Skip to content Norwegian Medical Products Agency Norwegian Medical Products Agency

Pharmacovigilance legislation



Patient safety is significant both in regard to the approval of new medicinal products and follow-up of safety and effectiveness after marketing. There are strict requirements for how pharmaceutical companies should follow up on this.

Requirements for follow-up of medicinal products with regard to patient safety are described in the following legislation and guidelines:

New knowledge about a medicinal product is normally communicated to healthcare personnel and patients through updates to the product information and package leaflets. If it is particularly important to draw attention to new safety information, it may be relevant to ask the pharmaceutical company to send out a letter to healthcare personnel (Dear healthcare personnel letter), or to prepare educational material intended for healthcare personnel and/or patients.

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).

Change in QPPV

Changes in the qualified person responsible for pharmacovigilance (QPPV), including contact details shall be updated through the Article 57 database only, without the need to submit a type IAIN variation to the Agency or the national competent authority.

For back-up procedures, see GVP Module I.

Post-authorisation safety studies (PASS)

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

Contact us

Unit for better use of medicines

+47 22 89 77 00