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The HPRA has commenced a formal regulatory procedure to determine the appropriate method of sale for codeine-containing medicines in Ireland. Currently, codeine-containing medicines are available in Ireland through pharmacies only and are not subject to medical prescription, subject to certain pack size restrictions.
All marketing authorisation holders have been invited to submit data supporting the method of sale specific to their product. The available data will be carefully considered to determine whether any necessary regulatory actions are required to support the safe and effective use of these medicines. Once the procedure is completed, the HPRA will communicate the outcome and any recommendations to all relevant stakeholders.
The HPRA communication can be read here.
The HSE have issued a National Patient Safety Alert on the ‘Risk of Harm from Codeine-containing Products’ which can be read here.
