The Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Amendment Regulations 1977

• Citation: S.I. 1977/1052
• Sections: 4

Section 1 Citation, commencement and interpretation

(1) These regulations may be cited as the Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Amendment Regulations 1977 and shall come into operation on 15th July 1977.

(2) These regulations shall be read as one with the Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Regulations 1971 (hereinafter referred to as “ the principal regulations ”).

Section 2 Amendment of regulation 2(1) of the principal regulations

In regulation 2(1) of the principal regulations (definitions) after the definition of “application” there shall be inserted the following definitions—

“ imported proprietary product ” means a proprietary medicinal product imported other than from a member State of the European Economic Community;

“ proprietary medicinal product ” has the same meaning as in sections 7(7) and 8(4) of the Act, as amended

Section 3 Amendment of Schedule 1 to the principal regulations

In paragraph 7 of Schedule 1 to the principal regulations (manufacturer's licences) there shall be inserted the following sub-paragraph—

(5) The name and address and degrees, diplomas or qualifications and experience of the person who is to carry out the functions specified in paragraph 16(3) of Schedule 2 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 , as amended (“qualified person”).

Section 4 Amendment of Schedule 2 to the principal regulations

(1) In paragraph 3 of Schedule 2 to the principal regulations (wholesale dealer's licences) after sub-paragraph (d) there shall be inserted the following sub-paragraph—

(e) dealing in imported proprietary products.

(2) At the end of paragraph 6 of the said Schedule there shall be inserted the following sentence—

Where the licence is to relate to imported proprietary products the statement shall indicate the description of the medicinal products.

(3) After paragraph 8 of the said Schedule there shall be inserted the following paragraph—

(9) Where the licence is to relate to imported proprietary products and is to be subject to the provisions of paragraph 8 of Schedule 3 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971, as amended, (“qualified person”), the name and address and degrees, diplomas or qualifications and experience of the person who is to carry out the functions specified in the said paragraph.