Dáil Éireann Debate, Thursday - 23 February 2023
266. Deputy Aindrias Moynihan asked the Minister for Health the reason for shortage in supply of a medication prescribed for HRT (details supplied); if he was aware that individuals currently have to go to Northern Ireland to get their prescriptions fulfilled for this product; and if he will make a statement on the matter. [9354/23]
View answerOvestin (estriol) 1mg per gram Vaginal Cream is authorised to be marketed in Ireland, however the company who holds the authorisation (Aspen Pharma Trading Ltd) does not currently market this medicinal product in Ireland and has not done so for a number of years. A company cannot be compelled to market any medicinal product in Ireland.
A number of other HRT medicinal products are authorised and marketed in Ireland. In the event that the patient’s doctor wishes to prescribe Ovestin for his/her patient, Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations includes an exemption which enables practitioners to prescribe this as an exempt medicinal product (EMP) under that practitioners direct responsibility, in order to fulfil the special needs of that specific patient. If a valid prescription is issued for an EMP in line with the above Regulations, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription.
As EMPs have not been granted a marketing authorisation in Ireland by the HPRA, they would not be assessed by the HPRA for quality, safety or efficacy. If sourced in response to a bona fide unsolicited order as a licensed product from another market these medicines will have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in that country carried out by the respective competent authority for medicines in that state.
