The PSMF must be located either at the site in the European Union where the main pharmacovigilance activities of the marketing authorization holder are performed or at the site in the Union where the QPPV operates.
Following European Economic Area (EEA) agreements, the QPPV may also reside and operate in Norway, Iceland or Liechtenstein.
The MAH may subcontract certain activities of the pharmacovigilance system to third parties. It shall nevertheless retain full responsibility for the completeness and accuracy of the pharmacovigilance system master file (PSMF).
Yes: Multiple MAH can share a common PSMF
Can the server of the Pharmacovigilance System Master File (PSMF) be physically located and administered outside EU if it is validated and operational/accessible 24/7 for EU markets and EU QPPV?
According to Article 5(3) of Commission Implementing Regulation (EU) No 520/2012, the pharmacovigilance system master file may be stored in electronic form provided that the media used for storage remain readable over time and a clearly arranged printed copy can be made available for audits and inspections.
In addition, Article 7 of Commission Implementing Regulation (EU) No 520/2012 clarifies that:
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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.
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The marketing authorisation holder shall ensure that the qualified person for pharmacovigilance has permanent access to the pharmacovigilance system master file.
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The pharmacovigilance system master file shall be permanently and immediately available for inspection at the site where it is kept.
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Where the pharmacovigilance system master file is kept in electronic form in accordance with Article 5(3), it is sufficient for the purposes of this Article that the data stored in electronic form is directly available at the site where the pharmacovigilance system master file is kept.
The MAH will have to draw up a list of its existing subcontracts between himself and the third parties, specifying the product(s) and territory(ies) concerned.
When delegating any activities concerning the pharmacovigilance system and its master file, the MAH retains ultimate responsibility for the pharmacovigilance system, submission of information about the PSMF location, maintenance of the PSMF and its provision to competent authorities upon request. Detailed written agreements describing the roles and responsibilities for PSMF content, submissions and management, as well as to govern the conduct of pharmacovigilance in accordance with the legal requirements, should be in place.