The Prescription Only Medicines (Human Use) Order 1997

Citation, commencement and interpretation

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

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

“the Act” means the Medicines Act 1968;

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

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

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

(a)

the patient to whom the plan relates,

(b)

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

(c)

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

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

F4 ...

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

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

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

(a)

who is a registered nurse or a registered midwife, and

(b)

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

“controlled drug” has the meaning assigned to it by section 2 of the Misuse of Drugs Act 1971(1);

“cyanogenetic substances” means preparations which–

(a)

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

(b)

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

[F8 “dental hygienist” means a person whose name is registered under the title of dental hygienist in the dental care professionals register;

“dental therapist” means a person whose name is registered under the title of dental therapist in the dental care professionals register;

“dental care professionals register” means the dental care professionals register established under section 36B of the Dentists Act 1984;]

F9 ...

“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;

F10 ...

F11 ...

“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;

F12 ...

[F5 “Health Authority”—

(a)

F13 ...

(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;]

[F14 “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 [F15 , supplementary prescriber] , [F16 a community practitioner nurse prescriber, a nurse independent prescriber or a pharmacist independent prescriber] under or by virtue of–

(a)

in England and Wales, the National Health Service Act 1977(2),

(b)

in Scotland, the National Health Service (Scotland) Act 1978(3), and

(c)

in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 1972(4);

[F17 “health record” has the meaning given by section 68(2) of the Data Protection Act 1998(4);]

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

[F18 “independent clinic”—

(a)

in relation to England and Wales, has the meaning given by section 2(4) of the Care Standards Act 2000(6), and

(b)

in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act [F19 2001, and];]

(c)

[F20 in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;]

[F18 “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 [F21 2001, and]]

(c)

[F22 in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;]

[F18 “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 [F23 2001, and]]

(c)

[F24 in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;]

“inhaler” does not include an aerosol;

[F25 “IRME practitioner” means, in relation to a medical exposure, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2000(2);]

[F26 “Local Health Board” has the same meaning as in the National Health Service Act 1977;]

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

“master” has the same meaning as in section 313(1) of the Merchant Shipping Act 1995(5);

“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;

[F27 “medical exposure” has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000;]

“medicinal product” includes any article or substance in respect of which section 58 of the Act has effect by virtue of an order made under section 104 of the ActF28 ...

“the Misuse of Drugs Regulations” means, in relation to England, Wales and Scotland, the Misuse of Drugs Regulations 1985(6) and in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1986(7);

[F5 “NHS trust”—

(a)

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

(b)

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

(c)

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

[F29 “nurse independent prescriber” means a person—

(a)

who is a registered nurse or a registered midwife, and

(b)

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

[F30 “NHS foundation trust” has the same meaning as in section 1(1) of the Health and Social Care (Community Health and Standards) Act 2003;]

[F31 “nursing home” has the meaning given by article 16 [F32 article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003];]

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

“offshore installation” means an offshore installation within the meaning of the Mineral Workings (Offshore Installations) Act 1971(8) 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(9);

[F33 “operator”—

(a)

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

(b)

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

[F34 “optometrist independent prescriber” means a person—

(a)

who is a registered optometrist, and

(b)

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

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

[F5 “Patient Group Direction” means—

(a)

in connection with the [F35 sale or] supply of a prescription only medicine as referred to in article 12A(2), [F36 12B, 12C, 12D or 12E], a written direction relating to the [F37 sale or supply, and administration,] of a description or class of prescription only medicine; or

(b)

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

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

  (i)

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

  (ii)

  relates to [F38 sale or] supply and administration, or to administration, to persons generally (subject to any exclusions which may be set out in the Direction);]

[F39 “pharmacist independent prescriber” means a person—

(a)

who is a pharmacist, and

(b)

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

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

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

[F40 “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);]

[F41 “professional register” means the register maintained by the Nursing and Midwifery Council [F42 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;

[F43 “radioactive medicinal product” means a medicinal product which is, which contains or which generates a radioactive substance and which is, contains or generates that substance in order, when administered, to utilize the radiation emitted therefrom;]

[F44 “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;];

[F45 “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;]

[F46 “registered midwife” means a person registered in the Midwives' Part of the professional register;]

[F47 “registered nurse” means a person registered in the Nurses' Part [F48 or Specialist Community Public Health Nurses' Part] of the professional register;]

[F45 “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;]

[F49 “registered optometrist” means a person whose name is registered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989, or in the register of visiting optometrists from relevant European States maintained under section 8B(1)(a) of that Act;]

[F44 “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;];

[F45 “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;]

[F44 “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;]

[F44 “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;]

[F50 “registered provider” means—

(a)

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

(i)

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

(ii)

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

(iiii)

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

(b)

[F52 in relation to a nursing home, the person registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the person carrying on the establishment;]]

[F44 “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;]

[F45 “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;]

[F50 “relevant manager” means—

(a)

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

(i)

in relation to England and Wales—

(aa)

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

(bb)

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

(ii)

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

(iii)

[F53 in relation to Northern Ireland—

(aa)

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

(bb)

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

(b)

[F54 in relation to a nursing home—

(i)

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

(ii)

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

[F50 “relevant register” means—

(a)

in relation to a [F55 registered] nurse [F56 or registered midwife], the professional register, F57 ...

