The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
These Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (the principal Regulations) which implement Directive 2001/20/EC 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 in human use. In particular, they implement Commission Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (the GCP Directive) and make other miscellaneous amendments.