The Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Amendment Regulations 1983

• Citation: S.I. 1983/1725
• Sections: 2

Section 1 Title and commencement

These regulations may be cited as the Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Amendment Regulations 1983 and shall come into operation on 21st December 1983.

Section 2 Amendment of regulations

The Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Regulations 1971 shall be amended as follows—

(a) in regulation 2(1) (interpretation)—

(i) for the definition of “imported proprietary product” there shall be substituted the following definition—

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

(ii) after the definition of “imported proprietary product” (as substituted) there shall be inserted the following definition—

“ imported ready-made veterinary drug ” means a ready-made veterinary drug imported other than from a member State of the European Communities;

(iii) for the definition of “proprietary medicinal product” there shall be substituted the following definition—

“ proprietary medicinal product ” and “ ready-made veterinary drug ” have the same meanings as in sections 7(7) and 8(4) of the Act ;

(b) in paragraph 7(5) of Schedule 1 (particulars required on an application for the grant of a manufacturer's licence) after the words “in paragraph 16(3)” there shall be inserted the words “or 17(3), as the case may be” ;

(c) in paragraphs 3(e) and 6 of Schedule 2 (particulars required on an application for the grant of a wholesale dealer's licence) after the words “imported proprietary products” wherever they occur in those paragraphs there shall be inserted the words “or imported ready-made veterinary drugs” ; and

(d) for paragraph 9 of Schedule 2 there shall be substituted the following paragraph—

(9) Where the licence is to relate to an imported proprietary product or an imported ready-made veterinary drug and is to be subject to the provisions of paragraph 8 or 9, as the case may be, of Schedule 3 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 , the name and address and degrees, diplomas or qualifications of the person who is to carry out the functions specified in the appropriate said paragraph.