Citation, commencement and interpretation1

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–

F152A

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 F16Schedules 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.

F176

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F177

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F178

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F179

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Appropriate practitionersF112

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Medicinal products on prescription onlyF113

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Prescribing and administration by nurse independent prescribersF113A

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Prescribing and administration by supplementary prescribersF113B

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Exemptions from conditions in respect of the cases or circumstances in which a supplementary prescriber may administer a medicinal productF113C

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Duration of special provisions in relation to new medicinal productsF114

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Exempt medicinal products5

1

F18A 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.

F201A

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 F1,

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.

Exemption for products consisting of or containing aloxiprin, aspirin or paracetamolF125A

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Exemption for products consisting of or containing pseudoephedrine salts or ephedrine base or saltsF125B

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Circumstances in which controlled drugs and medicinal products authorized by the European Community are not prescription only medicinesF126

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Exemption for parenteral administration in an emergency to human beings of certain prescription only medicinesF127

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Exemptions for administration of smallpox vaccineF127A

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Exemption for administration by operatorsF117B

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Exemptions for emergency sale or supplyF128

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Exemption for non-parenteral administration to human beingsF129

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Exemption for medicinal products at high dilutions10

F41

F19A 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 F10or 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).

F32

F19A 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)

Exemptions for certain personsF1311

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Exemption for sale or supply in hospitalsF1312

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Exemptions for the supply and administration of prescription only medicines by national health service bodiesF1312A

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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 servicesF1312B

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Exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group DirectionF1312C

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Exemption for the supply and administration of prescription only medicines by independent hospitals, clinics and agenciesF1312D

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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 forcesF1312E

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Exemption for the supply of prescription only medicines in the event or anticipation of pandemic diseaseF1312F

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Exemption in cases involving another’s defaultF1313

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Exemptions relating to prescriptions given by certain health professionals F1313A

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Exemption in the case of a forged prescriptionF1314

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PrescriptionsF1315

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RevocationsF1316

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Signed by authority of the Secretary of State for Health

Baroness JayMinister of State,Department of Health
Win GriffithsParliamentary Under Secretary of State, Welsh Office
Sam GalbraithParliamentary Under Secretary of State, The Scottish Office
Jeff RookerMinister 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.

seal_r00001D. C. GowdyPermanent Secretary

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

seal_r00001P. SmallPermanent Secretary