of the Registered Homes (Northern Ireland) Order 1992;]

“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);

“operator”, in relation to an aircraft, means the person for the time being having the management of the aircraft;

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

[F4 “Patient Group Direction” means—

(a)

in connection with the supply of a prescription only medicine as referred to in article 12A(2), [F18 12B, 12C, 12D or 12E] , a written direction relating to the 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 supply and administration, or to administration, to persons generally (subject to any exclusions which may be set out in the Direction);]

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

[F4 “Primary Care Trust” has the same meaning as in the National Health Service Act 1977;]

[F19 “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);]

[F20 “professional register” means the register maintained by the Nursing and Midwifery Council [F21 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;

[F22 “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;];

[F23 “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;]

[F24 “registered midwife” means a person registered in the Midwives' Part of the professional register;]

[F25 “registered nurse” means a person registered in the Nurses' Part of the professional register;]

[F23 “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;]

“registered ophthalmic optician” means a person who is registered in either of the Registers of ophthalmic opticians maintained under section 7(a) of the Opticians Act 1989(12);

[F22 “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;];

[F23 “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;]

[F22 “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;]

[F22 “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;]

[F26 “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

(b)

in relation to a nursing home, the person registered under Part III of the Registered Homes (Northern Ireland) Order 1992 as the person carrying on the nursing home, other than a manager who is to be treated as carrying on the home by virtue of article 17(2) of that order;

[F22 “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;]

[F23 “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;]

“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

(b)

in relation to a nursing home, the manager of the nursing home, unless they are the registered provider for that home;

“relevant register” means—

(a)

in relation to a first level nurse [F27 or registered midwife], the professional register, and

(b)

in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954 or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;]

“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;

[F4 “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;]

F28 ...

F28 ...

[F29 “Strategic Health Authority” means a Strategic Health Authority established under section 8 of the National Health Service Act 1977;]

[F30 “supplementary prescriber” means—

(a)

a first level nurse, F31 ...

(b)

a pharmacist, [F32 or

(c)

a registered midwife,] a pharmacist,

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

[F4 “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).]

(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 [F33 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.

[F34 (7) In articles 12 to [F35 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 supply or adminstration of prescription only medicines includes a reference to an arrangement which covers such 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 (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(a)

F2 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)

F3 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)

F4 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)

F5 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)(i)

F6 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)(c)

F7 Words in art. 1(2) substituted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(b)(i)

F8 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)(ii)

F9 Words in art. 1(2) substituted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 2(2)(b)(ii)

F10 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)(iii)

F11 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)

F12 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)

F13 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)(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)(f)

F15 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)

F16 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

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)(h)

F18 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

F19 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)

F20 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)

F21 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)

F22 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)

F23 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

F24 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)

F25 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)

F26 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)

F27 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)

F28 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)

F29 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

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)(k)

F31 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)

F32 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)

F33 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)

F34 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)

F35 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)

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 [F36 , supplementary prescribers], veterinary surgeons and veterinary practitioners;

[F37 (b) in relation to the descriptions and classes of medicinal products specified in Schedule 3, district nurse/health visitor prescribers;

(c) in relation to the descriptions and classes of medicinal products specified in article 3A(1), extended formulary nurse prescribers.]

Textual Amendments

F36 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

F37 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

[F38 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.

[F39 (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.]]

Textual Amendments

F38 Art. 3 substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 4

F39 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

[F40 Prescribing by extended formulary nurse prescribers

3A.— (1) Subject to paragraph (2), the description and classes of medicinal products in relation to which extended formulary nurse prescribers are appropriate practitioners are those prescription only medicines which consist of, or contain, one or more of the substances specified in column 1 of Schedule 3A, but which do not contain any other substance or combination of substances which is a prescription only medicine not included in Schedule 3A.

(2) [F41 Subject to paragraph (4),] an extended formulary nurse prescriber may—

(a) give a prescription for a medicinal product referred to in paragraph (1); 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 any condition as to the cases or circumstances in which he may do so that is specified by virtue of paragraph (3).

(3) If the entry in column 2 of Schedule 3A relating to a substance specifies one or more requirements as to use, route of administration or pharmaceutical form, it is a condition for the purposes of paragraph (2) that a medicinal product which consists of, or contains, that substance is administered, or is prescribed or directed for administration, in accordance with the specified requirements.

[F42 (4) An extended formulary nurse prescriber may prescribe or administer a medicinal product referred to in paragraph (1), or give directions for administration of such a product, without complying with any condition specified by virtue of paragraph (3) if—

(a) he is a supplementary prescriber; and

(b) he complies with the applicable conditions set out in article 3B(3).]]

Textual Amendments

F40 Art. 3A inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 5

F41 Words in art. 3A(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 5(a)

F42 Art. 3A(4) added (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 5(b)

[F43 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).

(2) Paragraph (1) does not apply if—

(a) the supplementary prescriber is a district nurse/health visitor 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; or

(b) the supplementary prescriber is an extended formulary nurse prescriber and—

(i) 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 article 3A(1), and

(ii) he satisfies any applicable condition specified by virtue of article 3A(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;

(b) at the time the prescription or directions are given or, as the case may be, the product is administered—

(i) a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of the product, or

(ii) the product is, or is to be, administered in the course of a clinical trial [F44 which has been authorised, or is to be treated as having been authorised, by the licensing authority in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2003];

(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

F43 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

F44 Words in art. 3B(3)(b)(ii) 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(b)

Exemptions from conditions in respect of the cases or circumstances in which an extended formulary nurse prescriber or supplementary prescriber may administer a medicinal product

3C.   The conditions specified by virtue of article 3A(3) and in article 3B(3) shall not apply in relation to the administration of a medicinal product by an extended formulary nurse prescriber or 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

F43 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

Duration of special provisions in relation to new medicinal products

F45 4.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F45 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 [F46 ,

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

F46 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

[F47 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

F47 Art. 5A inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 7

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

F48 6.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F48 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

• Chlorpheniramine Injection

• Cobalt Edetate Injection

• Dextrose Injection Strong B.P.C.

