Changes over time for: The Prescription Only Medicines (Human Use) Order 1997

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Statutory Instruments

1997 No. 1830

MEDICINES

The Prescription Only Medicines (Human Use) Order 1997

Made

25th July 1997

Laid before Parliament

28th July 1997

Coming into force

18th August 1997

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

Citation, commencement and interpretation

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

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

F1...

F2...

F1...

F3...

F1...

F4...

F5...

F1...

F6...

F1...

“inhaler” does not include an aerosol;

F1...

“maximum strength” means–

(a)

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

(b)

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

(i)

weight in weight,

(ii)

weight in volume,

(iii)

volume in weight, or

(iv)

volume in volume,

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

F1...

F7...

F1...

[F8(2A) In this Order, unless the context otherwise requires, any expression defined by any provision of the Human Medicines Regulations 2012 has the same meaning as it has for the purposes of 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 [F9Schedules 1 and 2]–

(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.

F10(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F10(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F10(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F10(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1Words in art. 1(2) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 71(2)(a) (with Sch. 32)

F2Words 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)

F3Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(b)

F4Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(c)

F5Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(d)

F6Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(e)

F7Words 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)

F8Art. 1(2A) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 71(2)(b) (with Sch. 32)

F9Words in art. 1(5) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 71(2)(c) (with Sch. 32)

F10Art. 1(6)-(9) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 71(2)(d), Sch. 35 (with Sch. 32)

Appropriate practitioners

F112. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11Arts. 2-4 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Medicinal products on prescription only

F113. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11Arts. 2-4 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Prescribing and administration by nurse independent prescribers

F113A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11Arts. 2-4 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Prescribing and administration by supplementary prescribers

F113B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11Arts. 2-4 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

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

F113C. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11Arts. 2-4 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Duration of special provisions in relation to new medicinal products

F114. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11Arts. 2-4 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Exempt medicinal products

5.—(1) [F12A medicinal product that is not the subject of a marketing authorisation is a prescription only medicine for the purposes of the Human Medicines Regulations 2012 if it, or a substance in it, is listed in column 1 of Schedule 1, unless 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 [F13,

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

F12Words in art. 5(1) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 71(3) (with Sch. 32)

F13Words 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

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

F145A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F14Arts. 5A-9 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

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

F145B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F14Arts. 5A-9 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

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

F146. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F14Arts. 5A-9 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

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

F147. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F14Arts. 5A-9 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Exemptions for administration of smallpox vaccine

F147A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F14Arts. 5A-9 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Exemption for administration by operators

F117B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11Arts. 2-4 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Exemptions for emergency sale or supply

F148. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F14Arts. 5A-9 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Exemption for non-parenteral administration to human beings

F149. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F14Arts. 5A-9 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Exemption for medicinal products at high dilutions

10.—[F15(1)] [F16A medicinal product is not a prescription only medicine for the purposes of the Human Medicines Regulations 2012 by virtue of Article 5(1) if it is] 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 [F17or in Schedule 2], only one or more unit preparation of such substances, if–

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

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

[F18(2) [F16A medicinal product is not a prescription only medicine for the purposes of the Human Medicines Regulations 2012 by virtue of Article 5(1) if it is] 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

F15Art. 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

F16Words in art. 10(1)(2) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 71(4) (with Sch. 32)

F17Words in art. 10(1) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 8

F18Art. 10(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 9

Exemptions for certain persons

F1911. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Exemption for sale or supply in hospitals

F1912. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

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

F1912A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

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

F1912B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

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

F1912C. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

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

F1912D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

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

F1912E. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

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

F1912F. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Exemption in cases involving another’s default

F1913. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Exemptions relating to prescriptions given by certain health professionals

F1913A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Exemption in the case of a forged prescription

F1914. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Prescriptions

F1915. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Revocations

F1916. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19Arts. 11-16 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Signed by authority of the Secretary of State for Health

