Question to the Department of Health and Social Care:

To ask Her Majesty's Government what assessment they have made of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee's recommendation to revoke the marketing authorisation of ulipristal acetate as a treatment for uterine fibroids; and whether they intend to implement the same revocation in the UK.

Medicines containing ulipristal acetate for the treatment of uterine fibroids were recalled from the United Kingdom market in March 2020 and no woman should have been treated with these medicines since then.

The Medicines and Healthcare products Regulatory Agency (MHRA) has assessed the data underpinning the European Union Pharmacovigilance Risk Assessment Committee's (PRAC) recommendation to revoke the marketing authorisations for ulipristal acetate 5mg for uterine fibroids. Independent advice was sought from the Commission on Human Medicines Expert Advisory Group on Medicines for Women’s Health in May 2020 and UK comments on the EU assessment reports were fed into the EU review.

The EU review for ulipristal acetate 5mg is ongoing pending a final opinion expected in October 2020 from the European Medicines Agency’s Committee for Medicinal Products for Human Use on the PRAC’s recommendation, and a decision from the European Commission within three months of the Committee for Medicinal Products Opinion. The MHRA intends to act in accordance with the outcome of the EU review.