Field Safety Notices: 09-13 February 2026

Updated safety and educational materials are now available to support the implementation of the regulatory measures announced in the November 2023 National Patient Safety Alert and the September 2024 Drug Safety Update. They also include previous updates to product information on the risk of low birth weight in children exposed to valproate during pregnancy.

The pilot will help sponsors prepare for a new substantial modifications process under upcoming regulations, with responses delivered within 14 days.

Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.

A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.

This privacy notice describes how we collect and use your personal information, in accordance with the Data Protection Act and the General Data Protection Regulation.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.