Baroness Jay

Minister of State,

Department of Health

Win Griffiths

Parliamentary Under Secretary of State, Welsh Office

Sam Galbraith

Parliamentary Under Secretary of State, The Scottish Office

Jeff Rooker

Minister of State, Ministry of Agriculture, Fisheries and Food

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

D. C. Gowdy

Permanent Secretary

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

P. Small

Permanent Secretary

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

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

	Exemptions from the restrictions on the sale and supply of prescription only medicines
Column 1	Column 2	Column 3	Column 4	Column 5
Substance	Maximum strength	Route of administration, use or pharmaceutical form	Treatment limitations	Maximum quantity
[F20Acamprosate]
Acarbose
Acebutolol Hydrochloride
[F20Aceclofenac]
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
Aciclovir	5.0 per cent	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
[F21Adapalene]
Adenosine
Adrenaline		(1) By inhaler
Adrenaline		(2) External [F22(except ophthalmic)]
Adrenaline Acid Tartrate		(1) By inhaler
Adrenaline Acid Tartrate		(2) External
Adrenaline Hydrochloride		(1) By inhaler
Adrenaline Hydrochloride		(2) External
Adrenocortical Extract
Albendazole
Alclofenac
Alclometasone Dipropionate
Alcuronium Chloride
Aldesleukin
Aldosterone
[F20Alendronate Sodium]
Alfacalcidol
Alfuzosin Hydrochloride
Allergen Extracts
Allopurinol
Allyloestrenol
[F23Aloxiprin	(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
[F21Altretamine]
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
[F24Amisulpride]
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
[F20Anastrozole]
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
[F21Apraclonidine 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
[F25Aspirin	[F26(1) 75mg]	[F26(1) Non-effervescent tablets and capsules]		[F26(1) The quantity sold or supplied in one container or package shall not exceed 100 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100]
	[F27[F28(2)] 500 mg]	[F28(2)] Non-effervescent tablets and capsules		[F28(2)] The quantity sold or supplied in one container or package shall not exceed 32
	[F27[F28(2)] 500 mg]	[F28(3)] All preparations other than non-effervescent tablets or capsules		The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100]
Astemizole		F29. . .	F29. . .	F29. . .
		F29. . .
		F29. . .
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 [F30or perennial allergic rhinitis]	280mcg per nostril (MDD)
		For use in adults and children not less than [F315 years]
		As a non-aerosol, aqueous form
Azidocillin Potassium
Azithromycin
Azlocillin Sodium
Aztreonam
Bacampicillin Hydrochloride
Bacitracin
Bacitracin Methylene Disalicylate
Bacitracin Zinc
Baclofen
[F24Balsalazide 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 [F3220,000 mcg] of Beclomethasone Dipropionate
			100mcg per nostril (MD)

