1246. Deputy Colm Burke asked the Minister for Health if he has considered restricting the over-the-counter sale of codeine; and if he will make a statement on the matter. [12611/23]

1247. Deputy Colm Burke asked the Minister for Health if he plans to review guidelines for the sale of codeine products to protect public health given concerns about the misuse of codeine products; and if he will make a statement on the matter. [12612/23]

1248. Deputy Colm Burke asked the Minister for Health if he has any plans to further regulate the sale of codeine containing medicinal products; and if he will make a statement on the matter. [12613/23]

Stephen Donnelly Minister for Health

I propose to take Questions Nos. 1246, 1247 and 1248 together.

Codeine is a mild to moderate opioid (narcotic) analgesic which, due to its potential for misuse, is a controlled drug under the Misuse of Drugs legislation.

As an analgesic, codeine is most often used in combination with other analgesics such as paracetamol or ibuprofen and is currently authorised in Ireland with such non-prescription products for pain relief. It is also available in single ingredient, non-prescription products, as a cough suppressant. These authorised products are available without a prescription through retail pharmacy businesses (pharmacies) only.

The Health Products Regulatory Authority, the competent authority for medicines in Ireland, are currently conducting an independent review of the method of sale and supply of codeine-containing medicinal products that are currently available without a medical prescription.

Following its completion, the Department of Health will engage with above indicated stakeholders to assess the recommendations made, including the recent recommendations from the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), to fully consider any policy changes that may be required regarding the regulation of codeine-containing medicinal products.

We can confirm that the Department of Health officials have met and will continue to meet officials in the Health Products Regulatory Authority (HPRA), Pharmaceutical Society of Ireland (PSI) and HSE to monitor the evolving evidence in relation to codeine-containing medicines, including the merits of any potential further steps to support the safe and effective use of these medicines. This includes full consideration of any policy changes that may be required regarding the regulation of codeine-containing medicinal products. Any potential change to the prescription requirements for codeine containing medicinal products must be supported by sufficient evidence.