Dáil Éireann Debate, Wednesday - 8 March 2017
197. Deputy Caoimhghín Ó Caoláin asked the Minister for Health his plans for pharmaceutical standard products to be given priority over non-standardised, non-pharmaceutical products (details supplied); and if he will make a statement on the matter. [12252/17]
View answerUnder European and Irish legislation, before a medicine can be placed on the Irish market the manufacturer has to seek an authorisation from the Health Products Regulatory Authority (HPRA) or in the case of certain medicinal products, the European Medicines Agency (EMA).
A determination on an application for authorisation of a medicine is based on a rigorous scientific assessment of the application against the criteria of safety, quality, efficacy, legal and regulatory requirements.
Physicians treating a particular medical condition should opt for an authorised medicinal product(s) that has received approval for use in that specific clinical condition unless that product is contra-indicated or deemed to be clinically inappropriate for that particular patient, or where the product is no longer marketed or not available.
In the event that no authorised medicinal product is available or when authorised medicinal products are not considered to be appropriate for use in that patient, a physician may deem it appropriate to prescribe an unauthorised medicinal product for an unmet medical need for their patient. Ultimately this will be a clinical decision to be agreed between the physician and her or her patient.
