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How to get access to MHRA submissions portals, how to use them, where to go for help.
How to apply for a full or partial completion certificate after building work on a higher-risk building has been completed.
Guidance on the deadlines for initial and response submissions.
How to submit a proposal to UKDI
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to submit an application, data package and responses for proposed or existing marketing authorisations.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Instructions on how members of the public can submit their submissions to support the work of the team of experts leading the review.
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