Question to the Department of Health and Social Care:

To ask Her Majesty's Government what process will be followed for Northern Ireland in circumstances where the Medicines and Healthcare products Regulatory Agency approves a licence for a medicine but such approval has not been given by the European Medicines Agency.

We are committed to maintaining parity of access to medicines across the United Kingdom. In circumstances where the approval dates for products in Great Britain and Northern Ireland differ, doctors can prescribe medicines outside of the label in areas of unmet medical need. The General Medical Council provides clear recommendations to physicians on prescribing medicines which they consider is in the patient’s best interest but may not carry the specific indication. We continue to work with colleagues in Europe to ensure that approval for medicines in Great Britain and Northern Ireland are aligned in the future.