Terence Flanagan (Dublin North East, Independent)
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483. To ask the Minister for Health his plans to review the items which require a prescription; and if he will make a statement on the matter. [29711/15]

Kathleen Lynch (Cork North Central, Labour)
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Under the medicines legislation, the Health Products Regulatory (HPRA) is responsible for determining the method of sale and supply of medicines in Ireland. EU and Irish law lays out the circumstances under which a medicine must be subject to prescription including the risk of side effects if a medicine is used without medical supervision or the risk of incorrect or misuse of a medicine.

The reclassification of the method of sale and supply of medicines is a specific area of focus for the HPRA. The HPRA has been proactively reviewing the classification of medicines since 2014. Prescription only medicines (POM) can in certain circumstances be reclassified from prescription only medicines to medicines that are available over the counter in pharmacies (OTC) under the supervision of a pharmacist. These circumstances include the availability of information on the safe use of the medicine. Medicines which are available as OTC products can also be reclassified in certain circumstances to be made available for general retail sale status (GSL) in pharmacies and supermarkets, without the supervision of a healthcare professional.

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, gastrointestinal 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 POM to OTC status, and OTC to 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. The HPRA is continuing to work with the industry in order to progress the necessary submissions and will continue to proactively review the reclassification of medicines.