Ruth Coppinger (Dublin West, Socialist Party)
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108. To ask the Minister for Health in order to honour Ireland's positive human rights obligation not to interfere with the right to obtain the highest possible standard of health, if he will make the appropriate changes to allow mifepristone and misoprostol to be available here, in view of their inclusion on the World Health Organization's list of essential medicines. [42794/14]

Kathleen Lynch (Cork North Central, Labour)
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The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland. Medicinal products can only be placed on the market in Ireland after a marketing authorisation is granted by the HPRA following an application from the manufacturer. Medicines may also be authorised for use across Europe by virtue of a centralised marketing authorisation issued by the European Commission on behalf of the EU. In both cases, such medicines are entitled to be marketed in Ireland under the terms of their marketing authorisations. A pharmaceutical company may make an application to the HPRA for a marketing authorisation for a product to facilitate its use on an authorised basis in a manner which is in compliance with current legislation.

The conditions of the marketing authorisation are laid down in the product information which accompanies and forms part of the marketing authorisation. Authorised medicines containing misoprostol are available in Ireland under the brand names Cytotec™ and Mysodelle™. Cytotec is a tablet containing 200 micrograms of misoprostol which is indicated for the management and prophylaxis of peptic ulcers associated with the use of non-steroidal anti-inflammatory medicines. It is also indicated in the short-term management of duodenal and gastric ulcers. Mysodelle is a vaginal device containing 200 micrograms of misoprostol and is indicated for the induction of labour in women with an unfavourable cervix from 36 weeks of pregnancy in whom induction of labour is clinically indicated. There are currently no products containing mifepristone authorised in Ireland nor has any application to authorise such a product been received.