• Diphenhydramine Injection

• Glucagon Injection

• Hydrocortisone Injection

• Mepyramine 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.

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 [F49 , a supplementary prescriber] [F50 , a district nurse/health visitor prescriber or an extended formulary nurse prescriber] who by reason of an emergency is unable to furnish a prescription immediately;

(b) that the doctor [F51 , supplementary prescriber] [F52 , district nurse/health visitor prescriber or extended formulary nurse 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 [F53 , supplementary prescriber] [F54 , district nurse/health visitor prescriber or extended formulary nurse 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(13) 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) 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 [F55 , supplementary prescriber] [F56 , district nurse/health visitor prescriber or extended formulary nurse 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 is sold or supplied except that where the prescription only medicine–

(i) is [F57 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.

Textual Amendments

F49 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)

F50 Words in art. 8(2)(a) inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 6(a)(i)

F51 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)

F52 Words in art. 8(2)(b) inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 6(a)(ii)

F53 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)

F54 Words in art. 8(2)(c) inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 6(a)(iii)

F55 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)

F56 Words in art. 8(4)(a)(ii) inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 6(b)

F57 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

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.— [F58 (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 or 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).

[F59 (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

F58 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

F59 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.

[F60 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 an extended formulary nurse prescriber or 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 3A or 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

F60 Art. 12 substituted (31.1.2004) by The Prescription Only Medicines (Human Use) Amendment Order 2004 (S.I. 2004/2), arts. 1(1), 2

[F61 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 [F62 Strategic Health Authority,] Health Authority or Special Health Authority;

(c) an NHS trust [F63 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 [F64 Strategic Health Authority,] Health Authority or Special Health Authority;

(c) an NHS trust [F65 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

F61 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)

F62 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)

F63 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

F64 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)

F65 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

(ii) on behalf of the health authority [F66 or Primary Care Trust]—

(a) in the case of the provision of general medical services or general dental services, with which an arrangement has been made for the provision of those services; or

(b) in the case of the performance of personal medical services or personal dental services, which is a party to the pilot scheme under which those 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—

(i) in relation to England and Wales, the provision of general dental services under Part II of the National Health Service Act 1977, or the performance of personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997;

(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—

[F67 (i) in relation to England and Wales, the provision of primary medical services under Part I of the National Health Service Act 1977;]

[F68 (ii) in relation to Scotland, the provision of primary medical services under Part I of the National Health Service (Scotland) Act 1978; and]

[F69 (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

F61 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)

F66 Words in art. 12B(2)(d)(ii) 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, 8, Sch. 5

F67 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)

F68 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

F69 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 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—

[F70 (a) the medicine is supplied, or as the case may be, is administered by such a person pursuant to an arrangement made with—

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

(ii) an authority or person carrying on the business of an establishment or agency referred to in article 12D(1),

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

(iv) Her Majesty’s Forces,

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

(b) 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

(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 by the person lawfully conducting a retail pharmacy business who 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 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);

[F71 (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;]

[F72 (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 [F73 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 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

F61 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)

F70 Art. 12C(1)(a) substituted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 10(a)

F71 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)

F72 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)

F73 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)

[F74 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 supply or, as the case may be, the administration of a prescription only medicine in the course of the business of—

(a) in England, Wales or Scotland—

(i) an independent hospital,

(ii) an independent clinic, or

(iii) an independent medical agency; or

(b) in Northern Ireland, a nursing home,

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 (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, 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—

(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 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 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.

Textual Amendments

F74 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

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

F74 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

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.

[F75 Exemptions relating to prescriptions given by nurses

13A.— [F76 (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, or

(c) a registered midwife,

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 an extended formulary nurse prescriber [F77 or supplementary prescriber] where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the extended formulary nurse prescriber [F77 or supplementary prescriber] has complied with any condition with which he is required to comply by virtue of [F78 articles 3A(2) and (3) or 3B].]

Textual Amendments

F75 Art. 13A inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 7

F76 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)

F77 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)

F78 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)

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

15.—(1) For the purposes of section 58(2)(a) [F79 , and subject to paragraph (2A),] 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 [F80 , a supplementary prescriber], [F81 a district nurse/health visitor prescriber, an extended formulary nurse prescriber], a veterinary surgeon or a veterinary practitioner,

(iv) where the appropriate practitioner giving it is a doctor, dentist [F82 , a supplementary prescriber] [F83 , a district nurse/health visitor prescriber or an extended formulary nurse 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 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.

[F84 (2A) For the purposes of paragraph (1), where a prescription is issued and dispensed in England and the conditions specified in paragraph (2C) are fulfilled, the prescription may, as an alternative to fulfilling the conditions specified in paragraph (2)(a) and (b), fulfil instead the conditions specified in paragraph (2B).

(2B) The conditions referred to are that the prescription shall be—

(a) created in an electronic form and signed with an 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); or

(b) entered on a document where—

(i) the prescription is created electronically and signed with an electronic signature and both the data and the signature are entered on the document in a non-legible manner;

(ii) the prescription is created in writing on the document, as referred to in paragraph (2)(b), and is signed with an electronic signature which is entered on the document in a non-legible manner; or

(iii) the prescription is created in an electronic form which is entered on the document in a non-legible manner, and is signed as referred to in paragraph (2)(a),

and transferred to the person by whom it is dispensed by physical means.

