The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006

Amendment of regulation 2 of the principal Regulations

2.  In regulation 2 of the principal Regulations (interpretation), in paragraph (1)—

(a) in the definition of “chief investigator”, in sub-paragraph (b), omit “care”;

(b) for the definition of “EEA State” substitute the following definition—

““EEA State” means a Member State, Norway, Iceland or Liechtenstein;”;

(c) omit the definition of “EEA Agreement”; and

(d) after the definition of “export”, insert the following definition—

““the GCP Directive” means 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(1);”.

(1)

OJ No. L91, 9.4.2005, p.13.