Paul Gogarty (Dublin Mid West, Green Party)
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Question 85: To ask the Tánaiste and Minister for Health and Children the studies which have been carried out by her Department into the risk of variant CJD from products containing or exposed to bovine-derived materials; the findings which have been published; the screening processes which are in place to ensure that such bovine-derived materials in products such as POLIO SABIN, PRIORIX or the various MMR vaccines are sourced in countries that are free from variant CJD; if her Department has ever analysed the necessity of using bovine-derived as opposed to alternative materials; and if she will make a statement on the matter. [8404/06]

Seán Power (Kildare South, Fianna Fail)
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The Irish Medicines Board is responsible for the licensing of human medicinal products in Ireland. Any company wishing to place a medicinal product on the market is required to submit a licence application, which is then assessed by the board: the board must be satisfied that the product is of an appropriate quality and that it is safe and effective for use.

In the context of variant CJD, the European Medicines Agency, EMEA, has issued a Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products. With regard to the vaccines referred to by the Deputy, any relevant materials present in these vaccines must be in compliance with the EMEA guidance, thereby minimising any theoretical risk of transmitting variant CJD.

As appropriate arrangements are in place to ensure that medicines placed on the Irish market are safe and effective, it is not proposed to undertake any studies in this area.