
1 

(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”).
2 
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
”
3 
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”).
”
4 

(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.”.
David Ennals
Secretary of State for Social Services
13th June 1977John Morris
Secretary of State for Wales
14th June 1977Bruce Millan
Secretary of State for Scotland
16th June 1977In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 17th June 1977.
John Silkin
Minister of Agriculture, Fisheries and Food
Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 20th day of June 1977.
N. Dugdale
Permanent Secretary
Sealed with the official seal of the Department of Agriculture for Northern Ireland this 21st day of June 1977.
J. A. Young
Permanent Secretary
