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PSMF establishment and maintenance, business as usual?

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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Tina Joanne Hindsbo

Tina Joanne Hindsbo

Press contact Head of Public & Media Relations +45 3077 9578
Sofie Mand Steffens

Sofie Mand Steffens

Press contact Senior Communications Consultant +45 3077 8337

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