Medicines (General Sale List) Order 1980
| Jurisdiction | UK Non-devolved |
| Citation | SI 1980/1922 |
| Year | 1980 |
1980 No. 1922
MEDICINES
The Medicines (General Sale List) Order 19808thDecember 1980
30thJanuary 1981
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 the following order, and after taking into account the advice of the Medicines Commission, hereby make the following order:—
Citation, commencement and interpretation
1.—(1) This order, which may be cited as the Medicines (General Sale List) Order 1980, shall come into operation on 30th January 1981.
(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;
"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;
(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).
"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:
(i) in relation to medicinal products for use by being administered to human beings, application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal,
(ii) in relation to veterinary drugs, application to the skin, hair, fur, feathers, scales, hoof, horn, ear, eye, mouth or mucosa of the throat or prepuce,
in either case 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 in relation to paragraph (i) in this definition 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 (W/W), weight in volume (W/V), volume in weight (V/W) or volume in volume (V/V) as appropriate;
"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 (Prescription Only) Order 1980(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
(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 3 and 4—
(a) the following abbreviations are used:
"g" for grame,
(a) S.I. 1980/1921.
"iu" for international unit of activity,
"meg" 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.—(1) The descriptions and classes of medicinal products specified in paragraphs (2) and (3) are hereby specified as 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.
(2) With regard to products that are for use by being administered to human beings, the descriptions and classes of medicinal products referred to in paragraph (1) are—
(a) medicinal products specified in Schedule 1;
(b) medicinal products in respect of which there has been granted a product licence of right, and which fall within a class specified in Schedule 3 but which do not fall within a class specified in Schedule 3 but which do not fall within a class specified in Part I of Schedule 6; 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 prescription only medicines or 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.
(3) With regard to veterinary drugs, the descriptions and classes of medicinal products referred to in paragraph (1) are—
(a) veterinary drugs specified in Schedule 2; and
(b) veterinary drugs in respect of which there has been granted a product licence of right, and which fall within a class specified in Schedule 4 but which do not fall within a class specified in Part 11 of Schedule 6.
Automatic machines section of the general sale list
3. The medicinal products specified in Schedule 5 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 1977(a), the Medicines (General Sale List) Amendment Order 1979(b) and the Medicines (General Sale List) Amendment Order 1980(c) are revoked.
(a) S.I. 1977/2129.
(b) S.I. 1979/315.
(c) S.I. 1980/7.
Patrick Jenkin, Secretary of State for Social Services.
27th November 1980.
Nicholas Edwards, Secretary of State for Wales.
27th November 1980.
George Younger, Secretary of State for Scotland.
1st December 1980.
In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 3rd December 1980.
Peter Walker, Minister of Agriculture, Fisheries and Food.
(L.S.)
Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 8th day of December 1980.
N. Dugdale, Permanent Secretary.
(L.S.)
Sealed with the official seal of the Department of Agriculture for Northern Ireland this 5th day of December 1980.
J. A. Young, Permanent Secretary.
(L.S.)
Article 2 (2) (a)
SCHEDULE 1
MEDICINAL PRODUCTS FOR HUMAN USE ON GENERAL SALE BY VIRTUE OF ARTICLE 2(2)(a)
Name and product licence number of medicinal product
Acriflex Cream 3550/5901
Adexolin Vitamin Drops 3550/0002
Airbal Breathe Easy 3235/0001
Algispray 0201/5901
Alkafyl Antacid Tablets 0165/0040
Alka-Seltzer 0055/5003R
Allbee with C 550 0100/0055
Allbee with C Elixir 0100/0044
Alum 2156/5911
Aluminium Hydroxide Tablets 500mg BP 0469/0010
Amatol 2274/0001
Aneurine Hydrochloride Tablets BP 50mg 1378/5900
Aneurine Hydrochloride Tablets BP 100mg 1378/5901
Antibactic Throat Lozenges 0459/0005
Antiseptic Throat Drops
Cherry Menthol Flavour 0014/0213
Lemon Flavour 0014/0214
Menthol and Eucalyptus Flavour 0014/0212
Antiseptic Solution 0484/0011
APS Junior Aspirin Tablets 0289/0023
Aqua-Ban Tablets 2744/0001
Ascorbic Acid 50 mg 0338/0039
Ascorbic Acid 100 mg 0338/0041
Ascorbic Acid Tablets BP 50 mg 1378/5903
Ascorbic Acid Tablets BP 100 mg 1378/5904
Ascorbic Acid Tablets BP 200 mg 1378/5905
Ascorbic Acid Tablets...To continue reading
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