Olivia Mitchell (Dublin South, Fine Gael)
Link to this: Individually | In context

Question 542: To ask the Minister for Health the reason a company (details supplied) is being prohibited by the Irish Medicines Board from introducing its cheaper product for sale in the Republic when this product is for sale at half the price across the Border; and if he will inquire the reason at the same time the Irish Medicines Board is requiring a renewal of the company's warehouse licence while prohibiting it from importing its product. [12380/12]

Róisín Shortall (Dublin North West, Labour)
Link to this: Individually | In context

The procedures to be followed for authorisation of medicinal products are set out in EU legislation. While no details have been provided by the Deputy on the product in question, I have been advised by the Irish Medicines Board that the company has made two applications to the Irish Medicines Board to market products in Ireland and these are currently under assessment by the Board. An earlier application for authorisation of a particular product was made under the incorrect procedure.

Under EU legislation, an application to market a medicinal product in a member state other than that in which it was first authorised must be made under the mutual recognition procedure. This procedure is based on the principle of the mutual recognition by EU member states of their respective national marketing authorisations. The Irish Medicines Board is unaware of any engagement with the named company regarding a wholesaler's authorisation.