1983 No. 1725
The Medicines (Applications for Manufacturer'S and Wholesale Dealer'S Licences) Amendment Regulations 1983
Made
Laid before Parliament
Coming into Operation
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Scotland and in Wales, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland, and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of the powers conferred by section 18(1) of the Medicines Act 1968 and now vested in them1, and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these regulations in accordance with section 129(6) of the said Act, hereby make the following regulations:—
Title and commencement1
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.
Amendment of regulations2
The Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Regulations 19712 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 Act3;
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 19714, 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.
In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 26th October 1983.
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 10th day of November 1983.
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 10th day of November 1983.