(2C) The conditions referred to are that—

(a) the prescription is issued by a doctor—

(i) under or by virtue of the National Health Service Act 1997; or

(ii) as part of the performance of personal medical services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1977,

and dispensed by a person lawfully conducting a retail pharmacy business within the meaning of section 69; and

(b) the Secretary of State is satisfied that—

(i) the use of electronic means in order to create, sign and transfer prescriptions (or whichever of those purposes is applicable) is appropriate for the purposes of a pilot scheme on the use of electronic prescribing, in relation to both the doctor and the person lawfully conducting a retail pharmacy business concerned, and in relation to the premises at which the prescription is dispensed; and

(ii) the particular electronic means used by both the doctor and the person lawfully conducting a retail pharmacy business concerned are suitable for the purposes of such a pilot scheme.]

(3) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to a sale or supply of a prescription only medicine which is not in accordance with a prescription given by an appropriate practitioner by reason only that a condition specified in paragraph (2) [F85 or, where applicable, paragraph (2B)] is not satisfied where the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that that condition is satisfied in relation to that sale or supply.

(4) In paragraph (2) “the 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 a 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.

[F86 (5) In paragraphs (2B) and (2C)—

• “doctor” has the same meaning as in section 132(1);

• “electronic communication” has the same meaning as in section 15 of the Electronic Communications Act 2000;

• “electronic signature” has the same meaning as in section 7 of the Electronic Communications Act 2000.]

Textual Amendments

F79 Words in art. 15(1) inserted (E.W.S.) (11.9.2001) by The Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001 (S.I. 2001/2889), arts. 1, 2(a)

F80 Words in art. 15(2)(c)(iii) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 13(a)

F81 Words in art. 15(2)(c)(iii) substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 8(a)

F82 Words in art. 15(2)(c)(iv) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 13(b)

F83 Words in art. 15(2)(c)(iv) substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 8(b)

F84 Art. 15(2A)-(2C) inserted (E.W.S.) (11.9.2001) by The Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001 (S.I. 2001/2889), arts. 1, 2(b)

F85 Words in art. 15(3) inserted (E.W.S.) (11.9.2001) by The Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001 (S.I. 2001/2889), arts. 1, 2(c)

F86 Art. 15(5) added (E.W.S.) (11.9.2001) by The Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001 (S.I. 2001/2889), arts. 1, 2(d)

