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Statutory Instruments
MEDICINES
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:
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—
the patient to whom the plan relates,
the doctor or dentist who is a party to the plan, and
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–
are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17, or
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–
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
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—
“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”—
in relation to England and Wales, has the same meaning as in the National Health Service Act 1977;
in relation to Scotland, means a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and
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–
[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”—
in relation to England and Wales, has the meaning given by section 2(4) of the Care Standards Act 2000(8), and
in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001;]
[F15“independent hospital”—
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
in relation to Scotland, means—
an independent hospital, or
a private psychiatric hospital,
as defined by section 77(1) of the Regulation of Care (Scotland) Act 2001;]
[F15“independent medical agency”—
in relation to England and Wales, has the meaning given by section 2(5) of the Care Standards Act 2000, and
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;
[F16“Local Health Board” has the same meaning as in the National Health Service Act 1977;]
[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–
the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;
the maximum percentage of a substance contained in a medicinal product calculated in any of the following ways–
weight in weight,
weight in volume,
volume in weight, or
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 medicinal product which is a veterinary drug as defined in section 132(1) of the Act or
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”—
in relation to England and Wales, has the same meaning as in the National Health Service and Community Care Act 1990;
in relation to Scotland, has the same meaning as in the National Health Service (Scotland) Act 1978; and
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;]
[F17“NHS foundation trust” has the same meaning as in section 1(1) of the Health and Social Care (Community Health and Standards) Act 2003;]
[F18“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–
tidal waters and parts of the sea in or adjacent to the United Kingdom up to the seaward limits of territorial waters;
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—
in connection with the supply of a prescription only medicine as referred to in article 12A(2), [F1912B, 12C, 12D or 12E], a written direction relating to the supply and administration of a description or class of prescription only medicine; or
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)—
is signed by a doctor or dentist, and by a pharmacist; and
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;]
[F20“prison service” means—
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),
in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 1989), and
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);]
[F21“professional register” means the register maintained by the Nursing and Midwifery Council [F22under article 5 of] the Nursing and Midwifery Order 2001;]
“prolonged release” in relation to a medicinal product means a formulation of that product which–
is used to reduce the rate at which the active ingredient in that product is released after administration, and
is sold or supplied as a prolonged, controlled or sustained release medicinal product;
[F23“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;];
[F24“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;]
[F25“registered midwife” means a person registered in the Midwives' Part of the professional register;]
[F26“registered nurse” means a person registered in the Nurses' Part of the professional register;]
[F24“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);
[F23“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;];
[F24“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;]
[F23“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;]
[F23“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;]
[F27“registered provider” means—
in relation to an independent hospital, an independent clinic or an independent medical agency—
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,
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
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;
[F23“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;]
[F24“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;]
[F27“relevant manager” means—
in relation to an independent hospital, an independent clinic or an independent medical agency—
in relation to England and Wales—
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
if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person,
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
in relation to a nursing home, the manager of the nursing home, unless they are the registered provider for that home;]
[F27“relevant register” means—
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; [F30and]
[F31in 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—
chiropodists and podiatrists;
physiotherapists; or
radiographers diagnostic or therapeutic
that register;]]
“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”—
in relation to England and Wales, has the same meaning as in the National Health Service Act 1977;
in relation to Scotland, means a Special Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and
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;]
F32...
F32...
[F33“Strategic Health Authority” means a Strategic Health Authority established under section 8 of the National Health Service Act 1977;]
[F34“supplementary prescriber” means—
a first level nurse, F35...
a registered midwife,] [F38or]
[F39a 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—
chiropodists and podiatrists;
physiotherapists; or
radiographers diagnostic or therapeutic]
against whose name is recorded in the relevant register an annotation [F40or entry] 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 [F41Schedules 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.
[F42(7) In articles 12 to [F4312E], 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
F1Words 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)
F2Words 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)
F3Words 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)
F4Words 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)
F5Words 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)
F6Words 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)
F7Words 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)
F8Words 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)
F9Words 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)
F10Words 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)
F11Words 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)
F12Words 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)
F13Words 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)
F14Words 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)
F15Words 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)
F16Words 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
F17Words 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
F18Words 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)
F19Words 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
F20Words 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)
F21Words 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)
F22Words 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)
F23Words 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)
F24Words 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
F25Words 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)
F26Words 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)
F27Words 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)
F28Words 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)
F29Word 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)
F30Word 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)(ii)
F31Words 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)
F32Words 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)
F33Words 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
F34Words 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)
F35Word 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)
F36Word 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)
F37Words 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)
F38Word 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)(ii)
F39Words 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)
F40Words 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)
F41Words 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)
F42Words 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)
F43Word 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)
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 [F44, supplementary prescribers], veterinary surgeons and veterinary practitioners;
[F45(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
F44Words 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
F45Art. 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
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.
[F47(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
F46Art. 3 substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 4
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) [F49Subject 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.
[F50(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
F48Art. 3A inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 5
F49Words 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)
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;
F52(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c)the supplementary prescriber has access to the health records of the patient to whom the plan relates which are used by any doctor or dentist who is a party to the plan.
Textual Amendments
F51Arts. 3B, 3C inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 6
F52Art. 3B(3)(b) omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 4
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
F51Arts. 3B, 3C inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 6
F534. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F53Art. 4 revoked (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 11
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 [F54,
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
F54Words 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
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
F55Art. 5A inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 7
F566. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F56Art. 6 revoked (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 11
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
[F57Atropine sulphate and obidoxime chloride injection]
[F57Atropine sulphate and pralidoxime chloride injection]
[F57Atropine sulphate, pralidoxime mesilate and avizafone injection]
Chlorpheniramine Injection
Cobalt Edetate Injection
Dextrose Injection Strong B.P.C.
Diphenhydramine Injection
Glucagon Injection
Hydrocortisone Injection
Mepyramine Injection
[F57Pralidoxime chloride injection]
[F57Pralidoxime mesilate injection]
Promethazine Hydrochloride Injection
Snake Venom Antiserum
Sodium Nitrite Injection
Sodium Thiosulphate Injection
Sterile Pralidoxime
where the administration is for the purpose of saving life in an emergency.
