MHRA

Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).

Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.

MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.

Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025.

Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.

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.

Marketing authorisations granted in 2025.

Parallel import licences granted in 2025.

Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.

Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets (packsize 20 count). The dose instruction incorrectly states for use in 12 years and older. These general sale packs are intended for use only in adult patients (18 years and over).

A step-by-step guide on using the MORE Platform for Submissions of device related incidents.

List of Field Safety Notices from 2 to 6 June 2025.