Ireland looks to switch 12 APIs from prescription to OTC medicines
A total of 34 medicines from 20 companies could be reclassified. The list includes medicines for the treatment of migraine, acid-reflux symptoms, hay fever, cold sores, fungal skin and nail infections and other inflammatory skin conditions.
The authority has requested expressions of interest from pharma companies who are the marketing authorization holders to apply for reclassification. Depending on the nature, quality of applications and the engagement process, the authority says it may consider further lists of appropriate substances in future.
The authority says once expressions of interest are submitted, it will have a clearer understanding of the potential timeframes for reclassification of the medicines. “However, we are hopeful that some of these reclassifications will be approved before the end of the year,” said Lorraine Nolan, Director of Human Authorisation.
The list has been published and guidance offered regarding the circumstances in which reclassification will be approved. The authority individually communicated with all the relevant marketing authorization holders on this matter and offered anyone interested in making an application a pre-submission meeting to discuss the application and requirements.
“This is an important development which sees the HPRA proactively inviting submissions for reclassification,” according to Nolan.
“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 list includes Felbinac, for relief of pain and inflammation; Penciclovir, for treatment of herpes simplex infections; Sumatriptan, for treating migraine; Tioconazole, for nail infections due to bacteria and fungi; and Triamcinolone, for allergic rhinitis.
Further information on the publication of the list and the process for classifying the method of sale and supply of medicines is available at www.hpra.ie. The HPRA was formerly the Irish Medicines Board.
