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MHRA Process Licensing: useful information

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Human head with cogs and binary code representing information

...Export certificates: https://www.gov.uk/export-a-human-medicine Terminated and cancelled manufacturing and wholesale dealer licences: https://www.gov.uk/government/publications/medicines-terminated-and-cancelled-manufacturing-and-wholesale-dealer-licences All other specific services or enquiries contact can be found via the following link: https://www.gov.uk/guidance/contact-mhra#contents   Medicines and...

Qualifications of suppliers and customers online: reliable or fake news?

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...everyone. We have seen evidence of companies uploading authorisations issued by regulatory bodies, including MHRA and the Home Office. While it may be convenient to provide easy access to your...

GMP & GDP Certificates: Validity Period Extended

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...To convey the information please complete and submit an Interim Compliance Report: https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice along with the relevant Inspection Report(s). Previous related messages: https://mhrainspectorate.blog.gov.uk/2022/11/08/return-to-international-gmp-inspections/ https://mhrainspectorate.blog.gov.uk/2017/10/19/international-regulators-inspecting-in-the-uk/   [1] https://www.who.int/news/item/05-05-2023-statement-on-the-fifteenth-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemic [2] An explanatory...

Refrigerated medicinal products, part 2: Transportation, packing, temperature management, the use of third party couriers and returns – some things to consider

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Refrigerated transportation

...person must be able to demonstrate evidence of “full knowledge” of the storage whilst at the unlicensed site, including transportation. Refrigerated returns from a licenced WDA site The MHRA will...

Annex 16 QP certification and batch release – frequently asked questions – part 1

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...evidence is to be made available to the QP at the site of batch certification. The consignment should have remained secure, with no evidence of tampering during storage or transportation....