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Medicinal Products

Dáil Éireann Debate, Tuesday - 25 October 2022

Tuesday, 25 October 2022

Ceisteanna (687)

Thomas Gould

Ceist:

687. Deputy Thomas Gould asked the Minister for Health if an official group has been established to review the codeine prescription processes; the membership of this group; the parameters of the group; the date of its establishment; and the date that the group will report back. [53433/22]

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Freagraí scríofa

The Department of Health and its agencies are actively monitoring the evolving evidence in relation to codeine-containing medicines, including the merits of any necessary further steps to support the safe and effective use of these medicines.

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 will engage with relevant 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.

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