Regulatory and Ethical Procedures

The Regulations (European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004) (S.I. 190 of 2004) came into force on May 1st, 2004, to implement the provisions of the EU's Clinical Trials Directive (2001/20/EC) in Ireland.

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 Irish Medicines Board is the Competent Authority responsible for approval of CTA's in Ireland. Applications consist of the Eudract application form, the IMB's form for additional national requirements for clinical trial authorisation and all supporting documents as detailed in the guidance drawn up and published by the European Commission under Article 9.8(a) of the Directive, on the format, contents and documentation to be submitted in support of a request for authorisation of a clinical trial.

A Clinical Trials Sub-Committee meets to review all applications. This committee is a sub-committee of the Advisory Committee for Human Medicines. The clinical trials sub-committee meets on the fourth Thursday of each month and applications are required to 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. The IMB will, within 60 days of receipt of a valid application, give a written notification to the sponsor of approval/non approval of the application.

Applications for ethical review of clinical trials are made by submitting the local ethics application form, a completed Eudract application form if required and by sending the completed forms, together with supporting documents and details of all participating Investigator sites, to a research ethics committee that has been recognised in accordance with Part 2 of SI No. 190 of 2004. Only one application for an ethics committee opinion can be made in relation to a trial, regardless of the number of trial sites at which the trial is to be conducted.

Most ethics committees meet monthly and applications should be submitted 3-4 weeks in advance of the meeting. The ethics committees will, within 60 days of receipt of a valid application, give written notification to the sponsor of approval/non approval of the application.

In Ireland, regulatory and ethical submissions can be made in parallel.

Health Care System in Ireland

Up until January 2005, health and personal social services in Ireland were delivered by ten health boards, located around the country. On 1 January 2005 the Health Service Executive (HSE) took over full responsibility for running the country's health and personal social services. This means that from 1 January 2005 all health boards in Ireland were abolished.

The Government, the Minister for Health and Children and the Department of Health and Children are at the head of health service provision in Ireland. Each year, the Department of Health and Children allocates funding to the Health Service Executive (HSE). Each Health Service Executive (HSE) Area then make decisions about how they will distribute available resources to the agencies in their area. The Department takes account of a range of factors in determining what proportion of the funding should be allocated to each HSE Area. These factors include the cost of providing services in the previous year, pay costs, health service developments and funding for agreed specific items.

There are two levels of entitlement to health services in Ireland - Category One (full eligibility) or Category Two (limited eligibility). Eligibility for health services usually depends on your income. It is not connected to Pay Related Social Insurance (PRSI) contributions. A medical card issued by a Health Service Executive (HSE) Area in Ireland enables the bearer to receive certain health services free of charge. Everyone in Ireland that is over 70 years that is normally resident in Ireland, is entitled to a medical card regardless of means.

If you have a medical card, you are entitled to free General Practitioner (family doctor) services; prescribed drugs and medicines (with some exceptions); in-patient public hospital services; out-patient services; dental, optical and aural services; medical appliances; maternity and infant care services.
Unless you have a medical card, visits to General Practitioners (GPs) in Ireland are not free. The General Practitioner Visit Card was announced in 2005 as a new initiative to assist those who did not qualify for a medical card on income grounds but for whom the cost of visiting a GP was often prohibitively high.

Local office/staff

ECRON / Java
Unit 1.17 NovaUCD, University College Dublin, Belfield, Dublin 4, Ireland
Phone: +353 (1) 71 63 640 Fax: +353 (1) 71 63 641


Irish Medicines Board
Irish Medicines Board Clinical Trial Section
Department of Health and Children
Department of Health and Children Information Page on Implementation of EU Directive on GCP in Clinical Trials