The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 2004 No. 1678

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(1).”.

(1)

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