The Prescription Only Medicines (Human Use) Order 1997

Citation, commencement and interpretation

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

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

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“inhaler” does not include an aerosol;

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“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;

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[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 [F9 Schedules 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

F1 Words 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)

F2 Words in art. 1 omitted (1.4.2002) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(a)

F3 Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(b)

F4 Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(c)

F5 Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(d)

F6 Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(e)

F7 Words in art. 1 omitted (9.7.2003) by virtue of The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(2)(b)

F8 Art. 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)

F9 Words 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)

F10 Art. 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

F11 2.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11 Arts. 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

F11 3.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11 Arts. 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

F11 3A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11 Arts. 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

F11 3B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11 Arts. 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

F11 3C.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11 Arts. 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

F11 4.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11 Arts. 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)  [F12 A 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.

[F13 (1A) In paragraph (1) “marketing authorisation” means—

(a) in relation to medicinal products for sale or supply in Great Britain, a UKMA(GB) or UKMA(UK);

(b) in relation to medicinal products for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK), an EU marketing authorisation or a parallel import licence.]

(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 [F14 ,

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

F12 Words 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)

F13 Art. 5(1A) inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 4 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 194(a)); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in art. 5(4) added (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 2

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

F15 5A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F15 Arts. 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

F15 5B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F15 Arts. 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

F15 6.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F15 Arts. 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

F15 7.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F15 Arts. 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

F15 7A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F15 Arts. 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

F11 7B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11 Arts. 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

F15 8.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F15 Arts. 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

F15 9.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F15 Arts. 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.— [F16 (1)] [F17 A 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 [F18 or in Schedule 2], only one or more unit preparation of such substances, if–

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

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

[F19 (2) [F17 A 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

F16 Art. 10 renumbered as art. 10(1) (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 9

F17 Words 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)

F18 Words in art. 10(1) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 8

F19 Art. 10(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 9

Exemptions for certain persons

F20 11.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 12.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 12A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 12B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 12C.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 12D.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 12E.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 12F.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 13.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 13A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 14.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 15.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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

F20 16.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Arts. 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