		For the prevention and treatment of allergic rhinitis	200 mcg per nostril (MDD)
		For the prevention and treatment of allergic rhinitis	[F33For a maximum period of 3 months]
		[F34For use in persons aged 18 years and over]
Belladonna Herb		(1) Internal	(1) 1mg of the alkaloids (MDD)
Belladonna Herb		(2) External
Belladonna Root		(1) Internal	(1) 1mg of the alkaloids (MDD)
Belladonna Root		(2) External
Bemegride
Bemegride Sodium
Benapryzine Hydrochloride
Bendrofluazide
Benethamine Penicillin
Benoxaprofen
Benperidol
[F24Benserazide]
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
[F21Bicalutamide]
Biperiden Hydrochloride
Biperiden Lactate
Bismuth Glycollylarsanilate
Bisoprolol Fumarate
Bleomycin
Bleomycin Sulphate
Bretylium Tosylate
[F24Brimonidine 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	[F33For a maximum period of 3 months]
		200 mcg per nostril (MDD)	[F33For a maximum period of 3 months]
		[F34For use in persons aged 18 years and over]
		As a non-aerosol, aqueous form
Bufexamac
Bumetanide
Buphenine Hydrochloride			6mg (MD)
Buphenine Hydrochloride			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
[F35Cabergoline]
Calcipotriol
[F21Calcipotriol Hydrate]
Calcitonin
Calcitriol
Calcium Amphomycin
Calcium Benzamidosalicylate
Calcium Bromide
Calcium Bromidolactobionate
Calcium Carbimide
Calcium Folinate
Calcium Metrizoate
Calcium Sulphaloxate
[F36Candesartan Cilexetil]
Candicidin
Canrenoic Acid
Cantharidin	0.01 per cent	External
Capreomycin Sulphate
Captopril
Carbachol
Carbamazepine
Carbaryl
[F24Carbasalate Calcium]
Carbenicillin Sodium
Carbenoxolone Sodium		(1) Pellet	(1) 5mg (MD)
		(1) Pellet	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 [F37560mg] of Carbenoxolone Sodium
	(3) 1.0 per cent		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
[F24Cefdinir]
Cefixime
Cefodizime Sodium
Cefotaxime Sodium
Cefoxitin Sodium
Cefpodoxime Proxetil
[F35Cefprozil]
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
[F24Cerivastatin Sodium]
Ceruletide Diethylamine
Cetirizine Hydrochloride			10mg (MDD)	F38. . .
Chenodeoxycholic Acid
Chloral Hydrate		External
Chlorambucil
Chloramphenicol
Chloramphenicol Cinnamate
Chloramphenicol Palmitate
Chloramphenicol Sodium Succinate
Chlorhexadol
Chlormadinone Acetate
Chlormerodrin
Chlormethiazole
Chlormethiazole Edisylate
Chlormezanone
Chloroform(3)	(1) 5.0 per cent	(1) Internal
Chloroform(3)		(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
[F21Citalopram Hydrobromide]
Clarithromycin
Clavulanic Acid
Clidinium Bromide
Clindamycin
Clindamycin Hydrochloride
Clindamycin Palmitate Hydrochloride
Clindamycin Phosphate
Clioquinol		(1) External (other than treatment of mouth ulcers)
Clioquinol	(2) 35mg	(2) Treatment of mouth ulcers	(2) 350mg (MDD)
Clobetasol Propionate
Clobetasone Butyrate	[F390.05 per cent]	[F39Cream 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)]		[F39Container 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
Dequalinium Chloride	(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)
Dicyclomine Hydrochloride			60mg (MDD)
[F20Didanosine]
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
[F23Diphenhydramine Hydrochloride	All preparations except liquid-filled capsules]
[F40Diphenoxylate Hydrochloride]	[F402.5 mg]	[F40In combination with Atropine Sulphate for short term use as an adjunctive therapy to appropriate rehydration in acute diarrhoea	[F4025 mg (MDD)]	[F40Container 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
[F40Dolasetron Mesilate]
Domperidone		[F41For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn]	[F4110mg of Domperidone (MD)]	[F41Container or package containing not more than 200mg of Domperidone]
Domperidone			[F4140mg of Domperidone (MDD)]
Domperidone Maleate		[F42For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn,]	[F4310 mg of Domperidone as Domperidone Maleate (MD)]	[F42Container or package containing not more than [F44200mg] of Domperidone as Domperidone Maleate;]
Domperidone Maleate			[F4340 mg of Domperidone as Domperidone Maleate (MDD)]
[F24Donepezil Hydrochloride]
Dopamine Hydrochloride
Dopexamine Hydrochloride
[F21Dorzolamide 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
[F20Eformoterol 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)
		(1) Internal (other than nasal sprays or nasal drops)	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
[F45Estramustine 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
[F21Exemestane]
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 [F4650g] of medicinal product
		[F47For 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		[F39External use (but in the case of vaginal use, only for the treatment of vaginal candidiasis)]
Feprazone
Ferrous Arsenate
[F21Ferumoxsil]
[F24Fexofenadine 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 [F48or 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)
		[F49For use in persons aged 18 years and over]	[F50For a maximum period of 3 months]
		In the form of a non-pressurised nasal spray
		F51...	F51...	F51...
		F51...	F51. . .	F51...
		F51. . .
		F51. . .
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	[F528.75 mg]	[F53Throat lozenges]	[F5443.75 mg (MDD)]	[F55Container or package containing not more than 140 mg of Flurbiprofen]
Flurbiprofen Sodium
Fluspirilene
Flutamide
Fluticasone Propionate
[F24Flutrimazole]
