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Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Structuring, designing and publishing your API documentation
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Processes and principles used by the UK National Screening Committee (UK NSC)
Explains how conditions attached to a planning permission should be used and discharged effectively
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product licence submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect...
The characteristics, diagnosis, management, surveillance and epidemiology of Shiga toxin-producing Escherichia coli (STEC).
Form (S10) for requesting hepatitis B virus (HBV) sequencing by the Blood borne viruses unit (BBVU) .
How to carry out a flood risk assessment so that you can complete your planning application
Genome sequencing, transcription and proteogenome analysis, pathogen discovery and metagenomics.
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