No national requirements to the pharmacovigilance legislation
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)
NoMA will request protocols, progress reports and final reports from studies the MAH is obliged to perform in accordance with Regulation 726/2004 article 10 a (1)(a) and Directive 2001/83/EU art 21a (b) and 22 a (1), on products:
- for which Norway is the Rapporteur or Co-rapporteur in the centralized procedure,
- for which Norway is the reference member state (RMS) in the mutual recognition procedure (MRP) or decentralized procedure (DCP),
- for which Norway is the Lead Member State for the PSUR Single Assessment (PSUSA),
- approved by the national procedure (NP)