Dáil Éireann debate -
Tuesday, 20 Feb 2001

Vol. 530 No. 6

Written Answers. - Irish Medicines Board.

Bernard Allen

Question:

265 Mr. Allen asked the Minister for Health and Children if he will make a statement on the situation where a new European Union directive could radically alter the role of the Irish Medicines Board, especially the proposal that would mean that the IMB would have to accept the authorisation of medicines by other EU countries. [4779/01]

Minister for Health and Children (Mr. Martin)

The current Community system for the authorisation and supervision of medicinal products was adopted in 1993 and entered into force in 1995, when the European Agency for the Evaluation of Medicinal Products was established.

This system allowed for the introduction of a central authorisation system where authorisations are granted by the European Commission. It also allowed for the granting of authorisations nationally on a decentralised basis.

Within six years of the entry into force of the above system, the Commission undertook to publish a general report on the experience acquired as a result of the operation of the new regulatory procedures for medicinal products introduced in 1995. For this purpose consultants were commissioned by the European Commission to carry out an assessment of the procedures and to report back to the Commission on the matter. The report is now under examination by the European Commission and may result in further Community legislation.