Medicines (General Sale List) Order 1977
| Jurisdiction | UK Non-devolved |
| Citation | SI 1977/2129 |
| Year | 1977 |
1977 No. 2129
MEDICINES
The Medicines (General Sale List) Order 197720thDecember 1977
1stFebruary 1978
The Secretaries of State respectively concerned with health in England and in Wales, the Secretary of State concerned with health and with agriculture in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture foi Northern Ireland, acting jointly, in exercise of powers conferred by section 51 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 may be cited as the Medicines (General Sale List) Order 1977 and shall come into operation on 1st February 1978.
(2) In this order, unless the context otherwise requires—
"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—
(a) where the 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 similar article, or
(b) where the medicinal product is not in the form as aforesaid, that quantity of the medicinal product which is used as the unit by reference to which the dose of the medicinal product is measured;
"excipient" means any substance which does not contribute directly to the pharmacological action of the medicinal product otherwise than by regulation of the release of the active ingredients;
(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 (1969 I, p. 1070)), 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).
"external use" means—
(a) in relation to medicinal products for use by being administered to human beings, application to the skin, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal,
(b) 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 necessary 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 (a) above the 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 "MOD" means the maximum quantity of the substance contained in the amount of the 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 the 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 1977(a);
and other expressions have the same meanings as in the Act.
(3) Except in so far as the context otherwise requires, any reference in this order to any enactment, order or regulations shall be construed as a reference to that enactment or order or to those regulations, as the case may be, as amended, extended or re-enacted by any other enactment, order or regulations.
(4) The rules for the construction of Acts of Parliament contained in the Interpretation Act 1889(b) shall apply for the purposes of the interpretation of this order as they apply for the purposes of the interpretation of an Act of Parliament.
General sale list
2.—(1) The descriptions and classes of medicinal products specified in paragraphs (2) and (3) below are hereby specified as products which in the opinion
(a) S.I. 1977/2127. (1977 III, p. 5820).
(b) 1889 c. 63.
of the Ministers can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist.
(2) In relation to products that are for use by being administered to human beings, the descriptions and classes of medicinal products referred to in paragraph (1) above are—
(a) medicinal products specified in column 1 of Schedule 1 to this order and in relation to those products in respect of which there is an entry in column 2 of the said Schedule, such of those products as are presented for sale in a separate and individual container or package containing not more than the quantity of dosage units specified in the said column 2; or
(b) medicinal products in respect of which there has been granted a product licence, being a licence of right, and which satisfy the provisions of Schedule 3 to this order but which do not fall within a class specified in Part I of Schedule 6 to this order; or
(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 a product that is a prescription only medicine or contains 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) In relation to veterinary drugs, the descriptions and classes of medicinal products referred to in paragraph (1) above are—
(a) veterinary drugs specified in column 1 of Schedule 2 to this order and in relation to those drugs in respect of which there is an entry in column 2 of the said Schedule, such of those products as are presented for sale in a separate and individual container or package containing not more than the quantity of dosage units specified in the said column 2; or
(b) veterinary drugs in respect of which there has been granted a product licence, being a licence of right, and which satisfy the provisions of Schedule 4 to this order but which do not fall within a class specified in Part II of Schedule 6 to this order.
Automatic machines section of the general sale list
3.—(1) The descriptions and classes of medicinal products specified in the following paragraph are hereby designated as being products which in the opinion of the Ministers can with reasonable safety be sold by means of automatic machines.
(2) The descriptions and classes of medicinal products referred to in paragraph (1) above are medicinal products specified in column 1 of Schedule 5 to this order and in relation to those products in respect of which there is an entry in column 2 of the said Schedule, such of those products as are presented for sale in a separate and individual container or package containing not more than the quantity of dosage units specified in the said column 2.
David Ennals, Secretary of State for Social Services.
15th December 1977.
John Morris, Secretary of State for Wales.
15th December 1977.
Brace Millan, Secretary of State for Scotland.
15th December 1977.
In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 15th December 1977.
John Silkin, 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 19th day of December 1977.
N. Dugdale, Permanent Secretary.
(L.S.)
Sealed with the official seal of the Department of Agriculture for Northern Ireland this 20th day of December 1977.
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) OF THIS ORDER
Column 1 Column 2
Name and product licence number of Dosage units
medicinal product per container
or package
Alkafyl Antacid Tablets 0165/0040
Altacite Suspension 0109/0041
Altacite Tabs 0109/0040
Amatol 2274/0001
Aneurin Hydrochloride Tablets BP 50 mg 1378/5900
Aneurin Hydrochloride Tablets 100 mg 1378/5901
Angiers Cold Relief Drink 0125/0062 10
Aqua-Ban Tablets 2744/0001
Ascorbic Acid Tablets BP 50 mg 1378/5903
Ascorbic Acid Tablets BP 100 mg 1378/5904
Ascorbic Acid Tablets BP 200 mg 1378/5905
Aspirin BP 300 mg Tablets 0262/0034...To continue reading
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