Textual Amendments
F57Words in art. 7 inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 3
7A.—(1) The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration to human beings of smallpox vaccine where the conditions specified in paragraph (2) or (3) are satisfied.
(2) The conditions referred to in this paragraph are—
(a)the vaccine has been supplied by, or on behalf of, or under arrangements made by—
(i)the Secretary of State,
(ii)the Scottish Ministers,
(iii)the National Assembly for Wales,
(iv)the Department of Health, Social Services and Public Safety,
(v)an NHS body; and
(b)the vaccine is administered for the purpose of providing protection against smallpox virus in the event of a suspected or confirmed case of smallpox in the United Kingdom.
(3) The conditions referred to in this paragraph are—
(a)the vaccine has been supplied by, or on behalf of, or under arrangements made by Her Majesty’s Forces;
(b)the vaccine is administered for the purpose of providing protection against smallpox virus to—
(i)members of Her Majesty’s Forces; or
(ii)other persons employed or engaged by those Forces.
(4) For the purposes of this regulation, “NHS body” means—
(a)the Common Services Agency,
(b)a Strategic Health Authority, Health Authority or Special Health Authority,
(c)a Primary Care Trust,
(d)a Local Health Board, or
(e)an NHS trust or NHS foundation trust]
Textual Amendments
F58Art. 7A inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 4
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 [F59, a supplementary prescriber] [F60, 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 [F61, supplementary prescriber] [F62, 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 [F63, supplementary prescriber] [F64, 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 [F65, supplementary prescriber] [F66, 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 [F67a 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
F59Words 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)
F60Words 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)
F61Words 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)
F62Words 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)
F63Words 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)
F64Words 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)
F65Words 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)
F66Words 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)
F67Words 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
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.
10.—[F68(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).
[F69(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
F68Art. 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
F69Art. 10(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 9
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.
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
F70Art. 12 substituted (31.1.2004) by The Prescription Only Medicines (Human Use) Amendment Order 2004 (S.I. 2004/2), arts. 1(1), 2
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 [F72Strategic Health Authority,] Health Authority or Special Health Authority;
(c)an NHS trust [F73or 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 [F74Strategic Health Authority,] Health Authority or Special Health Authority;
(c)an NHS trust [F75or 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
F71Arts. 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)
F72Words 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)
F73Words 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
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 [F76or 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—
[F77(i)in relation to England and Wales, the provision of primary medical services under Part I of the National Health Service Act 1977;]
[F78(ii)in relation to Scotland, the provision of primary medical services under Part I of the National Health Service (Scotland) Act 1978; and]
[F79(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
F71Arts. 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)
F76Words 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
F77Art. 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)
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—
[F80(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);
[F81(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;]
[F82(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 [F83designated 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
F71Arts. 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)
F80Art. 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)
F81Art. 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)
F82Art. 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)
F83Words 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)
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
F84Arts. 12D, 12E inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 11
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
F84Arts. 12D, 12E inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 11
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.
13A.—[F86(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, F87...
(c)a registered midwife, [F88or]
[F89(d)a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—
(i)chiropodists and podiatrists;
(ii)physiotherapists; or
(iii)radiographers: diagnostic or therapeutic,]
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 [F90or supplementary prescriber] where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the extended formulary nurse prescriber [F90or supplementary prescriber] has complied with any condition with which he is required to comply by virtue of [F91articles 3A(2) and (3) or 3B].]
Textual Amendments
F85Art. 13A inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 7
F86Art. 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)
F87Word in art. 13A(1)(b) omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 5(a)
F88Word in art. 13A(1)(c) inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 5(b)
F89Art. 13A(1)(d) inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 5(c)
F90Words 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)
F91Words 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)
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.
[F9215.—(1) For the purposes of section 58(2)(a), and subject to paragraph (3), a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless the conditions specified in paragraph (2) are fulfilled.
(2) The conditions referred to in paragraph (1) are that the prescription—
(a)shall be signed in ink with his own name by the appropriate practitioner giving it;
(b)shall, without prejudice to sub-paragraph (a), be written in ink or otherwise so as to be indelible, unless it is a health prescription which is not for a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, in which case it may be written by means of carbon paper or similar material;
(c)shall contain the following particulars—
(i)the address of the appropriate practitioner giving it,
(ii)the appropriate date,
(iii)such particulars as indicate whether the appropriate practitioner giving it is a doctor, a dentist, a supplementary prescriber, 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, a supplementary prescriber, 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 the address of the person to whom the prescription only medicine is to be delivered and a declaration by the veterinary surgeon or veterinary practitioner giving it that the prescription only medicine is prescribed for an animal or herd under his care;
(d)shall not be dispensed after the end of the period of 6 months from the appropriate date, unless it is a repeatable prescription in which case it shall not be dispensed for the first time after the end of that period nor otherwise than in accordance with the directions contained in the repeatable prescription;
(e)in the case of a repeatable prescription which does not specify the number of times it may be dispensed, shall not be dispensed on more than two occasions unless it is a prescription for an oral contraceptive in which case it may be dispensed 6 times before the end of the period of 6 months from the appropriate date.
(3) For the purposes of paragraph (1) the prescription may, as an alternative to fulfilling the conditions specified in paragraph (2)(a) and (b), fulfil instead the conditions specified in paragraph (4), unless the prescription is a health prescription for a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations or is given by a veterinary surgeon or a veterinary practitioner.
(4) The conditions referred to in paragraph (3) are that the prescription shall be created in electronic form and signed with an advanced electronic signature and transferred to the person by whom it is dispensed as an electronic communication (including where it is so transferred through one or more intermediaries).
(5) The prohibition on sale or supply imposed by section 58(2)(a) shall not apply where a prescription only medicine is sold or supplied other than in accordance with a prescription given by an appropriate practitioner and –
(a)the reason the sale or supply is not in accordance with such a prescription is that a condition specified in paragraph (2) or (4) is not fulfilled; and
(b)the person selling or supplying the prescription only medicine has exercised all due diligence and believes on reasonable grounds that the condition is fulfilled.
