Clinical Trial - Licensing

Clinical trials in Ireland are governed by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI No 190 of 2004.

The Regulations transposed into Irish law the provision of Council 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 supersede the Control of Clinical Trials Acts 1987 – 1990 for clinical trials using medicinal products.

Applications for authorisation of clinical trials should be made to the Irish Medicines Board. A Clinical Trials Subcommittee meets to review all applications. This committee is a subcommittee of of the Advisory Committee for Human Medicines.

The clinical trials subcommittee meets once a month and applications should be submitted two weeks before the meeting. After the meeting and after any queries are resolved, applications are approved by the Management Committee of the IMB which meets every week.

Submission of Academic Clinical Trial Investigation Applications

When submitting academic-led clinical trial investigations, in circumstances where there is no financial support for the conduct of the clinical trial, the investigator may be entitled to a fee waiver. This request must be clearly stated in the covering letter.

If you have any further questions regarding this topic please contact customerservices@imb.ie or phone the Irish Medicines Board at +353-1-6764971

The Irish Medicines Board - www.imb.ie

Clinical Trial - Licensing