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Medicinal Products

Dáil Éireann Debate, Tuesday - 1 February 2022

Tuesday, 1 February 2022

Questions (664)

Pa Daly

Question:

664. Deputy Pa Daly asked the Minister for Health his position in relation to a drug (details supplied) and for the approval of the drug for use here; and if he will make a statement on the matter. [4397/22]

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Written answers

The Health Products Regulatory Authority (HPRA), which is the competent authority for medicinal products in Ireland, has advised that Cariban is currently not licensed for use in Ireland, but that two similar products, Xonvea (doxylamine 10 mg and pyridoxine 10 mg) and Navalem (doxylamine 10 mg and pyridoxine 10 mg), have been licensed for use in Ireland. However, the companies holding the authorisations/licences have not marketed the products in Ireland to date, and the HPRA cannot compel a company to market a medicinal product.

To be considered for a license in Ireland, the company marketing the product would need to make an application to the HPRA. After a thorough evaluation of all the supporting evidence, and if the benefits of the product outweigh the known and potential risks, a license may be issued.

Where a medicine is not authorised in Ireland, a licensed wholesaler may import it if it has been prescribed by a doctor for a patient under his/her care, on his/her direct responsibility, and to meet the specific needs of a patient. The decision to prescribe or not prescribe any treatment for an individual patient is a decision for the treating clinician, in consultation with their patient.

The responsibility for the clinical use of unlicensed medicines lies with the prescriber. In accordance with the Medical Council’s Guide to Professional Conduct and Ethics, medical practitioners must ensure as far as possible that any treatment, medication or therapy prescribed for a patient is safe, evidence-based and in the patient’s best interests. This applies equally to licensed and unlicensed medicinal products.

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