Clinical Trials for Medicinal Products
Clinical Trials involving Medicinal Products are covered by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004) (S.I. 190 of 2004) which implement the EU Clinical Trials Directive (2001/20/EC). The Regulations came into force on 1st May 2004.
The Regulations set out measures relating to the conduct of clinical trials on medicinal products for human use. They replace those controls that previously applied to such trials under the Control of Clinical Trials Acts, 1987 and 1990.
Aspects dealt with in the Regulations include:
- procedures for obtaining a favourable ethics committee opinion (a single ethics committee opinion is required in the case of multi-centre trials);
- procedures for obtaining authorisations for the conduct of clinical trials from the Irish Medicines Board;
- controls that are to apply to the manufacture, supply and importation of investigational medicinal products;
- obligations for the reporting of various adverse events encountered in subjects participating in clinical trials, including the recording, reporting and notifying of such events;
- obligations for compliance with standards of good clinical practice (GCP) and good manufacturing practice (GMP).
The Regulations contain provisions for the establishment of, recognition of and operation of ethics committees. These committees are required to be independent, consisting of healthcare professionals and lay members and to have responsibility to protect the rights, safety and wellbeing of human subjects involved in a trial. They are also required to provide a public assurance of that protection by, among other things, expressing an opinion on the trial protocol, on the suitability of the investigators, on the adequacy of the facilities, on the availability of insurance, indemnity or compensation and on the methods and documents to be used to inform trial subjects and to obtain their informed consent.
General Documents
- Information note on the implementation of the directive
- Application Forms see also the Guidance document (below)in MS Word format.
- Guidance on the application for recognised Ethics Committee opinion and the ethical review of clinical trials on medicinal products for human use. (Revised edition, October 2012) (PDF, 678KB)
- List of Recognised Ethics Committees
EU Documents
- European Clinical Trials Directive (2001/20/EC) (PDF)
- EudraCT Supporting Documentation
- EudraCT User Manual (Public Website)
- European Communities GCP Directive (2005/28/EC)
- European Communities GMP Directive (2003/94/EC)
National Legislation
National Legislation can be viewed under www.dohc/legislation. Relevent Statutory Instruments are as follows :
- European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004 (PDF, 300KB)
- European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No. 878 of 2004)
- European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment No. 2) Regulations 2006 (S.I. 374 of 2006)
- European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 to 2006 (Informal Codification Text)
Further Information
Further information will be published in this section of the Department of Health and Children's web-site as it becomes available.
Medicines Unit
Department of Health and Children