(6) In paragraph (2) “appropriate date” means—
(a)in the case of a health prescription, the date on which it was signed by the appropriate practitioner giving it or a date indicated by him as being the date before which it shall not be dispensed; and
(b)in every other case, the date on which the prescription was signed by the appropriate practitioner giving it,
and, for the purposes of sub-paragraphs (d) and (e) of that paragraph, where the health prescription bears both the date on which it was signed and a date indicated as being that before which it shall not be dispensed, the appropriate date is the later of those dates.
(7) In this Article—
“advanced electronic signature” means an electronic signature which is—
uniquely linked to the signatory,
capable of identifying the signatory,
created using means that the signatory can maintain under his sole control, and
which is linked to the data to which it relates in such a manner that any subsequent change of data is detectable;
“electronic communication” means a communication transmitted (whether from one person to another, from one device to another or from a person to a device or vice versa)—
by means of a telecommunication system (within the meaning of the Telecommunications Act 1984, or
by other means but while in an electronic form; and
“signatory” means the appropriate practitioner giving the prescription.]
Textual Amendments
F92Art. 15 substituted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 6
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.
Articles 3(a), 5(1) and 10
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 | |
[F93Acamprosate] | |||||
Acarbose | |||||
Acebutolol Hydrochloride | |||||
[F93Aceclofenac] | |||||
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 | |||||
[F94Adapalene] | |||||
Adenosine | |||||
Adrenaline | (1) By inhaler | ||||
(2) External [F95(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 | |||||
[F93Alendronate Sodium] | |||||
Alfacalcidol | |||||
Alfuzosin Hydrochloride | |||||
Allergen Extracts | |||||
Allopurinol | |||||
Allyloestrenol | |||||
[F96Aloxiprin | (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 | |||||
[F94Altretamine] | |||||
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 | |||||
[F97Amisulpride] | |||||
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 | ||||
[F93Anastrozole] | |||||
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 | |||||
[F94Apraclonidine 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 | |||||
[F98Aspirin | [F99(1) 75mg] | [F99(1) Non-effervescent tablets and capsules] | [F99(1) The quantity sold or supplied in one container or package shall not exceed 100
| ||
[F101(2)] Non-effervescent tablets and capsules | [F101(2)] The quantity sold or supplied in one container or package shall not exceed 32 | ||||
[F101(3)] All preparations other than non-effervescent tablets or capsules |
| ||||
Astemizole | F102. . . | F102. . . | F102. . . | ||
F102. . . | |||||
F102. . . | |||||
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 [F103or perennial allergic rhinitis] | 280mcg per nostril (MDD) | ||||
For use in adults and children not less than [F1045 years] | |||||
As a non-aerosol, aqueous form | |||||
Azidocillin Potassium | |||||
Azithromycin | |||||
Azlocillin Sodium | |||||
Aztreonam | |||||
Bacampicillin Hydrochloride | |||||
Bacitracin | |||||
Bacitracin Methylene Disalicylate | |||||
Bacitracin Zinc | |||||
Baclofen | |||||
[F97Balsalazide 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 [F10520,000 mcg] of Beclomethasone Dipropionate | ||
For the prevention and treatment of allergic rhinitis | 200 mcg per nostril (MDD) | ||||
[F106For a maximum period of 3 months] | |||||
[F107For 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 | |||||
[F97Benserazide] | |||||
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 | |||||
[F94Bicalutamide] | |||||
Biperiden Hydrochloride | |||||
Biperiden Lactate | |||||
Bismuth Glycollylarsanilate | |||||
Bisoprolol Fumarate | |||||
Bleomycin | |||||
Bleomycin Sulphate | |||||
Bretylium Tosylate | |||||
[F97Brimonidine 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 | [F106For a maximum period of 3 months] | ||||
200 mcg per nostril (MDD) | |||||
[F107For 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 | |||||
[F108Cabergoline] | |||||
Calcipotriol | |||||
[F94Calcipotriol Hydrate] | |||||
Calcitonin | |||||
Calcitriol | |||||
Calcium Amphomycin | |||||
Calcium Benzamidosalicylate | |||||
Calcium Bromide | |||||
Calcium Bromidolactobionate | |||||
Calcium Carbimide | |||||
Calcium Folinate | |||||
Calcium Metrizoate | |||||
Calcium Sulphaloxate | |||||
[F109Candesartan Cilexetil] | |||||
Candicidin | |||||
Canrenoic Acid | |||||
Cantharidin | 0.01 per cent | External | |||
Capreomycin Sulphate | |||||
Captopril | |||||
Carbachol | |||||
Carbamazepine | |||||
Carbaryl | |||||
[F97Carbasalate 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 [F110560mg] 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 | |||||
[F97Cefdinir] | |||||
Cefixime | |||||
Cefodizime Sodium | |||||
Cefotaxime Sodium | |||||
Cefoxitin Sodium | |||||
Cefpodoxime Proxetil | |||||
[F108Cefprozil] | |||||
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 | |||||
[F97Cerivastatin Sodium] | |||||
Ceruletide Diethylamine | |||||
Cetirizine Hydrochloride | 10mg (MDD) | F111. . . | |||
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 | |||||
[F94Citalopram 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 | [F1120.05 per cent] | [F112Cream 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)] | [F112Container 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) | |||||
[F93Didanosine] | |||||
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 | |||||
[F96Diphenhydramine Hydrochloride | All preparations except liquid-filled capsules] | ||||
[F113Diphenoxylate Hydrochloride] | [F1132.5 mg] | [F113In combination with Atropine Sulphate for short term use as an adjunctive therapy to appropriate rehydration in acute diarrhoea | [F11325 mg (MDD)] | [F113Container 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 | |||||
[F113Dolasetron Mesilate] | |||||
Domperidone | [F114For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn] | [F11410mg of Domperidone (MD)] | [F114Container or package containing not more than 200mg of Domperidone] | ||
[F11440mg of Domperidone (MDD)] | |||||
Domperidone Maleate | [F115For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn,] | [F11610 mg of Domperidone as Domperidone Maleate (MD)] | [F115Container or package containing not more than [F117200mg] of Domperidone as Domperidone Maleate;] | ||
