Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how many applications for hormone replacement therapy implant licenses were received by the Medicines and Healthcare products Regulatory Agency in the last six months; and what steps he is taking to help ensure an ongoing supply of hormone replacement therapy implant products.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department and regulates medicine, medical devices, and blood components for transfusion in the United Kingdom, with responsibility for ensuring that medicines meet appropriate standards of safety, quality, and efficacy.

The MHRA has not received any licence applications in the last six months for a new hormone replacement therapy (HRT) implant product. The MHRA has been working closely with the current importers of the product and is also looking to encourage other applications for a licenced medicinal product. The importer Smartway has assured that there are over 13 months of product in the UK based on the currently available stocks and usage rates.

Oestrogen and testosterone HRT implants are not licenced in the UK. The Department is working closely with the MHRA to ensure safe access to these products. The Department has also reached out to specialist importers who can source unlicensed medicines in order to find alternative sources of both HRT implants for UK patients. The Department will continue to work closely with the MHRA and the National Health Service to ensure suitable alternatives are available for patients.