GovWire

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 20 September 2022 and 5 May 2023.

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 13 April 2022 and 25 August 2022.

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 3 December 2021 and 29 March 2022.

Argenx BV have informed MHRA that the Patient Information Leaflet (PIL) in the affected packs incorrectly contains reference to two subcutaneous injection sites. Only subcutaneous injection to the abdomen is permitted.

Apply for and maintain registrations for the brokering of human medicines.

Register as a manufacturer, importer or distributor of active substances.

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

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

A list of authorised orphan medicinal products registered by the UK licensing authority.

A list of authorised orphan medicinal products registered by the UK licensing authority.

Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.

List of Field Safety Notices from 9 to 13 December 2024.

Guidance for healthcare establishments that manufacture medical devices in-house.

MHRA performance metrics for clinical trials and established medicines assessment.

Information on Medicines and Healthcare products Regulatory Agency spending over £25,000.

Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines

A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.

The amended regulatory framework will speed up trial approvals and encourage innovation in trial design without compromising patient safety

The MHRA register of licensed manufacturing sites: manufacturer specials - human (MS) and manufacturer specials authorisation - veterinary (MANSA) only.

Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.

List of sites granted a manufacturer or wholesale dealer licence

UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.

Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human and veterinary).

Marketing authorisations granted in 2024

Parallel import licences granted in 2024

Information on Medicines and Healthcare products Regulatory Agency spending over £25,000.

A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition.