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news.The Health Products Regulatory Authority (The HPRA), formerly the Irish Medicines Board (IMB), published a list of 12 active substances contained in medicines currently classified as prescription-only medicines (POM) which could be safely reclassified and switched to over the counter (OTC) sale.
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This could result in a total of 34 medicines being sold through pharmacies without prescription. The list includes medicines for the treatment of migraine, acid-reflux symptoms, hay fever, cold sores, muscle pain and inflammation, fungal skin and nail infections and other inflammatory skin conditions. The HPRA is now requesting expressions of interest from pharmaceutical companies who are the Marketing Authorisation Holders (MAH) for these medicines to apply to reclassify their medicines.
According to Lorraine Nolan, Director of Human Authorisation, the HPRA, the medicines on the list are currently only available under prescription; however, in line with certain conditions, these could be reclassified to be made available for sale through pharmacies without prescription.
"This is an important development which sees the HPRA proactively inviting submissions for reclassification. It represents the outcome of measures which have been undertaken by the HPRA to explore unmet needs in the availability of non-prescription medicines in Ireland and follows recommendations made by an independent consultative panel established by the Authority to specifically assist its review of this area.
"The Authority is pleased to bring this reclassification initiative forward with this initial list of products. This will see an increase in the range of medicines that can be made available to Irish patients through pharmacies without prescription. Dependent on the nature, quality of applications and the relevant engagement process with Marketing Authorisation Holders, further lists of appropriate substances may be considered in the future".
"Our proactive stance with regard to these medicines is consistent with Irish health policy which aims, where appropriate, to provide patients with increased access to healthcare at the lowest point of complexity and cost. We look forward to commencing this engagement process with Marketing Authorisation Holders in the coming weeks", she concluded.