Paul Gogarty (Dublin Mid West, Green Party)
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Question 254: To ask the Minister for Health and Children if there are plans to review the permission for a drug (details supplied) here, in view of the fact that it has received a black box warning by the US Food and Drink Administration; if her attention has been drawn to the research that points to significant and potentially life threatening side effects that are in excess of any standard benefits outweigh risk argument regarding usage of this long-term reproductive system controlling substance; and if she will make a statement on the matter. [23541/07]

Mary Harney (Dublin Mid West, Progressive Democrats)
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In order for a product to be considered for inclusion on the list of products available on the General Medical Services and Community Drug Schemes it must meet strict criteria as set out in Article 11.2 of Council Directive 89/105/EEC.

The product must be an 'allopathic' medicinal product which is the subject of a current product authorisation granted by the Irish Medicines Board under the Medicinal Products (Licensing and Sale) Regulations, 1998 (S.I No 142 of 1998) or an authorisation granted or renewed by the European Commission in accordance with EU Council Regulation (EEC) No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products. If the Deputy is aware of any information as to the efficacy of the product it would be advisable to contact the Irish Medicines Board immediately.