Retailers' Records for Veterinary Medicinal Products Regulations 2000
2000 No. 7
MEDICINES
The Retailers' Records for Veterinary Medicinal Products Regulations 2000
Made 7th January 2000
Laid before Parliament 10th January 2000
Coming into force 1st February 2000
The Minister of Agriculture, Fisheries and Food and the Secretary of State, being Ministers designated1for the purposes of section 2(2) of the European Communities Act 19722in relation to medicinal products, acting jointly, in exercise of the powers conferred on them by the said section 2(2), hereby make the following Regulations:
Title and commencement
1. These Regulations may be cited as the Retailers' Records for Veterinary Medicinal Products Regulations 2000 and shall come into force on 1st February 2000.
Interpretation
2.—(1) In these Regulations “the Act” means the Medicines Act 19683and the term “veterinary medicinal product” is defined as in Article 1.2 of Council Directive 81/851/EECon the approximation of the laws of the Member States relating to veterinary medicinal products4.
Record keeping for veterinary medicinal products
3.—(1) Any person who sells veterinary medicinal products by retail must comply with the requirements of paragraphs (2) to (4) below in relation to those products.
(2) For each incoming and outgoing transaction a record must be kept of—
(a)
(a) the date of the transaction,
(b)
(b) the identity of the product,
(c)
(c) the manufacturer’s batch number,
(d)
(d) the quantity received or supplied,
(e)
(e) the name and address of the supplier or recipient, and
(f)
(f) where relevant, the name and address of the prescribing veterinarian and a copy of the prescription.
(3) At least once a year a detailed audit of all such transactions must be carried out and recorded, with incoming and outgoing products reconciled with those held in stock, and any discrepancies recorded.
(4) All records kept in accordance with the preceding paragraphs must be durable, but may be kept by electronic means, and must be kept for a period of three years from the date of the transaction or audit, and made available on request to a person duly authorised in writing by any person or body having a duty of enforcement given by regulation 5 below.
Application of regulation 3
4.—(1) Regulation 3 above only applies to the sale by retail of—
(a)
(a) veterinary medicinal products intended for administration to animals whose flesh or products are intended for human consumption and in respect of which a withdrawal period must be observed, and
(b)
(b) other veterinary medicinal products intended for administration to such animals unless the products are on a general sale list within the meaning of section 51(2) of the Act5.
(2) Regulation 3 above does not apply to the sale by retail of a veterinary medicinal product by a person required to keep a record of the sale by virtue of an order made under section 57 of the Act6relating to veterinary drugs as defined in section 132(1) of the Act which is for the time being in force.
Enforcement
5.—(1) It is the duty of—
(a)
(a) the Minister of Agriculture, Fisheries and Food in relation to England,
(b)
(b) the Scottish Ministers in relation to Scotland,
(c)
(c) the National Assembly for Wales in relation to Wales, and
(d)
(d) the Department of Health, Social Services and Public Safety in relation to Northern Ireland,
to enforce the provisions of these Regulations.
(2) The Royal Pharmaceutical Society of Great Britain are under a duty concurrently with the Minister of Agriculture, Fisheries and Food in relation to England, the Scottish Ministers in relation to Scotland and the National Assembly for Wales in relation to Wales to enforce the provisions of these Regulations, except that this duty cannot be exercised in relation to the types of location specified in section...
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