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Data, Freedom of Information releases and corporate reports
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Documents, certificate, letters, and notes available from the British embassy and consulates in the USA.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
A suite of template legal documents to support the development of mutuals.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Find a list of codes for the types of Government Department licences that can be declared for imports and exports in Data Element 2/3 (Appendix 5C).
Documents, certificates, letters and notes available at British consulates in Turkey.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Answers to frequently asked questions on Approved Document B including 2020 and 2022 amendments.
What to do if you think you've spotted a scam pretending to be from Companies House, and examples of scam emails, letters and telephone calls.
Pharmacovigilance system requirements
Documents, certificates, letters and notes available at the British Embassy and Consulates in China.
Documents you need when you get asked for a criminal record check when applying for a role
Environmental regulations and guidance on offshore oil and gas exploration and production, offshore gas unloading and storage and offshore carbon dioxide storage activities
Get a goods movement reference to move goods through locations which use the Goods Vehicle Movement Service.
A fully searchable PDF of all the Approved Documents.
Explainer on product information templates to be used by applicants and Marketing Authorisation Holders (MAHs) of veterinary medicines.
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