The State Agency of Medicines would like to draw your attention to the following requirements regarding the Qualified person responsible for pharmacovigilance (QPPV) and Pharmacovigilance system master file (PSMF) related to BREXIT.
- In accordance with Sub-paragraph 15.3 of the Cabinet of Ministers Regulation No. 47 adopted on 22 January 2013 “Pharmacovigilance Procedures” it is the responsibility of the marketing authorisation holder to “have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance (hereinafter – the responsible person) who is living and working in the European Union and is responsible for the establishment and maintenance of the pharmacovigilance system”.
- Information in accordance with Article 7(1) of the Commission Implementing Regulation (EU) No. 520/2012 regarding the availability and location of the pharmacovigilance system master file: “The pharmacovigilance system master file shall be located either at the site in the Union where the main pharmacovigilance activities of the marketing authorisation holder are performed or at the site in the Union where the qualified person responsible for pharmacovigilance operates.”