Revocations

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

(2) In the Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 1989(14) 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
[F87 Acamprosate]
Acarbose
Acebutolol Hydrochloride
[F87 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
[F88 Adapalene]
Adenosine
Adrenaline		(1) By inhaler
		(2) External [F89 (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
[F87 Alendronate Sodium]
Alfacalcidol
Alfuzosin Hydrochloride
Allergen Extracts
Allopurinol
Allyloestrenol
[F90 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
[F88 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
[F91 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
[F87 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
[F88 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
[F92 Aspirin	[F93 (1) 75mg]	[F93 (1) Non-effervescent tablets and capsules]			[F93 (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]
	[F94 [F95 (2)] 500 mg]	[F95 (2)] Non-effervescent tablets and capsules			[F95 (2)] The quantity sold or supplied in one container or package shall not exceed 32
		[F95 (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		F96 . . .	F96 . . .		F96 . . .
		F96 . . .
		F96 . . .
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 [F97 or perennial allergic rhinitis]	280mcg per nostril (MDD)
		For use in adults and children not less than [F98 5 years]
		As a non-aerosol, aqueous form
Azidocillin Potassium
Azithromycin
Azlocillin Sodium
Aztreonam
Bacampicillin Hydrochloride
Bacitracin
Bacitracin Methylene Disalicylate
Bacitracin Zinc
Baclofen
[F91 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 [F99 20,000 mcg] of Beclomethasone Dipropionate
		For the prevention and treatment of allergic rhinitis	200 mcg per nostril (MDD)
			[F100 For a maximum period of 3 months]
		[F101 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
[F91 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
[F88 Bicalutamide]
Biperiden Hydrochloride
Biperiden Lactate
Bismuth Glycollylarsanilate
Bisoprolol Fumarate
Bleomycin
Bleomycin Sulphate
Bretylium Tosylate
[F91 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	[F100 For a maximum period of 3 months]
		200 mcg per nostril (MDD)
		[F101 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
[F102 Cabergoline]
Calcipotriol
[F88 Calcipotriol Hydrate]
Calcitonin
Calcitriol
Calcium Amphomycin
Calcium Benzamidosalicylate
Calcium Bromide
Calcium Bromidolactobionate
Calcium Carbimide
Calcium Folinate
Calcium Metrizoate
Calcium Sulphaloxate
[F103 Candesartan Cilexetil]
Candicidin
Canrenoic Acid
Cantharidin	0.01 per cent	External
Capreomycin Sulphate
Captopril
Carbachol
Carbamazepine
Carbaryl
[F91 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 [F104 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
[F91 Cefdinir]
Cefixime
Cefodizime Sodium
Cefotaxime Sodium
Cefoxitin Sodium
Cefpodoxime Proxetil
[F102 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
[F91 Cerivastatin Sodium]
Ceruletide Diethylamine
Cetirizine Hydrochloride			10mg (MDD)		F105 . . .
Chenodeoxycholic Acid
Chloral Hydrate		External
Chlorambucil
Chloramphenicol
Chloramphenicol Cinnamate
Chloramphenicol Palmitate
Chloramphenicol Sodium Succinate
Chlorhexadol
Chlormadinone Acetate
Chlormerodrin
Chlormethiazole
Chlormethiazole Edisylate
Chlormezanone
Chloroform(15)	(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
[F88 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	[F106 0.05 per cent]	[F106 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)]			[F106 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)
[F87 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
[F90 Diphenhydramine Hydrochloride	All preparations except liquid-filled capsules]
[F107 Diphenoxylate Hydrochloride]	[F107 2.5 mg]	[F107 In combination with Atropine Sulphate for short term use as an adjunctive therapy to appropriate rehydration in acute diarrhoea	[F107 25 mg (MDD)]		[F107 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
[F107 Dolasetron Mesilate]
Domperidone		[F108 For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn]	[F108 10mg of Domperidone (MD)]		[F108 Container or package containing not more than 200mg of Domperidone]
			[F108 40mg of Domperidone (MDD)]
Domperidone Maleate		[F109 For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn,]	[F110 10 mg of Domperidone as Domperidone Maleate (MD)]		[F109 Container or package containing not more than [F111 200mg] of Domperidone as Domperidone Maleate;]
			[F110 40 mg of Domperidone as Domperidone Maleate (MDD)]
[F91 Donepezil Hydrochloride]
Dopamine Hydrochloride
Dopexamine Hydrochloride
[F88 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
[F87 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
[F112 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
[F88 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 [F113 50g] of medicinal product
		[F114 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		[F106 External use (but in the case of vaginal use, only for the treatment of vaginal candidiasis)]
Feprazone
Ferrous Arsenate
[F88 Ferumoxsil]
[F91 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 [F115 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)
		[F116 For use in persons aged 18 years and over]	[F117 For a maximum period of 3 months]
		In the form of a non-pressurised nasal spray
		F118 ...	F118 ...		F118 ...
			F118 . . .
		F118 . . .
		F118 . . .
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	[F119 8.75 mg]	[F120 Throat lozenges]	[F121 43.75 mg (MDD)]		[F122 Container or package containing not more than 140 mg of Flurbiprofen]
Flurbiprofen Sodium
Fluspirilene
Flutamide
Fluticasone Propionate
[F91 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	[F123 (1) 0.5 per cent]	[F123 (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]			[F123 (1) Container or package containing not more than 15g of medicinal product]
	[F124 (2)] 1.0 per cent	[F124 (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 [F125 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			[F124 (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 [F126 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
[F90 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
	[F127 (3) 10.0 per cent]	[F127 (3) External]	[F127 (3) 125 mg (MD) 500 mg (MDD)]		[F127 (3) Container or package containing not more than [F128 50g] of medicinal product]
[F90 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
[F87 Imidapril Hydrochloride]
Imipenem Hydrochloride
Imipramine
Imipramine Hydrochloride
Imipramine Ion Exchange Resin Bound Salt or Complex
[F102 Indapamide]
Indapamide Hemihydrate
Indomethacin
Indomethacin Sodium
Indoprofen
Indoramin Hydrochloride
Inosine Pranobex
[F129 Insulin]
Iodamide
Iodamide Meglumine
Iodamide Sodium
Iohexol
Iomeprol
Iopamidol
Iopentol
Iothalamic Acid
Ioversol
Ioxaglic Acid
Ipratropium Bromide
Iprindole Hydrochloride
Iproniazid Phosphate
[F91 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	[F130 (a)] [F131 External]	[F130 (a)] Maximum frequency of application of once every 3 days		[F130 (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
		[F132 (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
