Retailers and General Sale Medicines
The Health Products Regulatory Authority (HPRA) is the Irish regulatory authority for medicinal products, medical devices and other health products including cosmetic products. The HPRA functions to protect and enhance human and animal health by approving the medicines in Ireland that meet the scientific requirements relating to quality, safety and efficacy. Only medicines that have been authorised or registered with the HPRA can be sold by retailers in Ireland. Medicines from other countries cannot legally be sold by non-pharmacy retailers.
What are General Sale Medicines?
General sale medicines are medicines that can be sold by both non-pharmacy and pharmacy retailers. Non-pharmacy retailers are retailers that are not registered as pharmacies under the Pharmacy Acts of 1875 and 1977, and include health stores, petrol service stations, supermarkets and grocery stores.
Latest list of General Sales Product Information
General sale medicines that are authorised/registered for sale in Ireland can be found in the ‘Latest list of General Sales Product Information’ and only medicines on this list can be sold in non-pharmacy retailers in Ireland.
Irish approved products carry a number in the format
- HOR0000/000/000 or
and it is important to note that only medicines with the listed name and associated authorisation or registration number can be sold. This requirement applies to both non-pharmacy and pharmacy retailers.
The sale of paracetamol containing products by non-pharmacy retailers
The ‘Latest list of General Sales Product Information’ also identifies those medicines that contain paracetamol.
It is important to note that the Medicinal Products (Prescription and Control of Supply) makes it a legal requirement that only one pack of a paracetamol containing product included in the list can be sold per retail transaction.
- This effectively means that non-pharmacy retailers may only sell one pack of a paracetamol product to a customer
Additional guidance explaining the requirements in place for the selling of paracetamol products by non-pharmacy retailers can be found in the HPRA’s Guidance Note on the Sale of Paracetamol-containing Medicinal Products by Non-pharmacy Retailers.
The rationale behind the legal restrictions controlling the sale of paracetamol products is explained in the article Suicide Prevention Awareness – Health Products Regulatory Authority (HPRA) reminds retailers of the legal requirements when selling Paracetamol.