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Irish Regulators Recommend 34 Drugs for OTC Use

July 25, 2014

Two pharmaceutical industry groups are welcoming a recommendation by Irish regulators that could allow as many as 34 drugs to be sold through pharmacies without a prescription.

Ireland’s Health Products Regulatory Authority (HPRA) has issued a list of 12 active substances contained in the drugs, which could be reclassified from prescription-only to over-the-counter.

The list includes drugs to treat migraine, acid-reflux symptoms, hay fever, cold sores, muscle pain and inflammation, fungal skin and nail infections, and other inflammatory skin conditions.

The Irish Pharmaceutical Healthcare Association (IPHA), which represents the international research-based pharmaceutical industry in the country, says if the listed drugs are switched to non-prescription status, it would result in more efficient use of healthcare services and better use of pharmacists’ skills.

The Irish Pharmacy Union (IPU), which represents 2,100 community pharmacists, also supports the proposal, adding the reclassification of drugs is significant step in assisting patients to manage their own health and well-being with the advice of a pharmacist.

The HPRA now is seeking the interest of drugmakers with marketing authorization for the listed drugs to apply for reclassification. The agency didn’t give a timeframe for making any Rx-to-OTC switches, but noted that additional drugs could be added to the list. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.