[F102 Lansoprazole]
Latamoxef Disodium
[F102 Lercanidipine Hydrochloride]
Levallorphan Tartrate
Levobunolol Hydrochloride
[F90 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
[F133 Levocarnitine]		[F133 For dietary supplementation]
Levodopa
[F91 Levofloxacin]
Levonorgestrel	[F134 0.75mg]	[F134 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	[F135 equivalent of 0.1 per cent Lodoxamide]	[F136 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)		F137 . . .
[F103 Lornoxicam]
[F103 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		[F138 (a) For the symptomatic relief of irritable bowel syndrome	[F138 (a) 135 mg (MD) 405 mg (MDD)]
		(b) For uses other than the symptomatic relief of irritable bowel syndrome]	[F138 (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
[F102 Meloxicam]
Melphalan
Melphalan Hydrochloride
Menotrophin
Mepenzolate Bromide			25mg (MD)
			75mg (MDD)
Mephenesin
Mephenesin Carbamate
Mepivacaine Hydrochloride		Any use except ophthalmic use
Meptazinol Hydrochloride
Mequitazine
[F91 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	[F139 (1) 2.0 per cent]	[F139 (1) External
	[F139 (2) 5.0 per cent	(2) External use for the treatment of alopecia androgenetica, in men aged 18 to 65 (but not in women);]
[F87 Mirtazapine]
Misoprostol
Mitobronitol
Mitomycin
Mitozantrone Hydrochloride
Mivacurium Chloride
[F112 Mizolastine]
Moclobemide
[F91 Modafinil]
[F88 Moexipril Hydrochloride]
Molgramostim
Molindone Hydrochloride
Mometasone Furoate
Moracizine Hydrochloride
Morazone Hydrochloride
[F87 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
[F91 Naratriptan Hydrochloride]
Natamycin
[F103 Nebivolol Hydrochloride]
Nedocromil Sodium	[F140 2.0 per cent]	[F140 For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis]			[F140 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
[F112 Niceritrol]
Nicotinic Acid		Any use, except for the treatment of hyperlipidaemia	600mg (MDD)
Nicoumalone
Nifedipine
Nifenazone
Nikethamide
[F90 Nilutamide]
Nimodipine
Niridazole
[F103 Nisoldipine]
Nitrendipine
Nitrofurantoin
Nitrofurazone
Nizatidine		For the prevention [F141 and treatment] of the symptoms of food-related heartburn [F141 and meal-induced indigestion]	75mg (MD)
			[F142 150mg (MDD)]
			[F143 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	[F144 3.0 per cent]	[F144 External			[F144 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
[F87 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
[F102 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)
[F92 Paracetamol	(1) [F145 250mg]	(1) Non-effervescent tablets and capsules [F146 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 [F147 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
[F102 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
[F148 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
[F90 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
[F149 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
[F112 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
[F91 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	[F106 3mg]	[F106 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.]	[F106 12mg (MDD)]		[F106 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)
[F103 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
[F103 Quetiapine Fumarate]
[F88 Quinagolide Hydrochloride]
Quinapril
[F149 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
[F87 Ranitidine Bismuth Citrate]
Ranitidine Hydrochloride		For the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity [F150 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
[F91 Reboxetine Mesilate]
Remoxipride Hydrochloride
Reproterol Hydrochloride
Rescinnamine
Reserpine
Rifabutin
Rifampicin
Rifampicin Sodium
Rifamycin
[F87 Rimexolone]
Rimiterol Hydrobromide
Risperidone
Ritodrine Hydrochloride
Rolitetracycline Nitrate
[F107 Ropinirole Hydrochloride]
Sabadilla
Salbutamol
Salbutamol Sulphate
Salcatonin
Salcatonin Acetate
Salmefamol
Salmeterol Xinafoate
Salsalate
Saralasin Acetate
Selegiline Hydrochloride
Semisodium Valproate
[F91 Sertindole]
[F87 Sertraline Hydrochloride]
Serum Gonadotrophin
[F87 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 [F151 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
[F88 Sparfloxacin]
Spectinomycin
Spectinomycin Hydrochloride
Spiramycin
Spiramycin Adipate
Spironolactone
Stannous Fluoride	([F152 1]) 0.62 per cent	([F152 1]) Dentifrice
	[F152 (2) 0.4 per]	[F152 (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
[F90 Strychnine Nitrate]
Styramate
Succinylsulphathiazole
Sucralfate
Sulbactam Sodium
Sulbenicillin
Sulbenicillin Sodium
Sulconazole Nitrate		External (except vaginal)
[F90 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
[F103 Tacalcitol Monohydrate]
Tacrine Hydrochloride
Talampicillin
Talampicillin Hydrochloride
Talampicillin Napsylate
Tamoxifen
Tamoxifen Citrate
[F102 Tamsulosin Hydrochloride]
[F87 Tazarotene]
Tazobactam Sodium
Teicoplanin
[F91 Temocapril Hydrochloride]
Temocillin Sodium
Tenoxicam
Terazosin Hydrochloride
Terbinafine	[F153 1.0 per cent]	[F154 External use for the treatment of tinea pedis, tinea cruris and tinea corporis. In the form of a gel]			[F155 Container or package containing not more than 30 grams of medicinal product]
[F156 Terbinafine Hydrochloride]	[F156 1.0 per cent]	([F157 1]) [F158 Preparations, other than spray solutions, for] [F156 external use for the treatment of tinea pedis and tinea cruris]			([F157 1]) [F156 Container or package containing not more than 15 g of medicinal product.]
		[F159 (2) Spray solutions for external use for the treatment of tinea corporis, tinea cruris and tinea pedis]			[F159 (2) Container containing not more than 30ml of medicinal product]
Terbutaline
Terbutaline Sulphate
Terfenadine			F160 . . .		F160 ...
Terlipressin
Terodiline Hydrochloride
[F91 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
[F102 Ticlopidine Hydrochloride]
Tigloidine Hydrobromide
[F102 Tiludronate Disodium]
Timolol Maleate
Tinidazole
Tinzaparin
Tioconazole	(1) 2.0 per cent	(1) External (except vaginal)
		(2) Vaginal for treatment of vaginal candidiasis
[F88 Tizanidine Hydrochloride]
Tobramycin
Tobramycin Sulphate
Tocainide Hydrochloride
Tofenacin Hydrochloride
Tolazamide
Tolazoline Hydrochloride		External
Tolbutamide
Tolbutamide Sodium
Tolfenamic Acid
Tolmetin Sodium
[F87 Topiramate]
[F112 Torasemide]
[F102 Toremifene]
Tramadol Hydrochloride
Trandolapril
Tranexamic Acid
Tranylcypromine Sulphate
Trazodone Hydrochloride
Treosulfan
Tretinoin
Triamcinolone
Triamcinolone Acetonide	[F161 (1)] 0.1 per cent	[F161 (1)] For the treatment of common mouth ulcers			[F161 (1)] Container or package containing not more than 5g of medicinal product
		[F162 (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]	[F162 (2) 110mcg per nostril (MD)		[F162 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)
[F88 Valaciclovir Hydrochloride]
Valproic Acid
[F91 Valsartan]
Vancomycin Hydrochloride
Vasopressin
Vasopressin Tannate
Vecuronium Bromide
[F88 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
[F88 Zalcitabine]
Zidovudine
Zimeldine Hydrochloride
Zolpidem Tartrate
Zomepirac Sodium
Zopiclone
Zuclopenthixol Acetate
Zuclopenthixol Decanoate
Zuclopenthixol Hydrochloride]

