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PSMF establishment and maintenance, business as usual?

News   •   May 31, 2013 09:00 CEST

Since the implementation of Directive 2010/84 and Regulation 1235/2010, marketing authorisation holders (MAHs) with products on the European market are obliged to maintain, and make available upon request, a Pharmacovigilance System Master File (PSMF).

The PSMF comprises a range of annexes supported by a main document that, in its entirety, encapsulates the respective MAHs approach to continuous monitoring of a given product’s risk-benefit balance.

But how do companies ensure that the PSMF and corresponding annexes are updated and successfully reflect the company’s pharmacovigilance system? And how do you as an organisation successfully implement and maintain a PSMF without the need for additional resources?


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