The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009
These Regulations make further amendments to the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994, the Medicines for Human Use (Clinical Trials) Regulations 2004 and the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 in connection with the transposition of Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (“the 2001 Directive”) and Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.