Dr. Elaine Breslin:

I reassure the Vice Chairman that we have been in constant contact with the Department since the referendum in May 2018. We have had numerous meetings and teleconferences. We have also been in constant contact with the HSE regarding the supply of medicines. Our most recent meeting with both groups was on Monday. It is our practice to work closely with the Department on the supply of medicines and in preparing for the supply of new medicines.

On the Vice Chairman's second question, one of the aspects we review routinely is the safety of medicines prior to their being placed on the Irish market. As she correctly said, the medicines used in the termination of pregnancy in other EU countries are long authorised and their safety is well established. It is known, for example, that the common side effects associated with these medicines are symptoms such as cramping, pain, bleeding, nausea and vomiting. Women can be allergic to these medicines and certain contraindications need to be taken account of.

With regard to the process I have described around the authorisation of medicines, the company submits a dossier to us but we then receive an independent report from the reference member state that has authorised this medicine and that has experience of the safe and effective use of that medicine. We receive that independent assessment, which is part of our review along with the dossier from the company. We can give comments back on that and the company has an opportunity to respond. The procedure must be concluded within 90 days. We have sought to conclude these procedures earlier if at all possible.