The Medicines for Human Use (Clinical Trials) Regulations 2004

STATUTORY INSTRUMENTS 2004 No. 1031 MEDICINESThe Medicines for Human Use (Clinical Trials) Regulations 2004 Made - - - - 31st March 2004 Laid before Parliament 1st April 2004 Coming into force - - 1st May 2004 The Secretary of State, being a Minister designated(a) for the purposes of section 2(2) of the European Communities Act 1972(b) in relation to medicinal products, in exercise of the powers conferred by the said section 2(2), and of all other powers enabling him in that behalf, hereby makes the following Regulations : ARRANGEMENT OF Regulations PART 1 INTRODUCTORY and of a clinical for functions under the DirectivePART 2 ETHICS Kingdom Ethics Committees of ethics of ethics of and operation of ethics functions of the AuthorityPART 3 AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE of Part for authorisation and ethics committee of investigational medicinal products for the purpose of clinical trials(a) 1972/1811.

amended(d); “doctor” means a registered medical practitioner(e); “EEA State” means a State which is a Contracting Party to the EEA Agreement; “EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992(f) as adjusted by the Protocol signed at Brussels on 17th March 1993(g);

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  Protocol, Amended, Brussels

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