The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
These Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the 2004 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 humans.