[F11640 mg of Domperidone as Domperidone Maleate (MDD)] | |||||
[F97Donepezil Hydrochloride] | |||||
Dopamine Hydrochloride | |||||
Dopexamine Hydrochloride | |||||
[F94Dorzolamide 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 | |||||
[F93Eformoterol 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 | |||||
[F118Estramustine 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 | |||||
[F94Exemestane] | |||||
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 [F11950g] of medicinal product | |
[F120For 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 | [F112External use (but in the case of vaginal use, only for the treatment of vaginal candidiasis)] | ||||
Feprazone | |||||
Ferrous Arsenate | |||||
[F94Ferumoxsil] | |||||
[F97Fexofenadine 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 [F121or 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) | |||||
[F122For use in persons aged 18 years and over] | [F123For a maximum period of 3 months] | ||||
In the form of a non-pressurised nasal spray | |||||
F124... | F124... | F124... | |||
F124. . . | |||||
F124. . . | |||||
F124. . . | |||||
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 | [F1258.75 mg] | [F126Throat lozenges] | [F12743.75 mg (MDD)] | [F128Container or package containing not more than 140 mg of Flurbiprofen] | |
Flurbiprofen Sodium | |||||
Fluspirilene | |||||
Flutamide | |||||
Fluticasone Propionate | |||||
[F97Flutrimazole] | |||||
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 | [F129(1) 0.5 per cent] | [F129(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] | [F129(1) Container or package containing not more than 15g of medicinal product] | ||
[F130(2)] 1.0 per cent | [F130(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 [F131or 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 | [F130(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 [F132or 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 | |||||
[F96Hydrocyanic 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 | ||||
[F133(3) 10.0 per cent] | [F133(3) External] | [F133(3) 125 mg (MD) 500 mg (MDD)] | [F133(3) Container or package containing not more than [F13450g] of medicinal product] | ||
[F96Ibuprofen 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 | |||||
[F93Imidapril Hydrochloride] | |||||
Imipenem Hydrochloride | |||||
Imipramine | |||||
Imipramine Hydrochloride | |||||
Imipramine Ion Exchange Resin Bound Salt or Complex | |||||
[F108Indapamide] | |||||
Indapamide Hemihydrate | |||||
Indomethacin | |||||
Indomethacin Sodium | |||||
Indoprofen | |||||
Indoramin Hydrochloride | |||||
Inosine Pranobex | |||||
[F135Insulin] | |||||
Iodamide | |||||
Iodamide Meglumine | |||||
Iodamide Sodium | |||||
Iohexol | |||||
Iomeprol | |||||
Iopamidol | |||||
Iopentol | |||||
Iothalamic Acid | |||||
Ioversol | |||||
Ioxaglic Acid | |||||
Ipratropium Bromide | |||||
Iprindole Hydrochloride | |||||
Iproniazid Phosphate | |||||
[F97Irbesartan] | |||||
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 | [F136(a)] [F137External] | [F136(a)] Maximum frequency of application of once every 3 days | [F136(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 | |||||
[F138(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 | |||||
[F108Lansoprazole] | |||||
Latamoxef Disodium | |||||
[F108Lercanidipine Hydrochloride] | |||||
Levallorphan Tartrate | |||||
Levobunolol Hydrochloride | |||||
[F96Levocabastine 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 | |||||
[F139Levocarnitine] | [F139For dietary supplementation] | ||||
Levodopa | |||||
[F97Levofloxacin] | |||||
Levonorgestrel | [F1400.75mg] | [F140for 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 | [F141equivalent of 0.1 per cent Lodoxamide] | [F142For 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) | F143. . . | |||
[F109Lornoxicam] | |||||
[F109Losartan 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 | [F144(a) For the symptomatic relief of irritable bowel syndrome | [F144(a) 135 mg (MD) 405 mg (MDD)] | |||
(b) For uses other than the symptomatic relief of irritable bowel syndrome] | [F144(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 | |||||
[F108Meloxicam] | |||||
Melphalan | |||||
Melphalan Hydrochloride | |||||
Menotrophin | |||||
Mepenzolate Bromide | 25mg (MD) | ||||
75mg (MDD) | |||||
Mephenesin | |||||
Mephenesin Carbamate | |||||
Mepivacaine Hydrochloride | Any use except ophthalmic use | ||||
Meptazinol Hydrochloride | |||||
Mequitazine | |||||
[F97Mercaptamine 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 | [F145(1) 2.0 per cent] | [F145(1) External | |||
[F145(2) 5.0 per cent | (2) External use for the treatment of alopecia androgenetica, in men aged 18 to 65 (but not in women);] | ||||
[F93Mirtazapine] | |||||
Misoprostol | |||||
Mitobronitol | |||||
Mitomycin | |||||
Mitozantrone Hydrochloride | |||||
Mivacurium Chloride | |||||
[F118Mizolastine] | |||||
Moclobemide | |||||
[F97Modafinil] | |||||
[F94Moexipril Hydrochloride] | |||||
Molgramostim | |||||
Molindone Hydrochloride | |||||
Mometasone Furoate | |||||
Moracizine Hydrochloride | |||||
Morazone Hydrochloride | |||||
[F93Moxonidine] | |||||
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 | |||||
[F97Naratriptan Hydrochloride] | |||||
Natamycin | |||||
[F109Nebivolol Hydrochloride] | |||||
Nedocromil Sodium | [F1462.0 per cent] | [F146For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis] | [F146Container 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 | |||||
[F118Niceritrol] | |||||
Nicotinic Acid | Any use, except for the treatment of hyperlipidaemia | 600mg (MDD) | |||
Nicoumalone | |||||
Nifedipine | |||||
Nifenazone | |||||
Nikethamide | |||||
[F96Nilutamide] | |||||
Nimodipine | |||||
Niridazole | |||||
[F109Nisoldipine] | |||||
Nitrendipine | |||||
Nitrofurantoin | |||||
Nitrofurazone | |||||
Nizatidine | For the prevention [F147and treatment] of the symptoms of food-related heartburn [F147and meal-induced indigestion] | 75mg (MD) | |||
[F148150mg (MDD)] | |||||
[F149For 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 | [F1503.0 per cent] | [F150External | [F150Container 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 | |||||
[F93Omeprazole 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 | |||||
[F108Pantoprazole 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) | |||||