Textual Amendments

F87 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)

F88 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)

F89 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)

F90 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.

F91 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)

F92 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

F93 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)

F94 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)

F95 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)

F96 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)

F97 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)

F98 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)

F99 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)

F100 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)

F101 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)

F102 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)

F103 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)

F104 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)

F105 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)

F106 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)

F107 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)

F108 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)

F109 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)

F110 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)

F111 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)

F112 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)

F113 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)

F114 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)

F115 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)

F116 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)

F117 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)

F118 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)

F119 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)

F120 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)

F121 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)

F122 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)

F123 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)

F124 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)

F125 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)

F126 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)

F127 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)

F128 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)

F129 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)

F130 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)

F131 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)

F132 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)

F133 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)

F134 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

F135 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)

F136 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)

F137 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)

F138 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)

F139 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)

F140 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)

F141 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)

F142 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)

F143 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)

F144 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)

F145 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)

F146 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)

F147 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)

F148 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)

F149 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)

F150 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)

F151 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)

F152 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)

F153 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)

F154 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)

F155 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)

F156 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)

F157 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)

F158 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)

F159 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)

F160 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)

F161 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)

F162 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)

Articles 6(1) and 10

SCHEDULE 2

Column 1	Circumstances excluding medicinal products from the class of prescription only medicines
	Column 2	Column 3	Column 4
Substance	Maximum strength	Pharmaceutical Form	Maximum Dose
Codeine and its salts	Equivalent of 1.5 per cent of codeine monohydrate		Equivalent of 20 mg of codeine monohydrate
Dihydrocodeine and its salts	Equivalent of 1.5 per cent of dihydrocodeine		Equivalent of 10 mg of dihydrocodeine
Ethylmorphine andits salts	Equivalent of 0.2 per cent of ethylmorphine		Equivalent of 7.5 mg of ethylmorphine
Morphine and its salts	(1) Equivalent of 0.02 per cent anhydrous morphine	(1) Liquid	(1) Equivalent of 3 mg of anhydrous morphine
	(2) Equivalent of 0.04 per cent of anhydrous morphine; equivalent of 300 mcg of anhydrous morphine	(2) Solid	(2) Equivalent of 3 mg of anhydrous morphine
Medicinal Opium	(1) Equivalent of 0.02 per cent of anhydrous morphine	(1) Liquid	(1) Equivalent of 3 mg of anhydrous morphine
	(2) Equivalent of 0.04 per cent of anhydrous morphine	(2) Solid	(2) Equivalent of 3 mg of anhydrous morphine
Pholcodine and its salts	Equivalent of 1.5 per cent of pholcodine monohydrate		Equivalent of 20 mg of pholcodine monohydrate

Article 2(b)

SCHEDULE 3 DESCRIPTIONS AND CLASSES OF PRESCRIPTION ONLY MEDICINES IN RELATION TO WHICH APPROPRIATE NURSE PRACTITIONERS ARE APPROPRIATE PRACTITIONERS

• [F163 Co-danthramer Capsules NPF]

• [F163 Co-danthramer Capsules, Strong NPF]

• Co-danthramer-Oral Suspension NPF

• Co-danthramer-Oral Suspension Strong NPF

• Co-danthrusate Capsules

• [F163 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

• [F164 Water for Injections]

Textual Amendments

F163 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

F164 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

[F165 SCHEDULE 3A SUBSTANCES WHICH MAY BE PRESCRIBED, ADMINISTERED OR DIRECTED FOR ADMINISTRATION BY EXTENDED FORMULARY NURSE PRESCRIBERS AND CONDITIONS FOR SUCH PRESCRIPTION OR ADMINISTRATION

