3510. Deputy Joe Neville asked the Minister for Health if an antihistamine (details supplied) is available in Ireland; if not, the reason; and if she will make a statement on the matter. [56666/26]

Medicines placed on the Irish market must be authorised by the Irish Medicines Regulator, the Health Products Regulatory Authority (HPRA) or, in the case of centrally authorised products, by the European Commission. There is also a provision for exempt medicinal products (EMPs), which are not nationally authorised by the HPRA or centrally authorised by the European Commission to be supplied by pharmacists in certain circumstances. EMPs can be supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by their individual patients on their direct personal responsibility to fulfil the special needs of those patients.

Clemastine is a first-generation antihistamine that was previously authorised in Ireland. According to information available from the HPRA, the tablet formulation was withdrawn from the Irish market in 2003, and the syrup formulation was withdrawn in 2000. Medicines may be withdrawn for commercial reasons, including where a marketing authorisation holder determines that a product is no longer commercially viable.

It is understood that Clemastine is no longer marketed in Ireland and that its withdrawal was not linked to any identified safety or efficacy concern, but rather reflected commercial considerations.

The HPRA cannot require companies to market medicinal products in Ireland, and it also has no role in relation to pricing and reimbursement. I am advised that the HPRA would be willing at any stage to engage with and to provide regulatory guidance to any company that wishes to make medicinal products available in Ireland.