Medicines (Exemptions from Restrictions on the Retail Sale or Supply of Veterinary Drugs) Order 1979
| Jurisdiction | UK Non-devolved |
| Citation | SI 1979/45 |
| Year | 1979 |
1979 No. 45
MEDICINES
The Medicines (Exemptions from Restrictions on the Retail Sale or Supply of Veterinary Drugs) Order 197916thJanuary 1979
19thJanuary 1979
11thFebruary 1979
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Scotland and in Wales, 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 the powers conferred by sections 57(1), (2) 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 and commencement
1. This order may be cited as the Medicines (Exemptions from Restrictions on the Retail Sale or Supply of Veterinary Drugs) Order 1979, and shall come into operation on 11th February 1979.
Interpretation
2.—(1) In this order, unless the context otherwise requires—
"the Act" means the Medicines Act 1968;
"appointed day" means 1st February 1978, being the day appointed for the purposes of Section 52 of the Act(c);
"dosage unit" means—
(a) where the veterinary drug 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, and
(a) 1968 c. 67.
(b) In the case of the Secretaries of State concerned with health in England and 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 paragraph 2(1)(b) of Schedule 1 to the Northern Ireland Act 1974 (c. 28).
(c) By the Medicines (Pharmacy and General Sale) (Appointed Day) Order 1977 (S.I. 1977/2126).
(b) where the veterinary drug is not in the form aforesaid, that quantity of the veterinary drug which is used as the unit by reference to which the dose of the veterinary drug is measured;
"external use" means application to the skin, hair, fur, feathers, scales, hoof, horn, ear, eye, mouth or mucosa of throat or prepuce, when local action only is necessary and extensive systemic absorption is unlikely to occur;
"maximum daily dose" means the maximum quantity of the substance contained in the amount of the veterinary drug for internal use which it is recommended should be administered in any period of twenty-four hours;
"maximum strength" means either the maximum quantity of the substance by weight or volume contained in a dosage unit of the veterinary drug or the maximum percentage of the substance contained in a veterinary drug 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;
"self-service methods" means any method of sale which allows a purchaser to help himself on or before payment;
"sell by retail" includes offer or expose for sale by retail and supply in circumstances corresponding to retail sale, and cognate expressions shall be construed accordingly;
"a specially authorised person" means, in relation to a veterinary drug, either—
(a) a person specially authorised, by virtue of a direction of the licensing authority under Article 3(1) of the Medicines (Exemptions from Licences) (Special and Transitional Cases) Order 1971 (a), to assemble that drug otherwise than in accordance with a manufacturer's licence, or
(b) a person specially authorised by the product licence in respect of that drug to sell the drug under the alternative product name specified in the licence;
"veterinary drug on a general sale list" means a veterinary drug of a description, or falling within a class, specified in an order under section 51 of the Act which is for the time being in force.
(2) Any references in this order—
(a) to any enactment are, unless the context otherwise requires, references to that enactment as amended or extended by or under any other enactment, and
(b) to a numbered article or schedule are references to the article or schedule so numbered in this order.
Exemptions for dealers in veterinary drugs
3.—(1) The restrictions imposed by section 52 of the Act shall not apply to the sale by retail of any veterinary drug not on a general sale list by the holder of the product licence in respect thereof, by a specially authorised person or by a person who is for the time being carrying on a business wholly or mainly comprising the sale by retail of veterinary drugs and other agricultural requisites, provided that—
(a) that veterinary drug either—
(i) is not on a general sale list by reason of its being or containing one or more of the substances classified in the first column and specified in the second column of Part A of Schedule 1, or
(ii) is specified in the second column of Part B of Schedule 1, and
(a) S.I. 1971/1450.
(b) the conditions set out in paragraphs (2) to (8) below are complied with.
(2) No veterinary drug such as is described in paragraph (1)(a)(i) or (ii) above shall be sold by retail except—
(a) in the container in which it was made up for sale by the manufacturer or, as the case may be, the assembler of the drug;
(b) in a container which has not been opened since the drug was made up for sale in it;
(c) on premises which are occupied by, and under the control of, the seller at the time of sale and which are capable of being closed so as to exclude the public; and
(d) to a person whom the seller knows, or has reasonable cause to believe, to be a person who has in his charge or maintains animals for the purposes of, and in the course of carrying on, a business, whether as his sole business activity or as a substantial part of his business activities:
Provided that, where a person has lawfully purchased a veterinary drug on the premises of the seller, condition (c) shall not apply to the subsequent delivery of that drug to that person.
(3) No veterinary drug such as is described in paragraph (1)(a)(i) or (ii) above shall be sold by retail by self-service methods.
(4) Where in relation to a veterinary drug containing one or more of the substances classified in the first column and listed in the second column of Part A of Schedule 1—
(a) a maximum strength or concentration is specified in the third column of the said Part A, that drug shall not be sold by retail except in containers or packages labelled so as to show a strength or concentration not exceeding that so specified;
(b) a pharmaceutical form is specified in the fourth column of the said Part A, that drug shall not be sold by retail except in the form so specified;
(c) a form of administration is specified in the said fourth column, that drug shall not be sold by retail except for use in the form so specified;
(d) a maximum daily dose is specified in the fifth column of the said Part A, that drug shall not be sold by retail except in containers or packages labelled so as to show a daily dose not exceeding the maximum daily dose so specified;
(e) any other restriction is specified in the sixth column of the said Part A, that drug shall not be sold by retail except in compliance with the restriction so specified.
(5) In respect of any sale by retail of any veterinary drug such as is described in paragraph (1)(a)(i) or (ii) above the seller shall make a record of the sale stating the particulars specified in paragraph (3) of Regulation 7 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1977(a).
(6) No person shall, in the course of a business carried on by him, sell by retail any veterinary drug such as is described in paragraph (1)(a)(i) or (ii) above unless—
(a) before making any such sale he, or a previous owner of the business, has notified the Pharmaceutical Society of Great Britain or, in the case of a business carried on in Northern Ireland, the Department of Agriculture for Northern Ireland, of the relevant particulars,
(a) S.I. 1977/2132, to which there is an amendment...
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