Gerry Reynolds
Ceist:438 Mr. G. Reynolds asked the Minister for Health and Children the reasons a drug (details supplied) is not licensed; and if his Department has plans to licence it in the near future. [9340/02]
Written Answers. - Irish Medicines Board.
The Irish Medicines Board is responsible for the licensing, monitoring and safety of all medicinal products in Ireland. The IMB can only licence a product after it receives an application. Following assessment of this application, the IMB must satisfy itself that the product concerned is shown to be of appropriate quality, and that it is effective and safe for the proposed indication.
In the absence of an application from a company proposing to market such a product in this country, the IMB is not in a position to initiate any action which might lead to the granting of such an authorisation.
However, the Deputy will be pleased to learn that a protocol was drawn up to set out the circumstances and conditions in which a necessary unlicensed medicine may be reimbursed by the State, where lawfully supplied. Applications for reimbursement which meet the circumstances and conditions set out in the protocol should therefore be made to the relevant agency i.e. the Gen eral Medical Services (Payments) Board or the local health board.