Written answers

Tuesday, 23 June 2015

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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438. To ask the Minister for Health if he will provide details of switching of medications from a prescription to a non-prescription basis by the Health Products Regulatory Authority; if 12 potential switches have been identified; if a further eight are to be published; and if he will make a statement on the matter. [24771/15]

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour)
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Reclassification of the method of sale and supply of medicines is a specific area of focus for the Health Products Regulatory Authority (HPRA). In July 2014, the Authority published a group of 12 substances which it considered suitable for reclassification. These related to over 30 medicines used for the treatment of a variety of conditions including migraine, gastro-intestinal disorders, dermatological conditions and others. Medicines containing these substances can, in certain circumstances be reclassified to be made available over the counter in pharmacies and supplied without prescription.

In addition to this initial publication of 12 substances, the HPRA in December 2014 identified a further group of substances suitable for reclassification. These included reclassification from both "prescription only medicine" (POM) to "over the counter in pharmacy" (OTC) status, and OTC to "general retail sale" (GSL) status.

There were 6 POM to OTC substances. These substances cover medicines used in treatment areas such as irritable bowel syndrome, psoriasis, migraine and topical treatments for inflammatory conditions in muscles, and joints.

There were 7 OTC to GSL substances. These substances cover a range of medicines primarily used topically for the treatment of: minor burns and scalds; insect bites and stings; inflammation and pain in muscles and joints; mild acne; hair loss in baldness. They also include medicines used in the treatment of eye irritation associated with hay fever and oral rehydration salts.

The HPRA has directly communicated with the marketing authorisation holders for the above products (32 products in total) with a view to determining interest in the submission of reclassification applications and possible timelines for this. The HPRA has to date received 35 expressions of interest in relation to reclassification of all of the medicines involved and is working closely with industry on this matter.

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