(b)

in relation to a pharmacist, [F58 Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007] or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976; F59 ...

(c)

[F60 in relation to a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

(i)

chiropodists and podiatrists;

(ii)

physiotherapists; or

(iii)

radiographers diagnostic or therapeutic

that register [F61 ; and]

(d)

[F62 in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989;]]

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

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

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

[F5 “Special Health Authority”—

(a)

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

(b)

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

(c)

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

F63 ...

F63 ...

[F64 “Strategic Health Authority” means a Strategic Health Authority established under section 8 of the National Health Service Act 1977;]

[F65 “supplementary prescriber” means—

(a)

a [F66 registered] nurse, F67 ...

(b)

a pharmacist, F68 [F69 ...

(c)

a registered midwife,] F70 ...

(d)

[F71 a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

(i)

chiropodists and podiatrists;

(ii)

physiotherapists; or

(iii)

radiographers diagnostic or therapeutic [F72 or]]

(e)

[F73 a registered optometrist, ]

against whose name is recorded in the relevant register an annotation [F74 or entry] signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber [F75 or, in the case of a nurse or midwife, as a nurse independent/supplementary prescriber]; ]

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

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

[F5 “United Kingdom marketing authorization” means a marketing authorization granted by the licensing authority under the Medicines For Human Use (Marketing Authorisations Etc.) Regulations 1994 (including a product licence having effect as such an authorization by virtue of Schedule 6 to those Regulations [F76 or an authorization granted by the licensing authority in accordance with Article 126a of Directive 2001/83/EC]).]

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

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

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

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

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

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

(5) In [F77 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.

[F78 (7) In articles 12 to [F79 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 [F80 sale,] supply or adminstration of prescription only medicines includes a reference to an arrangement which covers such [F81 sale,] supply or administration and other matters.

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

Textual Amendments

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

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

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

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

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

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

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

F8 Words in art. 1(2) inserted (1.6.2010) by The Medicines for Human Use (Miscellaneous Amendments) Order 2010 (S.I. 2010/1136), arts. 1(1), 3(2)

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

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

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

F12 Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(e)

F13 Words in art. 1(2) repealed (8.5.2009) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2009 (S.I. 2009/1165), arts. 1, 2

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)(d)

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)(e)

F16 Words in art. 1(2) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(f)

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)(f)

F18 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)

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

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

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

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

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

F24 Words in art. 1(2) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(c)(ii)

F25 Words in art. 1(2) inserted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 2(a)

F26 Words in art. 1(2) inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 2

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

F28 Words in art. 1(2) omitted (17.11.2006) by virtue of The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 2(c)

F29 Words in art. 1(2) inserted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(g)

F30 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

F31 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)

F32 Words in art. 1(2) substituted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(d)

F33 Words in art. 1(2) substituted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 2(d)

F34 Words in art. 1(2) inserted (4.6.2008) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008 (S.I. 2008/1161), arts. 1(1), 2

F35 Words in art. 1(2) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(e)(i)(aa)

F36 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

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

F38 Words in art. 1(2) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(e)(ii)

F39 Words in art. 1(2) inserted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(h)

F40 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)

F41 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)

F42 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)

F43 Words in art. 1(2) inserted (17.11.2006) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 (S.I. 2006/2807), arts. 1(1), 2(e)

F44 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)

F45 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

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

F47 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)

F48 Words in art. 1(2) inserted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(i)

F49 Words in art. 1(2) substituted (3.12.2007) by The European Qualifications (Health and Social Care Professions) Regulations 2007 (S.I. 2007/3101), regs. 1(2), 197

F50 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)

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

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

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

F54 Words in art. 1(2) substituted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(2)(g)(ii)

F55 Word in art. 1(2) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(j)

F56 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)

F57 Word in art. 1(2) omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 3(a)(i)

F58 Words in art. 1(2) substituted (coming into force in accordance with art. 1(2)(3) of the amending S.I.) by The Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), Sch. 1 para. 20

F59 Word in art. 1(b) omitted (30.6.2005) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(b)(i)

F60 Words in art. 1(2) inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 3(a)(iii)

F61 Word in art. 1(c) inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(b)(ii)

F62 Words inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(b)(iii)

F63 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)

F64 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

F65 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)

F66 Word in art. 1(2) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(k)(i)

F67 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)

F68 Word in art. 1(2) omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 3(b)(i)

F69 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)

F70 Word in art. 1(2)(c) omitted (30.6.2005) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(c)(i)

F71 Words in art. 1(2) inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 3(b)(iii)

F72 Word in art. 1(2)(d) inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(c)(ii)

F73 Art. 1(2)(e) inserted (30.6.2005) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 (S.I. 2005/1507), arts. 1(1), 3(c)(iii)

F74 Words in art. 1(2) inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 3(c)

F75 Words in art. 1(2) inserted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(k)(ii)

F76 Words in art. 1(2) inserted (20.11.2005) by The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), reg. 1(b), Sch. para. 5(b)

F77 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)

F78 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)

F79 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)

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

F81 Word in art. 1(8) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 2(3)(b)

(1)

1971 c. 38.

(2)

1977 c. 49.

(3)

1978 c. 29.

(4)

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

(5)

1995 c. 21.

(6)

S.I. 1985/2066.

(7)

SR 1986 No. 52.

(8)

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

(9)

1964 c. 29.