[F98Paracetamol | (1) [F151250mg] | (1) Non-effervescent tablets and capsules [F152wholly 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
| ||
(2) 500 mg | (2) Non-effervescent tablets and capsules [F153wholly 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
| ||||
Paraldehyde | |||||
Paramethadione | |||||
Paramethasone Acetate | |||||
Parathyroid Gland | |||||
Pargyline Hydrochloride | |||||
Paroxetine Hydrochloride | |||||
Pecilocin | |||||
Penamecillin | |||||
Penbutolol Sulphate | |||||
[F108Penciclovir] | |||||
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 | |||||
[F154Phenolphthalein.] | |||||
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 | |||||
[F96Phytomenadione | 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 | |||||
[F155Pirenzepine 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 | |||||
[F118Piroxicam 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 | |||||
[F97Pramipexole 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 | [F1123mg] | [F112Buccal tablets for the treatment of nausea and vomiting in cases of previously diagnosed migraine only. For use in persons aged 18 years and over.] | [F11212mg (MDD)] | [F112Container 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) | |||||
[F109Propiverine 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 | |||||
[F109Quetiapine Fumarate] | |||||
[F94Quinagolide Hydrochloride] | |||||
Quinapril | |||||
[F155Quinapril 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 | |||||
[F93Ranitidine Bismuth Citrate] | |||||
Ranitidine Hydrochloride | For the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity [F156or 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 | |||||
[F97Reboxetine Mesilate] | |||||
Remoxipride Hydrochloride | |||||
Reproterol Hydrochloride | |||||
Rescinnamine | |||||
Reserpine | |||||
Rifabutin | |||||
Rifampicin | |||||
Rifampicin Sodium | |||||
Rifamycin | |||||
[F93Rimexolone] | |||||
Rimiterol Hydrobromide | |||||
Risperidone | |||||
Ritodrine Hydrochloride | |||||
Rolitetracycline Nitrate | |||||
[F113Ropinirole Hydrochloride] | |||||
Sabadilla | |||||
Salbutamol | |||||
Salbutamol Sulphate | |||||
Salcatonin | |||||
Salcatonin Acetate | |||||
Salmefamol | |||||
Salmeterol Xinafoate | |||||
Salsalate | |||||
Saralasin Acetate | |||||
Selegiline Hydrochloride | |||||
Semisodium Valproate | |||||
[F97Sertindole] | |||||
[F93Sertraline Hydrochloride] | |||||
Serum Gonadotrophin | |||||
[F93Sevoflurane] | |||||
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 [F157or 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 | |||||
[F94Sparfloxacin] | |||||
Spectinomycin | |||||
Spectinomycin Hydrochloride | |||||
Spiramycin | |||||
Spiramycin Adipate | |||||
Spironolactone | |||||
Stannous Fluoride | ([F1581]) 0.62 per cent | ([F1581]) Dentifrice | |||
[F158(2) 0.4 per] | [F158(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 | |||||
[F96Strychnine Nitrate] | |||||
Styramate | |||||
Succinylsulphathiazole | |||||
Sucralfate | |||||
Sulbactam Sodium | |||||
Sulbenicillin | |||||
Sulbenicillin Sodium | |||||
Sulconazole Nitrate | External (except vaginal) | ||||
[F96Sulfabenzamide] | |||||
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 | |||||
[F109Tacalcitol Monohydrate] | |||||
Tacrine Hydrochloride | |||||
Talampicillin | |||||
Talampicillin Hydrochloride | |||||
Talampicillin Napsylate | |||||
Tamoxifen | |||||
Tamoxifen Citrate | |||||
[F108Tamsulosin Hydrochloride] | |||||
[F93Tazarotene] | |||||
Tazobactam Sodium | |||||
Teicoplanin | |||||
[F97Temocapril Hydrochloride] | |||||
Temocillin Sodium | |||||
Tenoxicam | |||||
Terazosin Hydrochloride | |||||
Terbinafine | [F1591.0 per cent] | [F160External use for the treatment of tinea pedis, tinea cruris and tinea corporis. In the form of a gel] | [F161Container or package containing not more than 30 grams of medicinal product] | ||
[F162Terbinafine Hydrochloride] | [F1621.0 per cent] | ([F1631]) [F164Preparations, other than spray solutions, for] [F162external use for the treatment of tinea pedis and tinea cruris] | ([F1631]) [F162Container or package containing not more than 15 g of medicinal product.] | ||
[F165(2) Spray solutions for external use for the treatment of tinea corporis, tinea cruris and tinea pedis] | [F165(2) Container containing not more than 30ml of medicinal product] | ||||
Terbutaline | |||||
Terbutaline Sulphate | |||||
Terfenadine | F166. . . | F166... | |||
Terlipressin | |||||
Terodiline Hydrochloride | |||||
[F97Testosterone] | |||||
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 | |||||
[F108Ticlopidine Hydrochloride] | |||||
Tigloidine Hydrobromide | |||||
[F108Tiludronate Disodium] | |||||
Timolol Maleate | |||||
Tinidazole | |||||
Tinzaparin | |||||
Tioconazole | (1) 2.0 per cent | (1) External (except vaginal) | |||
(2) Vaginal for treatment of vaginal candidiasis | |||||
[F94Tizanidine Hydrochloride] | |||||
Tobramycin | |||||
Tobramycin Sulphate | |||||
Tocainide Hydrochloride | |||||
Tofenacin Hydrochloride | |||||
Tolazamide | |||||
Tolazoline Hydrochloride | External | ||||
Tolbutamide | |||||
Tolbutamide Sodium | |||||
Tolfenamic Acid | |||||
Tolmetin Sodium | |||||
[F93Topiramate] | |||||
[F118Torasemide] | |||||
[F108Toremifene] | |||||
Tramadol Hydrochloride | |||||
Trandolapril | |||||
Tranexamic Acid | |||||
Tranylcypromine Sulphate | |||||
Trazodone Hydrochloride | |||||
Treosulfan | |||||
Tretinoin | |||||
Triamcinolone | |||||
Triamcinolone Acetonide | [F167(1)] 0.1 per cent | [F167(1)] For the treatment of common mouth ulcers | [F167(1)] Container or package containing not more than 5g of medicinal product | ||
[F168(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] | [F168(2) 110mcg per nostril (MD) | [F168Container 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) | |||||
[F94Valaciclovir Hydrochloride] | |||||
Valproic Acid | |||||
[F97Valsartan] | |||||
Vancomycin Hydrochloride | |||||
Vasopressin | |||||
Vasopressin Tannate | |||||
Vecuronium Bromide | |||||
[F94Venlafaxine 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 | |||||
[F94Zalcitabine] | |||||
Zidovudine | |||||
Zimeldine Hydrochloride | |||||
Zolpidem Tartrate | |||||
Zomepirac Sodium | |||||
Zopiclone | |||||
Zuclopenthixol Acetate | |||||
Zuclopenthixol Decanoate | |||||
Zuclopenthixol Hydrochloride] |
Textual Amendments
F93Words 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)
F94Words 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)
F95Words 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)
F96Words 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.
