General questions
When will the law come into force in Norway / EEA?
The new legislation was implemented in Norwegian law 21 November 2013.
The implementation has lead to changes to the Regulation on medicinal products (Forskrift om legemidler).
Are there any additional national requirements?
The Norwegian Medicines Agency (NoMA) has not introduced any separate or additional Norwegian requirements. In particular, the MAH is not required to have a qualified person for pharmacovigilance (QPPV) residing in Norway.
Where should we send our questions about national issues related to legislation?
Question regarding the new legislation can be sent to adr@noma.no
We will not give individual responses to submitted questions, but this question and answer document will be updated as required.
Module I Pharmacovigilance Quality Systems
Currently, no questions asked
Module II Pharmacovigilance System Master File (PSMF)
How are MAHs expected to update PSMF?
PSMF will be continually updated as the various parts that make up the master file is updated. For example when the Risk Management Plan (RMP) is updated, when submitting a new PSUR, when the SPC and package leaflet is updated or when updating information on the QPPV etc.
Are there any national requirements for the PSMF?
No, there are no specific requirements for the Norwegian PSMF.
Module V Risk Management Plans (RMP) Module V Risk Management Plans (RMP)
Where will the Summaries of the RMPs be published?
Summaries of the RMPs will be published on the EU web portal that EMA is responsible for. NoMA will have a general link to the appropriate page on the EU web portal.
Will education material, required in the RMP, be published in Norwegian on the Norwegian Medicines Agency's website?
Educational material, required in the RMP, will not be published on the Norwegian Medicines Agency website. However, the Norwegian Medicines Agency encourages the marketing authorization holders to publish the material on Felleskatalogen.no. Most MAH follow this encouragement. This type of educational material must be available in Norwegian, but exemption may be granted, for example if the target group is very limited. The MAH shall distribute the material electronically or on paper upon request.
Module VI Management and reporting of adverse reactions to medicinal products
What reporting requirements apply in Norway?
In the following, we make no distinction between the adverse drug reactions (ADRs) reported by patients and ADRs reported by health care professionals.
From November 2017, the MAH shall report all ADRs to EudraVigilance (EV) and not to NoMA.
For adverse events occurring in Norway:
- Serious ADRs: MAH sends the ICSR to EudraVigilance within 15 days.
- Non-serious ADRs: MAH sends the ICSRs to EudraVigilance within 90 days.
ADRs occuring in other EU countries or outside the EU/EEA are to be reported to EudraVigilance.
Which ICSRs will NoMA send to the MAHs?
NoMA will no longer send ICSRs to the MAHs. NoMA forwards all serious and non-serious ICSRs to EudraVigilance, where they will be made available for downloading by the MAH. This includes ICSRs from both patients and health care professionals.
NoMA will transmit all serious, Norwegian ICSRs (from patients, health care professionals and MAHs) to EudraVigilance (EV). Non-serious ICSRs will not be transmitted to EV in the transitional period / until further notice.
Which requirements apply to the MAH's monitoring of the Internet pages in Norway?
Please refer to the guidance in the final version of GVP Module VI.
The applicant/MAH must monitor ICT data sources under the management/responsibility of the applicant/MAH, this includes sponsored webpages.
For external data sources not under the management/responsibilty of the applicant/MAH, there is no requirement to monitor the data source, but the applicant/MAH are encouraged to establish an analysis plan describing how they will review and analyse the dataset, including how adverse events they identify are assessed and reviewed for requirements to report.
Is there a list of local journals that should be monitored by MAH in order to ensure compliance with the requirements for literature surveillance?
No
Which requirements apply to the MAH’'s adverse reactionreporting in organized data collection (non-interventional studies, etc.)?
Please refer to the guidance in the final version of GVP Module VI.
Modul VII Periodic Safety Update Reports (PSUR) Module VII Periodic Safety Update Reports (PSUR)
"Effectiveness" data versus efficacy data - how to obtain the "effectiveness" data?
Effectiveness will reflect the effects in normal clinical practice as opposed to efficacy which is data documented in clinical trials. Effectiveness must be documented through post-marketing studies - known as Post-Authorisation Safety Studies (PASS) or Post-Authorisation Efficacy Studies (PAES). This is described in more detail in Module V Risk Managment Plans part V.B.9.2 and in Module VIII Post-Authorisation Safety Studies. A separate module for PAES is under development.
When will the PSUR repository be ready for use?
The development of a PSUR repository depends on EMA's capacity to develop the necessary ICT tools. There is no set date by which this will be completed. EMA will publish information on their website when a repository is in place.
How is the MAH informed of changes in the Union Reference Date list (URD list)?
Frequent update of the URD list is expected in the initial phase, and EMA has indicated that there will be monthly update published on the EU web portal. MAHs are obliged to make themselves familiar with these updates.
How to get new sections into the PSUR document if the old PSUR format is used in the transitional phase?
MAHs can in the transition phase (until January 2013) choose to submit a PSUR in the old format (according to Vol 9A) or in the new format. If a MAH chooses to use the old format, line listings must be included and, in addition, the MAH must include a critical evaluation of the benefit-risk ratio.
Module VIII Post-Authorisation Safety Studies (PASS)
Will NoMA require PASS protocols and "progress reports"?
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)
See also GVP Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev 3).
