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Medicinal products on prescription only
     3. Subject to article 6, the following descriptions and classes of medicinal products are specified for the purposes of section 58, namely-

(a) medicinal products consisting of or containing a substance listed in column 1 of Schedule 1;

(b) medicinal products that are controlled drugs;

(c) medicinal products that are for parenteral administration, other than preparations of insulin for parenteral administration;

(d) cyanogenetic substances, other than preparations for external use;

(e) medicinal products that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used;

(f) medicinal products for human use which are classified as subject to medical prescription in marketing authorizations granted under Council Regulation 2309/93[1];

(g) medicinal products-


(i) which are not of a description and do not fall within a class specified in subparagraphs (a) to (f),

(ii) which are of a description in respect of which the conditions specified in section 59(1) are satisfied, and

(iii) in respect of which a product licence or marketing authorization has been granted which contains a provision to the effect that the method of sale or supply of the medicinal product is to be only in accordance with a prescription given by an appropriate practitioner.

Duration of special provisions in relation to new medicinal products
     4. The duration specified for the purposes of section 59(2)(a) (duration of restrictions for certain new products) shall be a period of 5 years.

Exempt medicinal products
     5.  - (1) A medicinal product shall be exempt from the restrictions imposed by section 58(2)(a) (restrictions on sale or supply) if it, or a substance in it, is listed in column 1 of Schedule 1 and there-

(a) is an entry in column 2, 3, 4 or 5 of that Schedule which contains a condition and that condition is satisfied in accordance with the following provisions of this article; or

(b) there is more than one such condition which applies where that substance is used in that product and each of those conditions is so satisfied.

    (2) Where a maximum strength is specified in column 2 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where the maximum strength of that substance in that medicinal product, or where specified in that column the maximum strength of a medicinal product which contains that substance, does not exceed that specified maximum or, where the medicinal product consists of more than one of the substances sodium fluoride, sodium monofluorophosphate or stannous fluoride combined in a dentifrice, where the maximum strength of that combination of substances in a product does not exceed the equivalent of 0.15 per cent of fluorine.

    (3) Where a route of administration is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for administration only by that route.

    (4) Where a use is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition in respect of use where it is sold or supplied only for use-

(a) where a purpose for which it may be used is so specified, for that purpose;

(b) where the class of persons in whom it may be used is so specified, in persons of that class.

    (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.

Circumstances in which controlled drugs and medicinal products authorized by the European Community are not prescription only medicines
     6.  - (1) A medicinal product shall not be a prescription only medicine by reason that it is a controlled drug listed in Schedule 2 to the Misuse of Drugs Act 1971 where, it-

(a) contains not more than one of the substances listed in column 1 of Schedule 2 to this Order and no other controlled drug;

(b) contains that substance at a strength that does not exceed the maximum strength specified in column 2 of that Schedule; and

(c) is sold or supplied-


(i) in such pharmaceutical form as may be specified in column 3 of that Schedule, and

(ii) for use at a maximum dose which does not exceed that specified in column 4 of that Schedule.

    (2) A medicinal product for human use in respect of which a marketing authorization has been granted under Council Regulation 2309/93/EEC[2] shall not be a prescription only medicine where that authorization does not classify the medicinal product as subject to medical prescription.

Exemption for parenteral administration in an emergency to human beings of certain prescription only medicines
     7. The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration to human beings of any of the following medicinal products for parenteral administration-

Adrenaline Injection 1 in 1000 (1 mg in 1 ml)

Atropine Sulphate Injection

Chlorpheniramine Injection

Cobalt Edetate Injection

Dextrose Injection Strong B.P.C.

Diphenhydramine Injection

Glucagon Injection

Hydrocortisone Injection

Mepyramine Injection

Promethazine Hydrochloride Injection

Snake Venom Antiserum

Sodium Nitrite Injection

Sodium Thiosulphate Injection

Sterile Pralidoxime

where the administration is for the purpose of saving life in an emergency.

Exemptions for emergency sale or supply
     8.  - (1) The restrictions imposed by section 58(2)(a) (restriction on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions specified in paragraph (2) are satisfied.

    (2) The conditions referred to in paragraph (1) are-

(a) that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied is satisfied that the sale or supply has been requested by a doctor who by reason of an emergency is unable to furnish a prescription immediately;

(b) that the doctor has undertaken to furnish the person lawfully conducting a retail pharmacy business with a prescription within 72 hours of the sale or supply;

(c) that the prescription only medicine is sold or supplied in accordance with the directions of the doctor requesting it;

(d) subject to paragraph (5), that the prescription only medicine is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations;

(e) that an entry is made in the record kept under regulation 6 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980[3] within the time specified in that regulation stating the particulars required under paragraph 1 of Schedule 2 to those Regulations.

    (3) The restrictions imposed by section 58(2)(a) shall not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions specified in paragraph (4) are satisfied.

    (4) The conditions referred to in paragraph (3) are-

(a) that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied has interviewed the person requesting a prescription only medicine and has satisfied himself-


(i) that there is an immediate need for the prescription only medicine requested to be sold or supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay,

(ii) that treatment with the prescription only medicine requested has on a previous occasion been prescribed by a doctor for the person requesting it, and

(iii) as to the dose which in the circumstances it would be appropriate for that person to take;



(b) that no greater quantity of the prescription only medicine than will provide 5 days' treatment is sold or supplied except that where the prescription only medicine-



(i) is an aerosol for the relief of asthma, an ointment or cream, and has been made up for sale in a container elsewhere than at the place of sale or supply, the smallest pack that the pharmacist has available for sale or supply may be sold or supplied,

(ii) is an oral contraceptive, a quantity sufficient for a full treatment cycle may be sold or supplied,

(iii) is an antibiotic for oral administration in liquid form, the smallest quantity that will provide a full course of treatment may be sold or supplied;



(c) subject to paragraph (5), that the prescription only medicine does not consist of or contain a substance specified in Schedule 4 to this Order and is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations;

(d) that an entry is made in the record kept under regulation 6 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 within the time specified in that regulation stating the particulars required under paragraph 3 of Schedule 2 to those Regulations;

(e) that the container or package of the prescription only medicine is labelled so as to show-



(i) the date on which the prescription only medicine is sold or supplied,

(ii) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine,

(iii) the name of the person requesting the prescription only medicine,

(iv) the name and address of the registered pharmacy from which the prescription only medicine is sold or supplied, and

(v) the words "Emergency Supply".

    (5) The conditions specified in paragraphs (2)(d) and (4)(c) shall not apply where the prescription only medicine consists of or contains phenobarbitone or phenobarbitone sodium (but no other substance specified in Schedule 4 to this Order or Schedule 1, 2 or 3 to the Misuse of Drugs Regulations) and is sold or supplied for use in the treatment of epilepsy.

[2] OJ No. L214, 24.8.93, p. 1.back

[3] S.I. 1980/1923, amended by S.I. 1997/1831.back