​​​​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 possibly be published at the EU web portal in the future, or made available upon request from the EMA. The educational material is usually also available in Norwegian, but will normally not be published by NoMA . The educational material will be available 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 reactions (ADRs) reported by patients and ADRs reported by health care professionals. These reporting requirements apply during the transitional period from July 2012 until EMA declares that the new EudraVigilance (EV) functionality is available and the transitional period is over.

For adverse events occurring in Norway:

  • Serious ADRs: MAH sends the ICSR to NoMA within 15 days.
  • Non-serious ADRs: MAH is not required to send non-serious ICSRs in the transitional period.

Non-serious ADRs are to be included in the MAH’s continuing risk benefit assessment, and the MAH shall notify NoMA if the risk-benefit balance is altered. MAH should be able to send non-serious ADRs upon request.

For ADRs occurring outside the EU / EEA:

  • Serious ADRs: MAH sends the ICSRs to EudraVigilance within 15 days
  • Non- serious ADRs: MAH has no obligations.

Which ICSRs will NoMA send to the MAHs? 

NoMA will forward all serious ICSRs (anonymously) to MAHs within 15 days. This includes ICSRs from both patients and health care professionals. In addition, NoMA will continue to send line listings biannually.

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.

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), and,
  • for which Norway is concerned member state (CMS) or Member State (MS), only if the study/part of the study is taking place in Norway."

 

See also GVP Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev 2).

Oppdatert: 01.12.2017

Publisert: 27.06.2016

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