GovWire

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an adapted version of the Nuvaxovid COVID-19 vaccine that targets the Omicron JN.1 COVID-19 subvariant.

Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.

A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.

UK approved bodies listed under?Medical Devices Regulations 2002?(SI 2002 No 618, as amended) (UK MDR 2002).

Keep up to date with the latest information from the UK GLP monitoring authority.

Responses will help shape reforms that will boost UK patients’ access to safe and innovative medical products

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

The MHRA is inviting members of the public to provide their views on proposed changes to the regulatory framework for medical devices.

The Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products

Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.

LTC Healthcare has informed the MHRA that they have been selling a medicinal product containing lidocaine without authorisation from the MHRA.

Generics (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Omeprazole 40 mg Powder for solution for infusion do not contain the most up to date safety information.

Marketing authorisations granted in 2024

Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.

List of Field Safety Notices from 4 to 8 November 2024.

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

List of Field Safety Notices for 8 November 2024.

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).

Ennogen Healthcare Limited has identified that action had not been taken to ensure the Patient Reminder Card (PRC) was distributed alongside the packs of product as part of the approved Additional Risk Minimisation Measures (RMM).

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.

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

List of Field Safety Notices for 6 November 2024.

Department of Health and Social Care and MHRA register of electronic export certificates (human).