(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–
the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;
the maximum percentage of a substance contained in a medicinal product calculated in any of the following ways–
weight in weight,
weight in volume,
volume in weight, or
volume in volume,
and if the maximum percentage calculated in those ways differs, the higher or highest such percentage;
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(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 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.
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S.I. 1997/1830
The Prescription Only Medicines (Human Use) Order 1997
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.
Data synced
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reg 3CExemptions from conditions in respect of the cases or circumstances in which a supplementary prescriber may administer a medicinal productOpen ↗
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(1) 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.
(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 ,
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.
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reg 5BExemption for products consisting of or containing pseudoephedrine salts or ephedrine base or saltsOpen ↗
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reg 6Circumstances in which controlled drugs and medicinal products authorized by the European Community are not prescription only medicinesOpen ↗
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reg 7Exemption for parenteral administration in an emergency to human beings of certain prescription only medicinesOpen ↗
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(1) 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 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).
(2) 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)
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reg 12AExemptions for the supply and administration of prescription only medicines by national health service bodiesOpen ↗
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reg 12BExemption 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 servicesOpen ↗
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reg 12CExemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group DirectionOpen ↗
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reg 12DExemption for the supply and administration of prescription only medicines by independent hospitals, clinics and agenciesOpen ↗
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reg 12EExemption 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 forcesOpen ↗
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reg 12FExemption for the supply of prescription only medicines in the event or anticipation of pandemic diseaseOpen ↗
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Cite this legislation
- Official citation
- S.I. 1997/1830
- Source
- legislation.gov.uk
- Data synced
- Licence
- OGL-3 ↗
The Prescription Only Medicines (Human Use) Order 1997 (legislation.gov.uk, OGL-3). Retrieved via LawPlayer, https://lawplayer.com/uk/act/uksi-1997-1830
This text is synced from legislation.gov.uk. In case of any discrepancy, the official version prevails.
Contains public sector information licensed under the Open Government Licence v3.0 (legislation.gov.uk).