Textual Amendments

F165 Sch. 3A inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 9

Column 1	Column 2
Substance	Requirements as to use, route of administration, or pharmaceutical form
Aciclovir	External use
Acrivastine	Oral
Adapalene	External use
Alclometasone dipropionate	External use
Alimemazine tartrate (trimeprazine tartrate)	Oral
[F166 Amitriptyline hydrochloride	Oral]
Amorolfine hydrochloride	External use
Amoxycillin trihydrate	Oral
Aspirin	Oral
Azelaic acid	External use
Azelastine hydrochloride	Ophthalmic use or nasal
[F166 Azithromycin dihydrate	Oral]
Baclofen	Oral administration in palliative care
Beclometasone dipropionate	External use or nasal
Betamethasone dipropionate	External use
Betamethasone sodium phosphate	Aural or nasal
Betamethasone valerate	External use
Budesonide	Nasal
[F166 Carbamazepine	Oral or rectal]
Carbaryl	External use
Carbenoxolone sodium	Mouthwash
Cetirizine hydrochloride	Oral
Chloramphenicol	Ophthalmic use
Cimetidine	Oral
Cinchocaine hydrochloride	External use
[F166 Clavulanic acid [F167 (as potassium clavulanate)]	Oral]
Clindamycin phosphate	External use
Clobetasone butyrate	External use
Clotrimazole	External use
[F168 Codeine Phosphate	Oral]
[F166 Conjugated oestrogens (equine)	External use]
[F168 Co-Phenotrope	Oral]
Cyclizine	Parenteral administration in palliative care
Dantrolene sodium	Oral administration in palliative care
Dantron	Oral
Desogestrel	Oral
Desoximetasone (Desoxymethasone)	External use
Dexamethasone	Aural
Dexamethasone isonicotinate	Nasal
[F168 Diazepam	Oral, parenteral or rectal administration in palliative care]
Diclofenac diethylammonium	External use
[F166 Diclofenac potassium	Oral]
[F166 Diclofenac sodium	Oral or rectal]
[F168 Dihydrocodeine Tartrate	Oral]
Domperidone	Oral or rectal administration in palliative care
Domperidone maleate	Oral administration in palliative care
Doxycycline [F169 hyclate]	Oral
[F170 Doxycycline monohydrate	Oral]
Econazole nitrate	External use
[F170 Emedastine	Ophthalmic use]
Erythromycin	External use [F171 or oral]
[F166 Erythromycin ethyl succinate	Oral]
[F166 Erythromycin stearate	Oral]
[F166 Estradiol	External use]
[F166 Estriol	External use]
Ethinylestradiol	Oral
[F166 Etonogestrel	Implant]
Etynodiol diacetate (ethynodiol diacetate)	Oral
Famotidine	Oral
Felbinac	External use
Fenticonazole nitrate	External use
Fexofenadine hydrochloride	Oral
[F170 Flucloxacillin magnesium	Oral]
Flucloxacillin sodium	Oral
Fluconazole	Oral
Fludroxycortide (Flurandrenolone)	External use
[F166 Flumazenil	Parenteral]
Flumetasone pivalate	Aural
Flunisolide	Nasal
Fluocinolone acetonide	External use
Fluocinonide	External use
Fluocortolone hexanoate	External use
Fluocortolone pivalate	External use
Flurbiprofen	Lozenges
Fluticasone propionate	External use or nasal
Fusidic acid	[F172 External Use]
[F166 Gabapentin	Oral]
Gentamicin sulphate	Aural
Gestodene	Oral
[F166 Glucagon hydrochloride	Parenteral]
[F166 Glucose	Parenteral]
Hydrocortisone	External use
Hydrocortisone acetate	External use [F173 or aural]
Hydrocortisone butyrate	External use
Hydrocortisone sodium succinate	Lozenges
[F174 Hyoscine	Transdermal administration in palliative care]
Hyoscine butylbromide	Parenteral F175 ... administration in palliative care
Hyoscine hydrobromide	[F176 Oral or parenteral administration in palliative care]
Ibuprofen	External use or oral
Ibuprofen lysine	Oral
[F166 Imipramine hydrochloride	Oral]
Ipratropium bromide	Nasal
Isotretinoin	External use
Ketoconazole	External use
Ketoprofen	External use
Levocabastine hydrochloride	Ophthalmic use or nasal
Levomepromazine (methotrimeprazine) maleate	Oral administration in palliative care
Levomepromazine (methotrimeprazine) hydrochloride	Parenteral administration in palliative care
Levonorgestrel	Oral
[F166 Lignocaine hydrochloride	External use or parenteral]
Lithium succinate	External use
Lodoxamide trometamol	Ophthalmic use
Loperamide hydrochloride	Oral
Loratadine	Oral
[F168 Lorazepam	Oral or parenteral administration in palliative care]
[F166 Lymecycline	Oral]
Mebendazole	Oral
Medroxyprogesterone acetate	Parenteral
Mestranol	Oral
Metoclopramide hydrochloride	Oral or parenteral administration in palliative care
Metronidazole	[F177 External use, oral or rectal]
Metronidazole benzoate	Oral
Miconazole	Dental lacquer
Miconazole nitrate	External use
[F168 Midazolam	Parenteral administration in palliative care]
Minocycline	Oral
[F170 Mizolastine	Oral]
[F170 Minocycline hydrochloride	Oral
Mometasone furoate	External use or nasal
Nedocromil sodium	Ophthalmic use
Nefopam hydrochloride	Oral
Neomycin sulphate	Aural
Neomycin undecenoate	Aural
Nitrofurantoin	Oral
Nizatidine	Oral
Norethisterone 9	Oral
Norethisterone acetate	Oral
Norethisterone enanthate	Parenteral
Norgestimate	Oral
Norgestrel	Oral
[F166 Nortriptyline hydrochloride	Oral]
Nystatin	External use
Oxytetracycline dihydrate	Oral
Paracetamol	Oral
Penciclovir	External use
Piroxicam	External use
[F166 Prednisolone	Oral]
Prednisolone hexanoate	External use
Prednisolone sodium phosphate	Aural [F178 or oral]
Ranitidine hydrochloride	Oral
[F166 Salbutamol sulphate	Inhalation]
Silver sulphadiazine	External use
Sodium cromoglycate	Ophthalmic use
[F166 Sodium fusidate	External use]
Streptodornase	External use
Streptokinase	External use
Sulconazole nitrate	External use
Terbinafine hydrochloride	External use
[F166 Terbutaline sulphate	Inhalation]
Tetracycline hydrochloride	External use or oral
Tretinoin	External use
Triamcinolone acetonide	External use, aural, nasal or oral paste
Trimethoprim	Oral
Tuberculin PPD	Parenteral
Vaccine, Adsorbed Diphtheria	Parenteral
Vaccine, Adsorbed Diphtheria And Tetanus	Parenteral
Vaccine, Adsorbed Diphtheria And Tetanus For Adults And Adolescents	Parenteral
Vaccine, Adsorbed Diphtheria For Adults And Adolescents	Parenteral
Vaccine, Adsorbed Diphtheria, Tetanus And Pertussis	Parenteral
Vaccine, Adsorbed Diphtheria, Tetanus And Pertussis (Acellular Component)	Parenteral
Vaccine, BCG	Parenteral
Vaccine, BCG Percutaneous	Parenteral
Vaccine, Haemophilus Influenzae Type B (Hib)	Parenteral
Vaccine, Haemophilus Influenzae Type B (Hib) with Diphtheria, Tetanus And Pertussis	Parenteral
Vaccine, Haemophilus Influenzae Type B, Diphtheria, Tetanus And Acellular Pertussis	Parenteral
Vaccine, Hepatitis A	Parenteral
Vaccine, Hepatitis A With Typhoid	Parenteral
Vaccine, Hepatitis A, Inactivated, With Recombinant (DNA) Hepatitis B	Parenteral
Vaccine, Hepatitis B	Parenteral
Vaccine, Influenza	Parenteral
Vaccine, Live Measles, Mumps And Rubella (MMR)	Parenteral
Vaccine, Meningococcal Group C Conjugate	Parenteral
Vaccine, Meningococcal Polysaccharide A and C	Parenteral
Vaccine, Pneumococcal	Parenteral
F179 . . .	F179 . . .
Vaccine, Poliomyelitis, Live (Oral)	Oral
Vaccine, Rubella, Live	Parenteral
Vaccine, Tetanus, Adsorbed	Parenteral
Vaccine, Typhoid, Live Attenuated (Oral)	Oral
Vaccine, Typhoid, Polysaccharide	Parenteral
[F170 Water for Injections	Parenteral]]

Textual Amendments

F166 Sch. 3A entries inserted (31.1.2004) by The Prescription Only Medicines (Human Use) Amendment Order 2004 (S.I. 2004/2), arts. 1(1), 3(g)

F167 Words in Sch. 3A added (18.5.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2004 (S.I. 2004/1189), arts. 1(1), 3(a)

F168 Words in Sch. 3A inserted (10.12.2003) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2003 (S.I. 2003/2915), arts. 1(1), 3

