The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 2004

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

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (“the principal Regulations”) which specify the standard provisions of licences issued under the Medicines Act 1968. In particular, Schedule 2 to the principal Regulations specifies the standard provisions of licences granted to manufacturers of medicinal products, including the requirement in Article 46 of Directive 2001/83/EC(5), relating to medicinal products for human use, to comply with “good manufacturing practice”. These Regulations substitute a new definition of “good manufacturing practice” and so implement Commission Directive 2003/94/EC, in so far as that Directive relates to the manufacture of medicinal products for human use, other than “investigational medicinal products” (products used in clinical trial).

A full regulatory impact assessment has not been produced for this instrument as it has no impact on the costs of business. A Transposition Note in relation to the implementation of Commission Directive 2003/94/EC has been placed in the libraries of both Houses of Parliament.

(1)

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.

(2)

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).

(3)

S.I. 1971/972.

(4)

OJ No. L 262, 14.10.2003, p.22.

(5)

OJ No. L 311, 28.11.2001, p.67.