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)
Gelsemium			75mg (MDD)
Gemeprost
Gemfibrozil
Gentamicin
Gentamicin Sulphate
Gestodene
Gestrinone
Gestronol
Gestronol Hexanoate
Glibenclamide
Glibornuride
Gliclazide
Glipizide
Gliquidone
Glisoxepide
Glucagon
Glycopyrronium Bromide			1mg (MD)
Glycopyrronium Bromide			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)
		(1) Internal	0.45mg (MDD)
		(2) External (except ophthalmic)
Homatropine Hydrobromide			0.2mg (MD)
Homatropine Hydrobromide			0.6mg (MDD)
Homatropine Methylbromide			2mg (MD)
Homatropine Methylbromide			6mg (MDD)
Hydralazine Hydrochloride
Hydrargaphen		Local application to skin
Hydrobromic Acid
Hydrochlorothiazide
Hydrocortisone	[F56(1) 0.5 per cent]	[F56(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]		[F56(1) Container or package containing not more than 15g of medicinal product]
Hydrocortisone	[F57(2)] 1.0 per cent	[F57(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 [F58or 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		[F57(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 [F59or 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
[F23Hydrocyanic 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
Hyoscine		(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
		(b) otherwise than by inhaler	80mg (MDD)
		(2) External
Hyoscine Hydrobromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 300mcg (MD)
		(b) otherwise than by inhaler	900mcg (MDD)
		(2) External (except ophthalmic)
Hyoscine Methobromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 2.5mg (MD)
		(b) otherwise than by inhaler	7.5mg (MDD)
		(2) External
Hyoscine Methonitrate		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 2.5mg (MD)
		(b) otherwise than by inhaler	7.5mg (MDD)
		(2) External
Hyoscyamine		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 300mcg (MD)
		(b) otherwise than by inhaler	1mg (MDD)
		(2) External
Hyoscyamine Hydrobromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) Equivalent of 300mcg of Hyoscyamine (MD)
		(b) otherwise than by inhaler	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)
		(b) otherwise than by inhaler	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
	[F60(3) 10.0 per cent]	[F60(3) External]	[F60(3) 125 mg (MD) 500 mg (MDD)]	[F60(3) Container or package containing not more than [F6150g] of medicinal product]
[F23Ibuprofen 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)
[F23Ibuprofen Lysine		Internal	(b) in any other case 400 mg (MD) 1,200 mg (MDD)]
Idarubicin Hydrochloride
Idoxuridine
Ifosfamide
Ignatius Bean
[F20Imidapril Hydrochloride]
Imipenem Hydrochloride
Imipramine
Imipramine Hydrochloride
Imipramine Ion Exchange Resin Bound Salt or Complex
[F35Indapamide]
Indapamide Hemihydrate
Indomethacin
Indomethacin Sodium
Indoprofen
Indoramin Hydrochloride
Inosine Pranobex
[F62Insulin]
Iodamide
Iodamide Meglumine
Iodamide Sodium
Iohexol
Iomeprol
Iopamidol
Iopentol
Iothalamic Acid
Ioversol
Ioxaglic Acid
Ipratropium Bromide
Iprindole Hydrochloride
Iproniazid Phosphate
[F24Irbesartan]
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)
Isopropamide Iodide			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	[F63(a)] [F64External]	[F63(a)] Maximum frequency of application of once every 3 days	[F63(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
		[F65(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
Ketoprofen	2.5 per cent	For rheumatic and muscular pain in adults and children not less than 12	For maximum period of 7 days
Ketorolac Trometamol
Ketotifen Fumarate
Labetalol Hydrocholoride
Lachesine Chloride
Lacidipine
Lamotrigine
Lanatoside C
Lanatoside Complex A, B and C
[F35Lansoprazole]
Latamoxef Disodium
[F35Lercanidipine Hydrochloride]
Levallorphan Tartrate
Levobunolol Hydrochloride
[F23Levocabastine 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
[F66Levocarnitine]		[F66For dietary supplementation]
Levodopa
[F24Levofloxacin]
Levonorgestrel	[F670.75mg]	[F67for 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)
Lithium Carbonate			Equivalent of 15mg of Lithium (MDD)
Lithium Citrate
Lithium Succinate
Lithium Sulphate			Equivalent of 5mg of Lithium (MD)
Lithium Sulphate			Equivalent of 15mg of Lithium (MDD)
Lobeline		(1) Internal	(1) 3mg (MD)
		(1) Internal	9mg (MDD)
		(2) External
Lobeline Hydrochloride		(1) Internal	(1) Equivalent of 3mg of Lobeline (MD)
		(1) Internal	Equivalent of 9mg of Lobeline (MDD)
		(2) External
Lobeline Sulphate		(1) Internal	(1) Equivalent of 3mg of Lobeline (MD)
		(1) Internal	Equivalent of 9mg of Lobeline (MDD)
		(2) External
Lodoxamide Trometamol	[F68equivalent of 0.1 per cent Lodoxamide]	[F69For 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)	F70. . .
[F36Lornoxicam]
[F36Losartan 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		[F71(a) For the symptomatic relief of irritable bowel syndrome	[F71(a) 135 mg (MD) 405 mg (MDD)]
Mebeverine Hydrochloride		(b) For uses other than the symptomatic relief of irritable bowel syndrome]	[F71(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
[F35Meloxicam]
Melphalan
Melphalan Hydrochloride
Menotrophin
Mepenzolate Bromide			25mg (MD)
Mepenzolate Bromide			75mg (MDD)
Mephenesin
Mephenesin Carbamate
Mepivacaine Hydrochloride		Any use except ophthalmic use
Meptazinol Hydrochloride
Mequitazine
[F24Mercaptamine 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)