F97Sch. 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)
F98Words 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
F99Words 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)
F100Words 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)
F101Sch. 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)
F102Words 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)
F103Words 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)
F104Words 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)
F105Word 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)
F106Words 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)
F107Words 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)
F108Words 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)
F109Words 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)
F110Word 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)
F111Words 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)
F112Sch. 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)
F113Sch. 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)
F114Sch. 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)
F115Words 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)
F116Words 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)
F117Words 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)
F118Words 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)
F119Word 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)
F120Words 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)
F121Words 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)
F122Words 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)
F123Words 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)
F124Words 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)
F125Words 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)
F126Words 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)
F127Words 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)
F128Words 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)
F129Words 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)
F130Sch. 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)
F131Words 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)
F132Words 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)
F133Words 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)
F134Words 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)
F135Word 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)
F136Word 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)
F137Words 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)
F138Words 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)
F139Words 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)
F140Sch. 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
F141Words 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)
F142Words 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)
F143Words 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)
F144Words 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)
F145Words 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)
F146Words 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)
F147Words 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)
F148Words 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)
F149Words 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)
F150Words 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)
F151Words 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)
F152Words 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)
F153Words 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)
F154Words 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)
F155Words 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)
F156Words 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)
F157Words 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)
F158Sch. 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)
F159Words 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)
F160Words 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)
F161Words 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)
F162Words 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)
F163Sch. 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)
F164Words 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)
F165Sch. 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)
F166Words 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)
F167Sch. 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)
F168Sch. 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
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)
[F169Co-danthramer Capsules NPF]
[F169Co-danthramer Capsules, Strong NPF]
Co-danthramer-Oral Suspension NPF
Co-danthramer-Oral Suspension Strong NPF
Co-danthrusate Capsules
[F169Co-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
[F170Water for Injections]
Textual Amendments
F169Words in Sch. 3 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 4
F170Words 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
Textual Amendments
F171Sch. 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 |
[F172Acetylcysteine | Parenteral] |
Aciclovir | External use |
Acrivastine | Oral |
Adapalene | External use |
[F172Adrenaline | Parenteral] |
Alclometasone dipropionate | External use |
Alimemazine tartrate (trimeprazine tartrate) | Oral |
[F172Alteplase | Parenteral] |
[F172Amiodarone | Parenteral] |
[F173Amitriptyline hydrochloride | Oral [F174administration in palliative care]] |
Amorolfine hydrochloride | External use |
Amoxycillin trihydrate | Oral |
Aspirin | Oral |
Azelaic acid | External use |
Azelastine hydrochloride | Ophthalmic use or nasal |
[F173Azithromycin dihydrate | Oral] |
Baclofen | Oral administration in palliative care |
Beclometasone dipropionate | External use or nasal [F175inhalation] |
[F172Bemiparin sodium | Parenteral] |
[F172Benzatropine mesilate | Parenteral] |
Betamethasone dipropionate | External use |
Betamethasone sodium phosphate | Aural or nasal |
Betamethasone valerate | External use |
Budesonide | Nasal [F176inhalation] |
[F172Calcipotriol | External] |
[F172Calcitriol | External] |
[F173Carbamazepine | Oral or rectal [F177administration in palliative care]] |
Carbaryl | External use |
Carbenoxolone sodium | Mouthwash |
[F172Cefotaxime sodium | Parenteral] |
[F172Ceftriaxone Sodium | Parenteral] |
[F172Certoparin sodium | Parenteral] |
Cetirizine hydrochloride | Oral |
[F172Chlorphenamine maleate | Parenteral] |
Chloramphenicol | Ophthalmic use |
Cimetidine | Oral |
[F172Cimetidine | Parenteral] |
Cinchocaine hydrochloride | External use |
[F173Clavulanic acid [F178(as potassium clavulanate)] | Oral] |
Clindamycin phosphate | External use |
Clobetasone butyrate | External use |
Clotrimazole | External use |
[F179Codeine Phosphate | Oral] |
[F173Conjugated oestrogens (equine) | External use] |
[F179Co-Phenotrope | Oral] |
F180. . . | F180. . . |
[F172Cyclizine hydrochloride | Oral] |
[F172Cyclizine lactate | Parenteral] |
[F172Dalteparin sodicum | Parenteral] |
Dantrolene sodium | Oral administration in palliative care |
