II.C.2. Accessibility of the pharmacovigilance system master file

The PSMF shall be kept up to date and be permanently available to the QPPV [IR Art 4(1) and Art 7(2)]. It shall also be permanently available for inspection, at the site where it is kept [IR Art 7(3)] (the stated location), irrespective of whether the inspection has been notified in advance or is unannounced.

According to Article 104(3)(b) of Directive 2001/83/EC the marketing authorisation holder shall maintain and make available on request a copy of the PSMF. The marketing authorisation holder must submit the copy 7 days at the latest after receipt of the request from a national competent authority or the Agency. The PSMF should be submitted in a readable electronic format or clearly arranged printed copy.

In the situation where the same PSMF is used by more than one marketing authorisation holder (where a common pharmacovigilance system is used) the concerned PSMF should be accessible to each, as any of the applicable marketing authorisation holders shall be able to provide the file to the competent authorities within 7 days, upon request [DIR Art 23(4), IR Art 7(4)].

The PSMF should not routinely be requested during the assessment of new marketing authorisation applications (i.e. pre-authorisation), but may be requested on an ad hoc basis, particularly if a new pharmacovigilance system is being implemented, or if product specific safety concerns or issues with compliance with pharmacovigilance requirements have been identified.