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

• Citation: S.I. 2004/1678
• Sections: 2

Section 1 Citation, commencement and interpretation

(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 .

Section 2 Amendment of regulation 2(1) of the principal Regulations

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 .