Dantron | Oral |
Desogestrel | Oral |
Desoximetasone (Desoxymethasone) | External use |
Dexamethasone | Aural |
Dexamethasone isonicotinate | Nasal |
[F172Dexamethasone sodium phosphate | Oral] |
[F172Dextran 70 | Parenteral] |
[F179Diazepam | Oral, parenteral or rectal administration F181...] |
Diclofenac diethylammonium | External use |
[F173Diclofenac potassium | Oral] |
[F173Diclofenac sodium | Oral F182... rectal [F183or ophthalmic]] |
[F179Dihydrocodeine Tartrate | Oral] |
[F172Dolesetron mesilate | Oral and parenteral] |
Domperidone | Oral or rectal administration F184... |
Domperidone maleate | Oral administration F185... |
Doxycycline [F186hyclate] | Oral |
[F187Doxycycline monohydrate | Oral] |
Econazole nitrate | External use |
[F187Emedastine | Ophthalmic use] |
[F172Enoxaparin | Parenteral] |
Erythromycin | External use [F188or oral] |
[F173Erythromycin ethyl succinate | Oral] |
[F173Erythromycin stearate | Oral] |
[F173Estradiol | External use] |
[F173Estriol | External use] |
Ethinylestradiol | Oral |
[F173Etonogestrel | Implant] |
Etynodiol diacetate (ethynodiol diacetate) | Oral |
Famotidine | Oral |
Felbinac | External use |
Fenticonazole nitrate | External use |
Fexofenadine hydrochloride | Oral |
[F187Flucloxacillin magnesium | Oral] |
Flucloxacillin sodium | Oral [F189or parenteral] |
Fluconazole | Oral |
Fludroxycortide (Flurandrenolone) | External use |
[F173Flumazenil | 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 |
[F172Furosemide | Oral and parenteral] |
Fusidic acid | [F190External Use] |
[F173Gabapentin | Oral [F191administration in palliative care]] |
[F172Gelatin 3.5 – 4% | Parenteral] |
Gentamicin sulphate | Aural |
Gestodene | Oral |
[F173Glucagon hydrochloride | Parenteral] |
[F173Glucose | Parenteral] |
[F172Glucose 5% | Parenteral] |
[F172Glucose 5% with Potassium (K+ 40 mmol/L) ready made infusion bag | Parenteral] |
[F172Granisetron hydrochloride | Parenteral] |
[F172Heparin sodium | Parenteral for the purpose of cannulae flushing] |
[F172Hexastarch | Parenteral] |
[F172Human soluble insulin | Parenteral] |
Hydrocortisone | External use |
Hydrocortisone acetate | External use [F192or aural] |
Hydrocortisone butyrate | External use |
Hydrocortisone sodium succinate | Lozenges [F193or parenteral] |
[F172Hydroxyethl starch | Parenteral] |
[F194Hyoscine | Transdermal administration in palliative care] |
Hyoscine butylbromide | Parenteral F195... administration in palliative care |
Hyoscine hydrobromide | [F196Oral or parenteral administration in palliative care] |
Ibuprofen | External use or oral |
Ibuprofen lysine | Oral |
[F173Imipramine hydrochloride | Oral [F197administration in palliative care]] |
Ipratropium bromide | Nasal [F198inhalation] |
Isotretinoin | External use |
Ketoconazole | External use |
Ketoprofen | External use |
Levocabastine hydrochloride | Ophthalmic use or nasal |
[F172Levomepromazine | Oral and parenteral] |
Levomepromazine (methotrimeprazine) maleate | Oral administration in palliative care |
Levomepromazine (methotrimeprazine) hydrochloride | Parenteral administration in palliative care |
Levonorgestrel | Oral |
[F173Lignocaine hydrochloride | External use or parenteral] |
Lithium succinate | External use |
Lodoxamide trometamol | Ophthalmic use |
Loperamide hydrochloride | Oral |
Loratadine | Oral |
[F179Lorazepam | Oral or parenteral administration F199...] |
[F173Lymecycline | Oral] |
Mebendazole | Oral |
Medroxyprogesterone acetate | Parenteral |
Mestranol | Oral |
Metoclopramide hydrochloride | Oral or parenteral administration F200... |
Metronidazole | [F201External use, oral or rectal] |
Metronidazole benzoate | Oral |
Miconazole | Dental lacquer |
Miconazole nitrate | External use |
[F179Midazolam | Parenteral administration F202...] |
Minocycline | Oral |
[F187Mizolastine | Oral] |
[F187Minocycline hydrochloride | Oral |
Mometasone furoate | External use or nasal |
[F172Naloxone | Parenteral] |
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 |
[F173Nortriptyline hydrochloride | Oral [F203administration in palliative care]] |
Nystatin | External use |
[F172Omeprazole | Oral] |
[F172Omeprazole sodium | Parenteral] |
[F172Ondansetron Hydrochloride | Oral and parenteral] |
[F172Oxbuprocaine hydrochloride | Ophalmic] |
Oxytetracycline dihydrate | Oral |
Paracetamol | Oral |
Penciclovir | External use |
[F172Pentastarch | Parenteral] |
Piroxicam | External use |
[F173Prednisolone | Oral] |
Prednisolone hexanoate | External use |
Prednisolone sodium phosphate | Aural [F204or oral] |
[F172Prilocaine | External and parenteral] |
[F172Prochlorperazine maleate | Oral, rectal and buccal] |
[F172Prochlorperazine mesilate | Oral and rectal] |
[F172Proxymetacaine hydrochloride | Ophthalmic] |
Ranitidine hydrochloride | Oral [F205or parenteral] |
[F172Reteplase | Parenteral] |
[F173Salbutamol sulphate | Inhalation] |
Silver sulphadiazine | External use |
[F172Sodium chloride 0.9% | Parental, for reconstitution of injections and for the purpose of cannulae flushing] |
[F172Sodium chloride 0.9% & Glucose 5% ready made infusion bag | Parenteral] |
[F172Sodium chloride 0.45% & Glucose 5% ready made infusion bag ] | |
[F172Sodium chloride 0.9% with Potassium (K+ 40 mmol/L) ready made infusion bag | Parenteral] |
[F172Sodium chloride 0.45% and Glucose 5% with Potassium 20mmol per 500 ml ready made infusion bag | Parenteral] |
Sodium cromoglycate | Ophthalmic use |
[F173Sodium fusidate | External use] |
Streptodornase | External use |
Streptokinase | External use |
[F172Streptokinase | Parenteral] |
Sulconazole nitrate | External use |
[F172Tacalcitol | External] |
[F172Tenecteplase | Parenteral] |
[F172Tetanus immunoglobulin | Parenteral] |
Terbinafine hydrochloride | External use |
[F173Terbutaline sulphate | Inhalation] |
[F172Tetracaine | External] |
Tetracycline hydrochloride | External use or oral |
[F172Tinzaparin sodium | Parenteral] |
Tretinoin | External use |
Triamcinolone acetonide | External use, aural, nasal or oral paste |
Trimethoprim | Oral |
[F172Tropicamide | Ophthalmic] |
[F172Tropisetron hydrochloride | Parenteral] |
Tuberculin PPD | Parenteral |
[F172Unfractionated Heparin | 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 |
[F172Vaccine – Combined Tetanus, diphtheria, acullular pertussis, inactivated poliomyelitis and haemophilus influenza type B | 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 |
[F172Vaccine – Inactivated Poliomyelitis | 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 |
[F172Vaccine – Meningococcal Polysaccharide A, C, W135 and Y | Parenteral] |
Vaccine, Pneumococcal | Parenteral |
F206. . . | F206. . . |
Vaccine, Poliomyelitis, Live (Oral) | Oral |
Vaccine, Rubella, Live | Parenteral |
Vaccine, Tetanus, Adsorbed | Parenteral |
Vaccine, Typhoid, Live Attenuated (Oral) | Oral |
Vaccine, Typhoid, Polysaccharide | Parenteral |
[F187Water for Injections | Parenteral]] |
Textual Amendments
F172Words in Sch. 3A inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(a)
F173Sch. 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)
F174Words in Sch. 3A inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 5(a)
