MHRA-GMDP contains information relating to manufacturing and wholesale distribution authorisations, API registrations and GMP/GDP certificates.

The MHRA products website allows you to find: The leaflets which are provided with medicines; The description of the medicinal product’s properties and how it can be used; Scientific reports about marketing authorisations for medicines; You can look for any word, phrase or Product Licence number (PL) using the search tool.

Use this service to get scientific advice from the Medicine and Healthcare products Regulatory Agency (MHRA). The MHRA has published guidance on the types of scientific advice it offers. There is a fee to receive scientific advice.

For queries related to PIP, PSUR or MHRA-GMDP, please refer to the FAQ page. For all other technical support or queries, contact [email protected].

Due to the restrictions caused by COVID-19, the period of validity GMP and GDP certificates issued by MHRA is automatically extended until the end of 2024, except where clarifying remarks in the document state otherwise.

2014年9月1日 · The first is to submit a substantial amendment to the MHRA to update your IB and change your RSI. The second option is to conduct and fully document a risk assessment of the changes and if you feel that you can justify not using the new RSI to again document it and continue with the old IB.

komtur pharmaceuticals uk limited, unit 2 business innovation centre, binley business park, harry weston road, coventry, cv3 2tx, united kingdom 20/03/2025 UK WDA(H) 59209

MHRA Homepage for reporting of suspected side effects or adverse drug reactions to any medicines or vaccines, as well as medical device incidents

2024年12月20日 · UK MIA(IMP) 54923: 2: Name of authorisation holder: ADVENT BIOSERVICES LTD: 3: Address(es) of manufacturing site(s) ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM. 4: Legally registered address of authorisation holder: ADVENT BIOSERVICES LTD, SAWSTON …

2024年2月21日 · Following a review, the Commission on Human Medicines has recommended further restrictions to valproate use to reduce avoidable harm which were introduced by the MHRA in January. Please see the attached letter from Chief Medical Officers across the UK regarding the recently announced sodium valproate safety measures.