Title and commencement

1. This Order may be cited as the Medicines (Exemptions for Merchants in Veterinary Drugs) (Amendment) Order 2000 and shall come into force on 9th October 2000.

Amendment of previous Order

2.-(1) The Medicines (Exemptions for Merchants in Veterinary Drugs) Order 1998(3) is amended in accordance with the following paragraphs of this article.

(2) In paragraph (3) of article 6 (conditions of exemption for agricultural merchants)-

(a)at the end of sub-paragraph (a) the word "and" shall be deleted;

(b)in sub-paragraph (b), for the words "an organophosphorus sheep dip, or after 30th December 1998 if the product is a sheep dip" there shall be substituted the words "a sheep dip of any type";

(c)at the end of sub-paragraph (b) there shall be inserted the word ", and" followed by the following sub-paragraph:

"(c)if the product is an organophosphorus sheep dip, not intended for export, the sale is effected together with the provision to the buyer of-

(i)a double side laminated notice meeting the specification set out in the Schedule to this Order (unless the notice has been provided to the buyer within the previous twelve months and the agricultural merchant knows or has reasonable cause to believe that the buyer still has it available for use), and

(ii)two pairs of gloves either as described in the notice or providing demonstrably superior protection to the proposed user against exposure to the dip than would be provided by gloves as so described".

(3) For article 7 (exemption and conditions of exemption for authorisation holders relating to sale) these shall be substituted the following article:

"Exemption and conditions of exemption for authorisation holders relating to supply

7.-(1) The provisions of section 52 of the Act shall not apply to the supply (in circumstances corresponding to sale) of a veterinary drug to which this Order applies by the authorisation holder for that drug, if he complies with the conditions set out in paragraph (2) below.

(2) The conditions which must be complied with are that:

(a)the supply is free of charge and takes place at premises which are occupied by him and under his control at all times when the premises are open for business and which are capable of being secured so as to exclude the public,

(b)each veterinary drug supplied is in the container in which it was made up for supply by the manufacturer or assembler and which has not been opened since then, the product bears the manufacturer's label which has not been altered and the product is not sold after the date of expiry indicated on its label,

(c)the supply is not by self-service methods,

(d)if the product is not a horse wormer the supply is to a person who the authorisation holder knows or has reasonable cause to believe has animals under his control for the purposes of, and in the course of carrying on, a business, either as his sole business activity or as part of his business activities,

(e)if the product is a horse wormer the supply is to a person who the authorisation holder knows or has reasonable cause to believe has in his charge a horse or pony and will use the product for the treatment of the animal concerned,

(f)if the product is a sheep dip of any type, not intended for export, the supply is to a person who the authorisation holder knows or has reasonable cause to believe is the holder, or the employer of or a person acting on behalf of the holder, of a Certificate of Competence, and the authorisation holder keeps a record of the Certificate number for three years from the date of supply,

(g)if the product is an organophosphorus sheep dip, not intended for export, the supply is effected together with the provision to the recipient of-

(i)a double side laminated notice meeting the specification set out in the Schedule to this Order (unless the notice has been provided to the recipient within the previous twelve months and the authorisation holder knows or has reasonable cause to believe that the recipient still has it available for use), and

(ii)two pairs of gloves either as described in the notice or providing demonstrably superior protection to the proposed user against exposure to the dip than would be provided by gloves as so described, and

(h)the authorisation holder complies with the requirements as to records specified in article 8;

and in this paragraph "premises" includes a stall of a permanent nature at a market or agricultural showground.".

(4) In article 8(1) (records) after the word "applies" then shall be inserted the words "and which are intended for administration to animals whose flesh or products are intended for human consumption".

(5) At the end of the Order there shall be added the Schedule set out in the Schedule to this Order.

Article 2 (5)

SCHEDULESchedule to be added to the Medicines (Exemptions for Merchants in Veterinary Drugs) Order 1988

Articles 6 (3) and 7 (2)

"SCHEDULESpecification of notice on double sided laminated sheet

1. The notice shall be at least 29.8cm x 21cm with a laminated transparent cover, coloured and printed to scale on front and back substantially (subject to paragraph 2 below) in accordance with the following two diagrams:

2. The notice may be in Welsh when provided in Wales."

Explanatory Note

(This note is not part of the Order)

This Order amends articles 6 and 7 of the Medicines (Exemption for Merchants in Veterinary Drugs) Order 1998. It provides for gloves and laminated sheets with safety warnings to be supplied by agricultural merchants on any sale or supply of organophosphorus sheep dips. It takes away the right of marketing authorisation holders to sell veterinary medicines directly to users (though reserving their right to supply them free, subject to similar requirements in relation to such dips).

This Order also amends article 8 of the 1998 Order so as to provide that records of sales are to be kept only for products to which the 1998 Order applies which are intended for food-producing animals. Article 8 implemented Article 50b.2 of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ No. L317, 6.11.81, p.1), which sets out provisions for record keeping by retailers of those products, and this Order derogates from the 1998 Order to the extent authorised by Article 50b.3 of that Directive.

A Regulatory Appraisal has been prepared and a copy has been placed in the library of each House of Parliament. Copies can be obtained from the Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS.