The Medicines for Human Use (Clinical Trials) Regulations 2004

12.  In the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(1)—

(a)in regulation 1—

(i)in paragraph (2), after the definition of “the Act” insert the following definition—

““the Clinical Trials Directive” means 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;”,

(ii)in paragraph (5), omit “and except in the case of “clinical trial,””; and

(b)in Schedule 1, in paragraph 2, for sub-paragraph (e)(2) substitute the following sub-paragraph—

“(e)the relevant medicinal product—

(i)is manufactured, assembled or imported by the holder of an authorization referred to in Article 40 of the 2001 Directive which relates specifically to the manufacture, assembly or import of relevant medicinal products to which paragraph 1 applies; or

(ii)has been manufactured, assembled or imported as an investigational medicinal product by the holder of an authorization referred to in Article 13 of the Clinical Trials Directive”; and.