Methylephedrine Hydrochloride			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	[F72(1) 2.0 per cent]	[F72(1) External
Minoxidil	[F72(2) 5.0 per cent	(2) External use for the treatment of alopecia androgenetica, in men aged 18 to 65 (but not in women);]
[F20Mirtazapine]
Misoprostol
Mitobronitol
Mitomycin
Mitozantrone Hydrochloride
Mivacurium Chloride
[F45Mizolastine]
Moclobemide
[F24Modafinil]
[F21Moexipril Hydrochloride]
Molgramostim
Molindone Hydrochloride
Mometasone Furoate
Moracizine Hydrochloride
Morazone Hydrochloride
[F20Moxonidine]
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
Naphazoline Hydrochloride	(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
[F24Naratriptan Hydrochloride]
Natamycin
[F36Nebivolol Hydrochloride]
Nedocromil Sodium	[F732.0 per cent]	[F73For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis]		[F73Container 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
[F45Niceritrol]
Nicotinic Acid		Any use, except for the treatment of hyperlipidaemia	600mg (MDD)
Nicoumalone
Nifedipine
Nifenazone
Nikethamide
[F23Nilutamide]
Nimodipine
Niridazole
[F36Nisoldipine]
Nitrendipine
Nitrofurantoin
Nitrofurazone
Nizatidine		For the prevention [F74and treatment] of the symptoms of food-related heartburn [F74and meal-induced indigestion]	75mg (MD)
			[F75150mg (MDD)]
			[F76For 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	[F773.0 per cent]	[F77External		[F77Container 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
[F20Omeprazole 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
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)
Oxyphenonium Bromide			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
Pancreatin	(2) 25,000 European Pharmacopoeia units of lipase per gram	(2) powder
Pancuronium Bromide
[F35Pantoprazole Sodium]
Papaverine		(1) By inhaler
		(2) Otherwise than by inhaler	(2) 50mg (MD)
		(2) Otherwise than by inhaler	150mg (MDD)
Papaverine Hydrochloride		(1) By inhaler
		(2) Otherwise than by inhaler	(2) Equivalent of 50mg of Papaverine (MD)
		(2) Otherwise than by inhaler	Equivalent of 150mg of Papaverine (MDD)
[F25Paracetamol	(1) [F78250mg]	(1) Non-effervescent tablets and capsules [F79wholly or mainly] for use in children aged less than 12 years		(1) The quantity sold or supplied in one container or package shall not exceed 32 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100
	(2) 500 mg	(2) Non-effervescent tablets and capsules [F80wholly or mainly] for use in adults and children not less than 12 years
	(2) 500 mg	(3) All preparations other than non-effervescent tablets and capsules		(2) The quantity sold or supplied in one container or package shall not exceed 32 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100]
Paraldehyde
Paramethadione
Paramethasone Acetate
Parathyroid Gland
Pargyline Hydrochloride
Paroxetine Hydrochloride
Pecilocin
Penamecillin
Penbutolol Sulphate
[F35Penciclovir]
Penicillamine
Penicillamine Hydrochloride
Pentamidine Isethionate
Penthienate Bromide			5mg (MD)
Penthienate Bromide			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
[F81Phenolphthalein.]
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)
		(2) prolonged release capsules	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
[F23Phytomenadione		Any use except the prevention or treatment of haemorrhagic disorders]
Picrotoxin
Pilocarpine
Pilocarpine Hydrochloride
Pilocarpine Nitrate
Pimozide
Pindolol
Pipenzolate Bromide			5mg (MD)
Pipenzolate Bromide			15mg (MDD)
Piperacillin Sodium
Piperazine Oestrone Sulphate
Piperidolate Hydrochloride			50mg (MD)
Piperidolate Hydrochloride			150mg (MDD)
Pipothiazine Palmitate
Piracetam
Pirbuterol Acetate
Pirbuterol Hydrochloride
[F82Pirenzepine 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
[F45Piroxicam 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
Podophyllum Resin	20.0 per cent	Ointment or impregnated plaster
Poldine Methylsulphate			2mg (MD)
Poldine Methylsulphate			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
[F24Pramipexole 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	[F393mg]	[F39Buccal tablets for the treatment of nausea and vomiting in cases of previously diagnosed migraine only. For use in persons aged 18 years and over.]	[F3912mg (MDD)]	[F39Container 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)
Propantheline Bromide			45mg (MDD)
[F36Propiverine 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)
Pseudoephedrine Sulphate			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
[F36Quetiapine Fumarate]
[F21Quinagolide Hydrochloride]
Quinapril
[F82Quinapril Hydrochloride]
Quinestradol
Quinestrol
Quinethazone
Quinidine
Quinidine Bisulphate
Quinidine Polygalacturonate
Quinidine Sulphate
Quinine			100mg (MD)
Quinine			300mg (MDD)
Quinine Bisulphate			Equivalent of 100mg of Quinine (MD)
Quinine Bisulphate			Equivalent of 300mg of Quinine (MDD)
Quinine Cinchophen			Equivalent of 100mg of Quinine (MD)
Quinine Cinchophen			Equivalent of 300mg of Quinine (MDD)
Quinine Dihydrochloride			Equivalent of 100mg of Quinine (MD)
Quinine Dihydrochloride			Equivalent of 300mg of Quinine (MDD)
Quinine Ethyl Carbonate			Equivalent of 100mg of Quinine (MD)
Quinine Ethyl Carbonate			Equivalent of 300mg of Quinine (MDD)
Quinine Glycerophosphate			Equivalent of 100mg of Quinine (MD)
