Medicines (Exemptions from Restrictions on the Retail Sale or Supply of Veterinary Drugs) Order 1985
| Jurisdiction | UK Non-devolved |
| Citation | SI 1985/1823 |
| Year | 1985 |
1985 No. 1823
MEDICINES
The Medicines (Exemptions from Restrictions on the Retail Sale or Supply of Veterinary Drugs) Order 198525thNovember 1985
9thDecember 1985
1stJanuary 1986
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), (2A) and 129(4) of the Medicines Act 1968(a) and now vested in them(b), and of all the 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 in accordance with section 129(6) of the said Act and with the consent of the Treasury, hereby make the following order:—
Title and commencement
1. This order may be cited as the Medicines (Exemptions from Restrictions on the Retail Sale or Supply of Veterinary Drugs) Order 1985 and shall come into operation on 1st January 1986.
Interpretation
2.—(1) In this order, unless the context otherwise requires—
"the Act" means the Medicines Act 1968;
"agricultural requisites" means things used in the cultivation of the soil or in the keeping of animals for the production of food or as game and equipment used for the collection of produce from animals kept for the production of food and things used for the maintenance of such equipment, and includes any protective clothing but does not include any other kind of human apparel;
"the Department" means the Department of Health and Social Services for Northern Ireland;
(a) 1968 c. 67; section 57(2A) was inserted by section 14 of the Animal Health and Welfare Act 1984 (c.40).
(b) In the case of the Secretaries of State concerned with health in England and Wales by virtue of S.I. 1969/388, in the case of the Secretary of State concerned with agriculture in Wales by virtue of 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).
"the Department's register" means the register of merchants in veterinary drugs kept by the Department under Article 3(7);
"dosage unit" means—
(a) where a veterinary drug is in the form of a tablet or capsule or is an article in some other pharmaceutical form that tablet, capsule or other similar article, and
(b) where a veterinary drug is not in any such form, the quantity of the drug which is used as the unit by reference to which the dose of the drug is measured;
"external use" means application to the skin, hair, fur, feathers, scales, hoof, horn, ear, eye, mouth or mucosa of the throat or prepuce, when local action only is necessary and extensive systemic absorption is unlikely to occur;
"maximum strength" means either the maximum quantity of the substance by weight or volume contained in a dosage unit of a veterinary drug or the maximum percentage of the substance contained in a veterinary drug calculated in terms of weight in weight, weight in volume, volume in weight or volume in volume, as appropriate;
"the Minister" means the Minister of Agriculture, Fisheries and Food;
"qualifying business" means a business involving in whole or in part the retail sale of agricultural requisites;
"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;
"the Society" means the Pharmaceutical Society of Great Britain;
"the Society's register" means the register of merchants in veterinary drugs kept by the Society under Article 3(7);
"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(b).
(a) S.I. 1971/1450.
(b) For the current relevant order see S.I. 1984/768.
(2) A reference in this order to a numbered Article or Schedule is to the Article of, or Schedule to, this order which bears that number.
Exemption for merchants in veterinary drugs
3.—(1) The restrictions imposed by section 52 of the Act (restrictions on sale or supply of medicinal products not on a general sale list) 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 of that veterinary drug, by a specially authorised person or by a person who is for the time being carrying on a qualifying business, if—
(a) that veterinary drug either—
(i) is a veterinary drug consisting of or contained in a medicinal product in respect of which there has been granted a product licence, being a licence of right and is not on a general sale list by reason of its consisting of 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
(b) the conditions contained in this Article 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, either as his sole business activity or as a part of his business activities;
except that, when a person has lawfully purchased a veterinary drug on the premises of the seller, condition (c) above 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 specified 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) any other restriction is specified in the fifth column of the said Part A, that drug shall not be sold by retail except in compliance with the restriction so specified.
(5)(a) 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 containing the particulars specified in sub-paragraph (b) below and shall keep such record for a period of two years from the date of the sale.
(b) The particulars referred to in sub-paragraph (a) above are—
(i) the date on which the veterinary drug was sold;
(ii) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the veterinary drug sold; and
(iii) the name and address of the person to whom the veterinary drug was sold.
(6) No person shall, in the course of a qualifying business carried on by him, sell by retail any veterinary drug such as is described in paragraph (1)(a)(i) or (ii) above unless his name is entered in the Society's register or the Department's register in respect of each premises on which the drug is sold or stored.
(7)(a) The Society and the Department shall keep, for the purposes of paragraph (6) above, a register of persons as being persons entitled, in the course of qualifying businesses carried on by them, to sell by retail on premises in respect of which their names are entered in the register, any veterinary drug such as is described in paragraph (1)(a)(i) or (ii) above free from the restrictions imposed by section 52 of the Act, if and so long as the conditions contained in this Article are complied with.
(b) Details of premises used for the storage of any veterinary drug such as is described in paragraph (1)(a)(i) or (ii) above at a different postal address to that of premises used to sell by retail such drug shall be recorded in a register kept under sub-paragraph (a) above.
(8) Where a person who, whilst carrying on a qualifying business elsewhere than in Northern Ireland, makes an application in writing to the Society for his name to be entered in the Society's register in respect of any premises on which any veterinary drug such as is described in...
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