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Dáil Éireann debate -
Tuesday, 16 Jun 1998

Vol. 492 No. 4

Written Answers. - Drug Availability.

Alan Shatter

Question:

215 Mr. Shatter asked the Minister for Health and Children when the drug Viagra will be available in Ireland; whether it will be available on prescription to medical card holders; and the assessment, if any, made by his Department as to the estimated annual cost of the provision of this medication to medical card holders. [14226/98]

The preparation, Viagra, is not as yet licensed for marketing in this country. However, I understand that an application for a marketing authorisation for the product under the centralised European procedure has been submitted to the European Agency for the Evaluation of Medicinal Products. As this application is currently under assessment, I am unable to say if or when such a licence will be granted. If a licence is granted in respect of Viagra, the company may then apply to the Department for reimbursement and pricing approval in respect of the inclusion of the product of the general medical services scheme. This application must include a ‘summary of product characteristics' and a proposed pricing structure for the product. In the absence of an application from the company concerned and the necessary "summary of product characteristics", I am not in a position to say whether this product will be reimbursable on the GMS. The question of pricing the product will not arise until the product has been granted its marketing authorisation. In these circumstances I am not in a position at this stage to estimate the cost of this product to the Irish market. I am, however, keeping the position under review.

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