Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
For all UK MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the marketing authorisation holder must have permanently and continuously at its disposal a QPPV who resides and operates anywhere in the UK or in the EU/EEA, and is responsible for the establishment and maintenance of the pharmacovigilance system.
Read the press release story from Medicines and Healthcare products Regulatory Agency published on 17 November 2023.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (12 février 2024). Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF). ELSIBI. Consulté le 18 février 2025 à l’adresse https://doi.org/10.58079/vto0