PSMF establishment and maintenance, business as usual?

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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).
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Contacts

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

Related content

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).