Citation, commencement and interpretation

1.-(1) These Regulations may be cited as the Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Amendment Regulations 1993, and shall come into force on 14th April 1993.

(2) In these Regulations, "the principal Regulations" means the Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Regulations 1971(4).

Amendment of regulation 2 of the principal Regulations

2. In paragraph (1) of regulation 2 of the principal Regulations (interpretation), after the definition of "imported ready-made veterinary drug" there shall be inserted the following-

• ""member" in the expression "member State" means a member of the European Economic Community;"

""product to which Chapters II to V of the 1965 Directive apply" means a medicinal product to which, in accordance with Article 2 of Council Directive 65/65/EEC as amended(5), Article 34 of Council Directive 75/319/EEC(6), Article 1 of Council Directive 89/342/EEC(7), Article 1 of Council Directive 89/343/EEC(8) and Article 1 of Council Directive 89/381/EEC(9), Chapters II to V of Council Directive 65/65/EEC apply;".

Amendment of Schedule 2 to the principal Regulations

3. Schedule 2 to the principal Regulations (particulars required on an application for the grant of a wholesale dealer's licence) shall be amended by inserting after paragraph 8 the following paragraphs-

"8A. Where the licence is to relate to products to which Chapters II to V of the 1965 Directive apply, the name and address and degrees, diplomas or qualifications of a responsible person who is to carry out the functions specified in paragraph 7A(2) of Schedule 3 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971(10) (in this and the following paragraph referred to as "the Standard Provisions Regulations").

8B. Where the licence is to relate to products to which Chapters II to V of the 1965 Directive apply, details of an emergency plan which satisfies the requirements of paragraph 4A of Schedule 3 to the Standard Provisions Regulations.

8C. Where the licence is to relate to products to which Chapters II to V of the 1965 Directive apply, a statement of any arrangements for keeping records, either in the form of invoices or on computer or in any other form, relating to all products received or dispatched.".

Explanatory Note

(This note is not part of the Regulations)

These Regulations further amend the Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Regulations 1971 ("the 1971 Regulations") so implementing in part Council Directive 92/25/EEC (OJ No. L113, 30.4.92, p. 1) ("the Directive") which concerns the wholesale distribution of medicinal products for human use which are marketed within the European Community.

The Regulations insert a new requirement into the 1971 Regulations requiring applicants for wholesale dealer's licences which relate to products to which Chapters II to V of the 1965 Directive apply (a definition of which is inserted by regulation 2) to give the name and address of a responsible person who is to oversee wholesaling operations. (regulation 3, article 5(b) of the Directive).

Such applicants are also required by the amendments made by these Regulations to submit details of an emergency plan to be instituted where products are recalled (article 6(d) of the Directive) and of arrangements for keeping records relating to products received or dispatched (article 6(e) of the Directive).