F175Words in Sch. 3A added (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(b)
F176Words in Sch. 3A added (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(c)
F177Words in Sch. 3A inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 5(b)
F178Words 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)
F179Words 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
F180Words in Sch. 3A omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(d)
F181Words in Sch. 3A omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(e)
F182Word in Sch. 3A omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(f)
F183Word in Sch. 3A added (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(f)
F184Words in Sch. 3A omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(g)
F185Words in Sch. 3A omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(h)
F186Words 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)
F187Words 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)
F188Words 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)
F189Words in Sch. 3A added (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(i)
F190Words 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)
F191Words in Sch. 3A inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 5(c)
F192Words 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)
F193Words in Sch. 3A added (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(j)
F194Words 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)
F195Words 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)
F196Words 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)
F197Words in Sch. 3A inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 5(d)
F198Words in Sch. 3A added (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(k)
F199Words in Sch. 3A omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(l)
F200Words in Sch. 3A omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(m)
F201Words 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)
F202Words in Sch. 3A omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(n)
F203Words in Sch. 3A inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 5(e)
F204Words 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)
F205Words in Sch. 3A inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 7(o)
F206Words 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)
Textual Amendments
F207Sch. 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)
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)
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–
| 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 | 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. |
[F21210. F213... 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 [F214or 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
F208Word 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)
F209Words in Sch. 5 Pt. 1 para. 5 omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 8(a)
F210Words in Sch. 5 Pt. 1 para. 5 inserted (7.4.2005) by The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 8(b)
F211Words in Sch. 5 Pt. 1 omitted (7.4.2005) by virtue of The Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765), arts. 1(1), 8(c)
F212Sch. 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.
F213Word 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)
F214Words 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)
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)
Column 1 | Column 2 | Column 3 |
---|---|---|
Persons exempted | Prescription only medicines to which the exemption applies | Conditions |
1. F215... registered chiropodists who hold a certificate of competence in the use of analgesics issued by or with the approval of the Chiropodists Board [F216or 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–
| 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– | 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 [F220or persons who are [F221registered] 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) [F222medicines 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–
| 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
F215Word 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)
F216Words 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)
F217Words 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)
F218Words 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)
F219Words 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
F220Words 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)
F221Word 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)
F222Words 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)
F223Word in Sch. 5 Pt. 3 para. 9 inserted (19.11.2004) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004 (S.I. 2004/2693), arts. 1(1), 6
F224Words 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)
F225Words 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
F226Words 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)
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
Textual Amendments
F227Sch. 7 inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(e)
(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.
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 |
[F228Strategic Health Authority] | [F228The Strategic Health Authority] |
Health Authority | The Health Authority |
Special Health Authority | The Special Health Authority |
NHS trust [F229or 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, [F230, 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 [F231or NHS foundation trust] or Primary Care Trust with which the arrangement has been made] |
Textual Amendments
F228Words 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)
F229Words 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
Textual Amendments
F232Sch. 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] |
Textual Amendments
F233Words 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)
[F234Registered 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.
F235...
Registered midwives.
Registered nurses.
Registered ophthalmic opticians.
[F236Registered] chiropodists.
[F237Registered orthoptists.
Registered physiotherapists.
Registered radiographers.]
[F238Registered dietitians.]
[F238Registered occupational therapists.]
[F238Registered orthotists and prosthetists.]
[F238Registered speech and language therapists.]]
Textual Amendments
F234Words 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)
F235Words 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)
F236Word 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)
F237Words 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)
F238Words 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
(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.
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.
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).
1971 c. 61; section 1 was substituted by section 24 of the Oil and Gas (Enterprise) Act 1982 (c. 23).
S.I. 1980/1923, amended by S.I. 1997/1831.
See S.I. 1979/382 amended by S.I. 1980/263 and S.I. 1989/1124.