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How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Information on good laboratory, manufacturing and distribution practice, good pharmacovigilance practice (GPvP), out-of-specification investigations, inspection metrics and fees.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Find out about the process and costs to apply for Defra disinfectant approval.
Check for listed disinfectants for aquaculture; or apply to have your product listed.
The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care .
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