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 30th July 2004.
(2) In these Regulations—
“the principal Regulations” means the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971(1).
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(2).”.
Signed by authority of the Secretary of State for Health
Warner
Parliamentary Under Secretary of State,
Department of Health
29th 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
30th 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
30th June 2004