List of Field Safety Notices from 1 to 5 September 2025.
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Falsified Mounjaro KwikPen 15mg pre-filled pens
A falsified version of Mounjaro (tirzepatide) KwikPen 15mg solution for injection has been found supplied through one online pharmacy in the UK. The falsified product is labelled with batch D873576 and applies to Mounjaro KwikPen 15mg solution for injection in pre-filled pen only.
Corporate report: Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2024 to 2025
MHRA annual report and accounts 2024 to 2025.
Clinical trials regulations: transitional arrangements
Guidance on transitional arrangements for applying for clinical trial approval.
Guidance: MMRV Vaccine Factsheet – Information for Parents and Caregivers
The MMRV vaccine will become part of the routine childhood immunisation schedule in the UK from 1 January 2026.
Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices
The MHRA is inviting members of the public to provide their views on proposed changes to the regulatory framework for medical devices.
Corporate report: MHRA Corporate Plan: 2023 to 2026 and Business Plan: 2025 to 2026
These reports outline the MHRA’s Corporate and Business Plans, detailing the agency’s strategic direction over the next three years.
