
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.
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, Article 34 of Council Directive 75/319/EEC, Article 1 of Council Directive 89/342/EEC, Article 1 of Council Directive 89/343/EEC and Article 1 of Council Directive 89/381/EEC, Chapters II to V of Council Directive 65/65/EEC apply;”.
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 (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.”.
Signed by authority of the Secretary of State for Health
Brian Mawhinney
Minister of State,
Department of Health
22nd March 1993David Hunt
Secretary of State for Wales
22nd March 1993Fraser of Carmyllie
Minister of State, Scottish Office
22nd March 1993In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed
John Selwyn Gummer
Minister of Agriculture, Fisheries and Food
24th March 1993.Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on
F. A. Elliott
Permanent Secretary
22nd March 1993.Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on
W. J. Hodges
Permanent Secretary
22nd March 1993.