Statutory Instruments

The European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 – S.I. no. 190 of 2004

The purpose of these Regulations is to 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 for human use

The Regulations provide that the Irish Medicines Board will exercise the functions of the competent authority for the purposes of the Directive and for the purposes of supervision and enforcement as required by the Regulations. The Regulations also introduce measures for the establishment and operation of Ethics Committees that are required to give an opinion before a clinical trial may commence. This includes arrangements for obtaining a single ethics committee opinion in the case of multicentre trials. The matters to be considered by Ethics Committees are set out in Regulation 13 of the Regulations

S.I. no. 190 of 2004