Quinine Glycerophosphate			Equivalent of 300mg of Quinine (MDD)
Quinine Hydrobromide			Equivalent of 100mg of Quinine (MD)
Quinine Hydrobromide			Equivalent of 300mg of Quinine (MDD)
Quinine Hydrochloride			Equivalent of 100mg of Quinine (MD)
Quinine Hydrochloride			Equivalent of 300mg of Quinine (MDD)
Quinine Iodobismuthate			Equivalent of 100mg of Quinine (MD)
Quinine Iodobismuthate			Equivalent of 300mg of Quinine (MDD)
Quinine Phosphate			Equivalent of 100mg of Quinine (MD)
Quinine Phosphate			Equivalent of 300mg of Quinine (MDD)
Quinine Salicylate			Equivalent of 100mg of Quinine (MD)
Quinine Salicylate			Equivalent of 300mg of Quinine (MDD)
Quinine Sulphate			Equivalent of 100mg of Quinine (MD)
Quinine Sulphate			Equivalent of 300mg of Quinine (MDD)
Quinine Tannate			Equivalent of 100mg of Quinine (MD)
Quinine Tannate			Equivalent of 300mg of Quinine (MDD)
Quinine in combination with Urea Hydrochloride
Ramipril
[F20Ranitidine Bismuth Citrate]
Ranitidine Hydrochloride		For the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity [F83or 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
[F24Reboxetine Mesilate]
Remoxipride Hydrochloride
Reproterol Hydrochloride
Rescinnamine
Reserpine
Rifabutin
Rifampicin
Rifampicin Sodium
Rifamycin
[F20Rimexolone]
Rimiterol Hydrobromide
Risperidone
Ritodrine Hydrochloride
Rolitetracycline Nitrate
[F40Ropinirole Hydrochloride]
Sabadilla
Salbutamol
Salbutamol Sulphate
Salcatonin
Salcatonin Acetate
Salmefamol
Salmeterol Xinafoate
Salsalate
Saralasin Acetate
Selegiline Hydrochloride
Semisodium Valproate
[F24Sertindole]
[F20Sertraline Hydrochloride]
Serum Gonadotrophin
[F20Sevoflurane]
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 [F84or perennial allergic conjunctivitis]		(b) Container or package containing not more than 10ml of medicinal product
	(b) 2.0 per cent	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
	(c) 4.0 per cent	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
[F21Sparfloxacin]
Spectinomycin
Spectinomycin Hydrochloride
Spiramycin
Spiramycin Adipate
Spironolactone
Stannous Fluoride	([F851]) 0.62 per cent	([F851]) Dentifrice
Stannous Fluoride	[F85(2) 0.4 per]	[F85(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
[F23Strychnine Nitrate]
Styramate
Succinylsulphathiazole
Sucralfate
Sulbactam Sodium
Sulbenicillin
Sulbenicillin Sodium
Sulconazole Nitrate		External (except vaginal)
[F23Sulfabenzamide]
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
[F36Tacalcitol Monohydrate]
Tacrine Hydrochloride
Talampicillin
Talampicillin Hydrochloride
Talampicillin Napsylate
Tamoxifen
Tamoxifen Citrate
[F35Tamsulosin Hydrochloride]
[F20Tazarotene]
Tazobactam Sodium
Teicoplanin
[F24Temocapril Hydrochloride]
Temocillin Sodium
Tenoxicam
Terazosin Hydrochloride
Terbinafine	[F861.0 per cent]	[F87External use for the treatment of tinea pedis, tinea cruris and tinea corporis. In the form of a gel]		[F88Container or package containing not more than 30 grams of medicinal product]
[F89Terbinafine Hydrochloride]	[F891.0 per cent]	([F901]) [F91Preparations, other than spray solutions, for] [F89external use for the treatment of tinea pedis and tinea cruris]		([F901]) [F89Container or package containing not more than 15 g of medicinal product.]
[F89Terbinafine Hydrochloride]	[F891.0 per cent]	[F92(2) Spray solutions for external use for the treatment of tinea corporis, tinea cruris and tinea pedis]		[F92(2) Container containing not more than 30ml of medicinal product]
Terbutaline
Terbutaline Sulphate
Terfenadine			F93. . .	F93...
Terlipressin
Terodiline Hydrochloride
[F24Testosterone]
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
[F35Ticlopidine Hydrochloride]
Tigloidine Hydrobromide
[F35Tiludronate Disodium]
Timolol Maleate
Tinidazole
Tinzaparin
Tioconazole	(1) 2.0 per cent	(1) External (except vaginal)
Tioconazole	(1) 2.0 per cent	(2) Vaginal for treatment of vaginal candidiasis
[F21Tizanidine Hydrochloride]
Tobramycin
Tobramycin Sulphate
Tocainide Hydrochloride
Tofenacin Hydrochloride
Tolazamide
Tolazoline Hydrochloride		External
Tolbutamide
Tolbutamide Sodium
Tolfenamic Acid
Tolmetin Sodium
[F20Topiramate]
[F45Torasemide]
[F35Toremifene]
Tramadol Hydrochloride
Trandolapril
Tranexamic Acid
Tranylcypromine Sulphate
Trazodone Hydrochloride
Treosulfan
Tretinoin
Triamcinolone
Triamcinolone Acetonide	[F94(1)] 0.1 per cent	[F94(1)] For the treatment of common mouth ulcers		[F94(1)] Container or package containing not more than 5g of medicinal product
		[F95(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]	[F95(2) 110mcg per nostril (MD)	[F95Container 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)
[F21Valaciclovir Hydrochloride]
Valproic Acid
[F24Valsartan]
Vancomycin Hydrochloride
Vasopressin
Vasopressin Tannate
Vecuronium Bromide
[F21Venlafaxine 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)
Vitamin A		(2) External
Vitamin A Acetate		(1) Internal	(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)
Vitamin A Acetate		(2) External
Vitamin A Palmitate		(1) Internal	(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)
Vitamin A Palmitate		(2) External
Warfarin
Warfarin Sodium
Xamoterol Fumarate
Xipamide
Yohimbine Hydrochloride
[F21Zalcitabine]
Zidovudine
Zimeldine Hydrochloride
Zolpidem Tartrate
Zomepirac Sodium
Zopiclone
Zuclopenthixol Acetate
Zuclopenthixol Decanoate
Zuclopenthixol Hydrochloride]

