Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984
| Jurisdiction | UK Non-devolved |
| Citation | SI 1984/769 |
| Year | 1984 |
1984 No. 769
MEDICINES
The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 19844thJune 1984
30thJune 1984
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, 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 by sections 51 and 129(4) of the Medicines Act 1968(a) and now vested in them (b) 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 section 129(7) of that Act, hereby make the following order:—
Citation, commencement and interpretation
1.— (1) This order, which may be cited as the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984, shall come into operation on 30th June 1984.
(2) In this order, unless the context otherwise requires—
(a) "the Act" means the Medicines Act 1968;
"cosmetic" means any substance or preparation intended to be applied to the various surfaces of the human body including epidermis, pilary system and hair, nails, lips and external genital organs, or the teeth and buccal mucosa, wholly or mainly for the purpose of perfuming them, cleansing them, protecting them, caring for them or keeping them in condition, modifying their appearance (whether for aesthetic purposes or otherwise) or combating body odours or normal body perspiration;
(a) 1968 c. 67.
(b) 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).
"dosage unit" means:
(i) where a medicinal product is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article, and
(ii) where a medicinal product is not in any such form, that quantity of the product which is used as the unit by reference to which the dose is measured;
"excipient" means a substance which does not contribute to the pharmacological action of the medicinal product, or which so contributes only by regulating the release of the active ingredients;
"external use" means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal when a local action only is intended and extensive systemic absorption is unlikely to occur; and references to medicinal products for external use shall be read accordingly except that such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;
"food" includes beverages, confectionery and articles and substances used as ingredients in the preparation of food and includes any manufactured substance to which there has been added any vitamin and which is advertised (within the meaning of section 92 of the Act) as available and for sale to the general public as a dietary supplement;
"maximum daily dose" or "MDD" means the maximum quantity of the substance contained in the amount of a medicinal product for internal use which it is recommended should be taken or administered in any period of twenty-four hours;
"maximum dose" or "MD" means the maximum quantity of the substance contained in the amount of a medicinal product for internal use which it is recommended should be taken or administered at any one time;
"maximum strength" means either the maximum quantity of the substance by weight or volume contained in a dosage unit of a medicinal product or the maximum percentage of the substance contained in a medicinal product calculated in terms of weight in weight, weight in volume, volume in weight or volume in volume as appropriate;
"medicinal product" has the same meaning as in the Act except that it does not include a medicinal product which is a veterinary drug as defined in section 132(1) of the Act;
"parenteral administration" means administration by breach of the skin or mucous membrane;
"prescription only medicine" means a medicinal product of a description or falling within a class specified in Article 3 of the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983(a);
"product licence of right" means a product licence, whether or not for the time being in force, to which a person was entitled by virtue of section 25 of the Act and a reference to a "product the subject of a
(a) S.I. 1983/1212.
product licence of right" is a reference to a medicinal product in respect of which there is, or was, in force at the time of its manufacture a product licence of right; and
(b) a reference to a numbered Schedule is to the Schedule to this order which bears that number, a reference in an Article or Schedule to a numbered paragraph is to the paragraph of that Article or Schedule which bears that number and a reference in a Schedule to a Table is to the appropriate Table in that Schedule.
(3) In Schedules 1 and 2—
(a) the following abbreviations are used:
"g" for gram,
"iu" for international unit of activity,
"mcg" for microgram,
"mg" for milligram, and
"ml" for millilitre; and
(b) entries in columns 2, 3 and 4 in the Tables 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 column 2, 3 or 4 bears a number or letter it relates only to such entries in the other of those columns as bear the same number or letter.
General sale list
2. There are hereby specified classes of medicinal products which in the opinion of the Ministers can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist, namely, medicinal products which are not prescription only medicines but which are—
(a) medicinal products, other than products the subject of a product licence of right, which fall within the class specified in Schedule 1 but which do not fall within a class specified in Schedule 3;
(b) medicinal products which are products the subject of a product licence of right and which fall within the class specified in Schedule 2 but which do not fall within a class specified in Schedule 3; and
(c) medicinal products which are for sale or supply either for oral administration as a food or for external use as a cosmetic, other than products which are eye drops or eye ointments or which contain either—
(i) Vitamin A, Vitamin A acetate or Vitamin A palmitate with a maximum daily dose equivalent to more than 7500 international units of Vitamin A or 2250 micrograms of retinol, or
(ii) Vitamin D with a maximum daily dose of more than 400 units of antirachitic activity.
Automatic machines section of the general sale list
3. The classes of medicinal products specified in Article 2 of this order are hereby designated as being products which in the opinion of the Ministers can with reasonable safety be sold by means of automatic machines.
Revocations
4. The Medicines (General Sale List) Order 1980(a) and the Medicines (General Sale List) Amendment Order 1982(b) are hereby revoked.
Signed by authority of the Secretary of State for Social Services.
K. Clarke, Minister of State, Department of Health and Social Security.
22nd May 1984.
Nicholas Edwards, Secretary of State for Wales.
14th May 1984.
George Younger, Secretary of State for Scotland.
8th May 1984.
In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 11th May 1984.
Michael Jopling, Minister of Agriculture, Fisheries and Food.
(L.S.)
(a) S.I. 1980/1922.
(b) S.I. 1982/26.
Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 25th day of May 1984.
Maurice N. Hayes, Permanent Secretary.
(L.S.)
Sealed with the official seal of the Department of Agriculture for Northern Ireland this 4th day of June 1984.
W. H. Jack, Permanent Secretary.
(L.S.)
Article 2(a)
SCHEDULE 1
CLASS OF MEDICINAL PRODUCTS (OTHER THAN PRODUCTS THE SUBJECT OF A PRODUCT LICENCE OF RIGHT) ON GENERAL SALE BY VIRTUE OF ARTICLE 2(a)
1. Subject to paragraphs 2 and 3, the class of medicinal products which are composed solely of one or more of the following substances, namely—
(1) a substance listed in column 1 of Table A where the maximum strength of the substance in the medicinal product does not exceed the maximum strength, if any, specified in column 2 of Table A;
(2) if the product is for external use only, a substance listed in column 1 of Table B where the maximum strength of the substance in the medicinal product does not exceed the maximum strength, if any, specified in column 2 of Table B;
(3) an aqueous or alcoholic extract, spirit, syrup or liquid suspension derived from a substance listed in column 1 of Table A or, if the product is for external use only, Table B;
(4) an excipient.
2. Where a medicinal product of the class specified in paragraph 1 has as an ingredient a substance listed in column 1 of Table A or Table B and there is in relation to that substance an entry in column 3, such product only if—
(1) where a use is specified in column 3, the product is in a...
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