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No national requirements to the pharmacovigilance legislation

Published:

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Updated:

Changes

  • : Removal of additional national requirements for PASS

​​​There are no separate or additional Norwegian requirements to the pharmacovigilance legislation.

In particular, the MAH is not required to have a qualified person for pharmacovigilance (QPPV) residing in Norway. Neither are there any specific Norwegian requirements for the Pharmacovigilance System Master File (PSMF).

Post-authorisation safety studies (PASS)

The regulations for PASS are described in GVP module VIII and in its Addendum I. There are no additional national requirements. In particular, there is no requirement to submit a “progress report” for PASS of categories 1 and 2.

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