Textual Amendments

F20Words 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)

F21Words 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)

F22Words 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)

F23Words 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.

F24Sch. 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)

F25Words 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

F26Words 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)

F27Words 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)

F28Sch. 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)

F29Words 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)

F30Words 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)

F31Words 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)

F32Word 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)

F33Words 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)

F34Words 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)

F35Words 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)

F36Words 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)

F37Word 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)

F38Words 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)

F39Sch. 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)

F40Sch. 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)

F41Sch. 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)

F42Words 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)

F43Words 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)

F44Words 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)

F45Words 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)

F46Word 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)

F47Words 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)

F48Words 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)

F49Words 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)

F50Words 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)

F51Words 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)

F52Words 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)

F53Words 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)

F54Words 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)

F55Words 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)

F56Words 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)

F57Sch. 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)

F58Words 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)

F59Words 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)

F60Words 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)

F61Words 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)

F62Word 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)

F63Word 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)

F64Words 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)

F65Words 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)

F66Words 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)

F67Sch. 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

F68Words 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)

F69Words 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)

F70Words 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)

F71Words 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)

F72Words 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)

F73Words 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)

F74Words 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)

F75Words 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)

F76Words 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)

F77Words 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)

F78Words 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)

F79Words 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)

F80Words 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)

F81Words 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)

F82Words 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)

F83Words 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)