F169 Words in Sch. 3A inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 15(a)

F170 Words in Sch. 3A inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 15(c)

F171 Words in Sch. 3A inserted (31.1.2004) by The Prescription Only Medicines (Human Use) Amendment Order 2004 (S.I. 2004/2), arts. 1(1), 3(a)

F172 Words in Sch. 3A substituted (31.1.2004) by The Prescription Only Medicines (Human Use) Amendment Order 2004 (S.I. 2004/2), arts. 1(1), 3(b)

F173 Words in Sch. 3A added (18.5.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2004 (S.I. 2004/1189), arts. 1(1), 3(b)

F174 Words in Sch. 3A inserted (18.5.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2004 (S.I. 2004/1189), arts. 1(1), 3(d)

F175 Words in Sch. 3A omitted (18.5.2004) by virtue of The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2004 (S.I. 2004/1189), arts. 1(1), 3(c)

F176 Words in Sch. 3A substituted (31.1.2004) by The Prescription Only Medicines (Human Use) Amendment Order 2004 (S.I. 2004/2), arts. 1(1), 3(d)

F177 Words in Sch. 3A substituted (31.1.2004) by The Prescription Only Medicines (Human Use) Amendment Order 2004 (S.I. 2004/2), arts. 1(1), 3(e)

F178 Words in Sch. 3A substituted (31.1.2004) by The Prescription Only Medicines (Human Use) Amendment Order 2004 (S.I. 2004/2), arts. 1(1), 3(f)

F179 Words in Sch. 3A omitted (4.4.2003) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 15(b)

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

[F180 SCHEDULE 3B PARTICULARS FOR CLINICAL MANAGEMENT PLANS

Textual Amendments

F180 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 MEDI CINE 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(16) or article 36 of the Food (Northern Ireland) Order 1989(17), (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(18), the National Health Service (Scotland) Act 1978(19) and the Health and Personal Social Services (Northern Ireland) Order 1972(20), 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 [F181 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: Atropine sulphate Bethanecol chloride Carbachol Cyclopentolate hydrochloride Homatropine hydrobromide Naphazoline hydrochloride Naphazoline nitrate Physostigmine salicylate Physostigmine sulphate Pilocarpine hydrochloride Pilocarpine nitrate Tropicamide.	5. The sale or supply shall be subject to the presentation of an order signed by a registered ophthalmic optician.
6. Registered ophthalmic opticians.	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.
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(21) 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(22).	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.
[F182 10.  F183 ... registered chiropodists who hold a certificate of competence in the use of the medicines specified in Column 2 issued by or with the approval of the Chiropodists Board [F184 or the Health Professions Council].	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; and (d) Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight.	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

F181 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)

F182 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.

F183 Word in Sch. 5 Pt. 1 para. 10 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(3)(a)(i)

F184 Words in Sch. 5 Pt. 1 para. 10 inserted (9.7.2003) by The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(3)(a)(ii)

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.
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.

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
1. F185 ... registered chiropodists who hold a certificate of competence in the use of analgesics issued by or with the approval of the Chiropodists Board [F186 or the Health Professions Council].	1. Prescription only medicines for parenteral administration that contain,as the sole active ingredient, not more than one of the following substances– [F187 Bupivacaine hydrochloride Bupivacaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of bupivacaine 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 [F188 Mepivacaine hydrochloride] Prilocaine 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– [F189 Diamorphine] Ergometrine maleate Lignocaine Lignocaine hydrochloride [F189 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 [F190 or persons who are [F191 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) [F192 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 Anhydrous Glucose [F193 Benzylpenicillin] [F194 Bretylium Tosylate] Compound Sodium Lactate Intravenous Infusion (Hartmann’s Solution) Ergometrine Maleate [F193 Frusemide] Glucose Heparin Sodium Lignocaine Hydrochloride [F193 Metoclopramide] [F193 Morphine Sulphate] Nalbuphine Hydrochloride Naloxone Hydrochloride Polygeline [F195 Reteplase ] Sodium Bicarbonate Sodium Chloride [F193 Streptokinase] [F195 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

F185 Word in Sch. 5 Pt. 3 para. 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(3)(b)(i)(aa)

F186 Words in Sch. 5 Pt. 3 para. 1 inserted (9.7.2003) by The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(3)(b)(i)(bb)

F187 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)

F188 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)

F189 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

F190 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)

F191 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)

F192 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)

F193 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)

F194 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

F195 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

[F196 SCHEDULE 7

Textual Amendments

F196 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 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.

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
[F197 Strategic Health Authority]	[F197 The Strategic Health Authority]
Health Authority	The Health Authority
Special Health Authority	The Special Health Authority
NHS trust [F198 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, [F199 , 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 [F200 or NHS foundation trust] or Primary Care Trust with which the arrangement has been made]

Textual Amendments

F197 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)

F198 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

F199 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

F200 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

[F201 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

F201 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 [F202 BY WHOM PRESCRIPTION ONLY MEDICINES MAY BE SUPPLIED OR ADMINISTERED]

Textual Amendments

F202 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)

• [F203 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.

• F204 ...

• Registered midwives.

• Registered nurses.

• Registered ophthalmic opticians.

• [F205 Registered] chiropodists.

• [F206 Registered orthoptists.

• Registered physiotherapists.

• Registered radiographers.]

• [F207 Registered dietitians.]

• [F207 Registered occupational therapists.]

• [F207 Registered orthotists and prosthetists.]

• [F207 Registered speech and language therapists.]]

Textual Amendments

F203 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)

F204 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)

F205 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)

F206 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)

F207 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)

1989 c. 44.

(13)

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

(14)

S.I. 1989/1852.

(15)

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

(16)

1990 c. 16.

(17)

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

(18)

1977 c. 49.

(19)

1978 c. 29.

(20)

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

(21)

1972 c. 66.

(22)

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