Statutory Instruments
2004 No. 1678
MEDICINES
The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 2004
Made
30 June 2004
Laid before Parliament
7 July 2004
Coming into force
30 July 2004
The Secretary of State, the Department of Health, Social Services and Public Safety, and the Department of Agriculture and Rural Development, acting jointly, in exercise of the powers conferred upon them by sections 47(1) and 129(5) of the Medicines Act 1968( 1 ) or, as the case may be, those conferred by the said provisions and now vested in them( 2 ), 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, pursuant to section 129(6) of that Act, hereby make the following Regulations:
Citation, commencement and interpretation
1. —(1) These Regulations may be cited as the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 2004 and shall come into force on 30 th July 2004.
(2) In these Regulations—
“the principal Regulations” means the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971( 3 ).
Amendment of regulation 2(1) of the principal Regulations
2. In paragraph (1) of regulation 2 of the principal Regulations (interpretation) for the definition of “good manufacturing practice” substitute the following—
“ “good manufacturing practice” means the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use, the principles and guidelines of which are specified in Commission Directive 2003/94/EC 4 ) . ” .
Signed by authority of the Secretary of State for Health
Warner
Parliamentary Under Secretary of State,
Department of Health
29 th June 2004
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
D. C. Gowdy
Permanent Secretary,
Department of Health, Social Services and Public Safety
30 th June 2004
Sealed with the Official Seal of the Department of Agriculture and Rural Development
Pat Toal
Permanent Secretary,
Department of Agriculture and Rural Development
30 th June 2004
1968 c. 67 ; the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations, is defined in section 1(1) of that Act as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388 , by article 5 of, and paragraph 1(1) of the Schedule to, S.I. 1999/3142 , and by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I 2002/794 .
In the case of the Secretary of State, by virtue of articles 2(1) and 5 of, and paragraph 1(1) of the Schedule to, S.I. 1999/3142 , and articles 3(1)(c) and (7) of, and paragraph 15 to Schedule 1 to S.I.2002/794 ; and in the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, by virtue of the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) , which may now be exercised by the Departments by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c. 1) ; the Departments were renamed by virtue of article 3(4) and (6) of S.I. 1999/283 (N.I.1) .
OJ No. L 262, 14.10.2003, p.22.
OJ No. L 311, 28.11.2001, p.67.