GovWire

List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

Information for healthcare professionals and the public on Moderna's bivalent vaccines. Information on the original Spikevax COVID-19 vaccine can found on a separate page (link below)

Information for healthcare professionals and the public about the adapted Spikevax XBB.1.5 vaccine

Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.

Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.

Marketing authorisations granted in 2024

Parallel import licences granted in 2024

A. Menarini Farmaceutica Internazionale Srl is recalling a specific batch as a precautionary measure due to the distribution of Invokana 300mg in Northern Ireland in packaging intended for the Greek market.

MHRA performance metrics for clinical trials and established medicines assessment.

The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.

List of Field Safety Notices from 8 to 12 April 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).

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

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

List of Field Safety Notices from 2 to 6 October 2023.

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

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

How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.

Accord-UK Ltd is recalling a specific batch of Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery) as a precautionary measure due to the internal tablet blister strips being printed with an incorrect expiry date.

How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.

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

Performance data relating to the handling of Freedom of Information requests to the Medicines and Healthcare Regulatory Agency (MHRA).

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 April 2024) approved the medicine fosdenopterin (Nulibry) to treat the genetic disease Molybdenum Cofactor Deficiency (MoCD) Type A

A list of authorised orphan medicinal products registered by the UK Licensing Authority.