F84Words 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)

F85Sch. 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)

F86Words 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)

F87Words 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)

F88Words 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)

F89Words 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)

F90Sch. 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)

F91Words 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)

F92Sch. 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)

F93Words 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)

F94Sch. 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)

F95Sch. 1 entries inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 4(g)

Article 10(1)

[F96SCHEDULE 2SUBSTANCES WHICH MAY BE EXCLUDED FROM THE CLASS OF PRESCRIPTION ONLY MEDICINES AT HIGH DILUTION

Textual Amendments

F96Sch. 2 substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 12

Codeine and its salts
Dihydrocodeine and its salts
Ethylmorphine and its salts
Morphine and its salts
Medicinal Opium
Pholcodine and its salts]

Article 2(b)

F97SCHEDULE 3DESCRIPTIONS AND CLASSES OF PRESCRIPTION ONLY MEDICINES IN RELATION TO WHICH community practitioner nurse prescribers ARE APPROPRIATE PRACTITIONERS

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

Textual Amendments

F97Schs. 3-7 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Article 3A

F97SCHEDULE 3ACONTROLLED DRUGS WHICH MAY BE PRESCRIBED, ADMINISTERED OR DIRECTED FOR ADMINISTRATION BY NURSE INDEPENDENT PRESCRIBERS AND CONDITIONS FOR SUCH PRESCRIPTION OR ADMINISTRATION

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

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

F97SCHEDULE 3BPARTICULARS FOR CLINICAL MANAGEMENT PLANS

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

Article 8(4)(c)

F97SCHEDULE 4SUBSTANCES NOT TO BE CONTAINED IN A PRESCRIPTION ONLY MEDICINE SOLD OR SUPPLIED UNDER THE EXEMPTION CONFERRED BY ARTICLE 8(3)

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

Article 11(1)(a)

F97SCHEDULE 5EXEMPTION FOR CERTAIN PERSONS FROM SECTION 58(2) OF THE ACT

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

Article 16(1)

F97SCHEDULE 6ORDERS REVOKED

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

Articles 12A to 12C

F97SCHEDULE 7

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Explanatory Note

(This note is not part of the Order)

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

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

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

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

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

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

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

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

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

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

(1)

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

(2)

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

(3)

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

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The Prescription Only Medicines (Human Use) Order 1997

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1997 No. 1830

The Prescription Only Medicines (Human Use) Order 1997

Citation, commencement and interpretation

Appropriate practitioners

Medicinal products on prescription only

Prescribing and administration by nurse independent prescribers

Prescribing and administration by supplementary prescribers

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

Duration of special provisions in relation to new medicinal products

Exempt medicinal products

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

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

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

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

Exemptions for administration of smallpox vaccine

Exemption for administration by operators

Exemptions for emergency sale or supply

Exemption for non-parenteral administration to human beings

Exemption for medicinal products at high dilutions

Exemptions for certain persons

Exemption for sale or supply in hospitals

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

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

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

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

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

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

Exemption in cases involving another’s default

Exemptions relating to prescriptions given by certain health professionals

Exemption in the case of a forged prescription

Prescriptions

Revocations

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

[F96SCHEDULE 2SUBSTANCES WHICH MAY BE EXCLUDED FROM THE CLASS OF PRESCRIPTION ONLY MEDICINES AT HIGH DILUTION

F97SCHEDULE 3DESCRIPTIONS AND CLASSES OF PRESCRIPTION ONLY MEDICINES IN RELATION TO WHICH community practitioner nurse prescribers ARE APPROPRIATE PRACTITIONERS

F97SCHEDULE 3ACONTROLLED DRUGS WHICH MAY BE PRESCRIBED, ADMINISTERED OR DIRECTED FOR ADMINISTRATION BY NURSE INDEPENDENT PRESCRIBERS AND CONDITIONS FOR SUCH PRESCRIPTION OR ADMINISTRATION

F97SCHEDULE 3BPARTICULARS FOR CLINICAL MANAGEMENT PLANS

F97SCHEDULE 4SUBSTANCES NOT TO BE CONTAINED IN A PRESCRIPTION ONLY MEDICINE SOLD OR SUPPLIED UNDER THE EXEMPTION CONFERRED BY ARTICLE 8(3)

F97SCHEDULE 5EXEMPTION FOR CERTAIN PERSONS FROM SECTION 58(2) OF THE ACT

F97SCHEDULE 6ORDERS REVOKED

F97SCHEDULE 7

Explanatory Note

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