Pharmacovigilance includes:

  • Adverse drug reactions
  • Interactions with other medicinal products
  • New effects of a medicinal product
  • Lack of efficacy of medicinal product
  • Misuse
  • Dependence, abuse

Pharmacovigilance takes place both at national and international level. The Norwegian Medicines Agency is actively contributing to the European Medicines Agency's Committee for pharmacovigilance, Pharmacovigilance Risk Assessment Committee (PRAC).

Pharmacovigilance Risk Assessment Committee (PRAC)

PRAC is the committee at the European Medicines Agency that is responsible for assessing and monitoring safety issues for human medicines..

The Committee consists of:

  • nominated members from all EU countries, plus Norway and Iceland
  • six independent scientific experts appointed by the European Commission
  • representatives of health professionals and patient organizations

The PRAC agenda and minutes are published on the EMA website.

Spontaneous reporting and signal detection

Spontaneous reporting is the core data-generating system of international pharmacovigilance, relying on healthcare professionals and consumers to identify and report suspected adverse drug reaction.

The spontaneous reports are used for detection of signals of a possible causal relationship between an adverse event and a drug. Using epidemiological and statistical methods, these signals are further evaluated and tested.

The Marketing Authorization Holder (MAH) has the primary responsibility for monitoring

The Norwegian Medicines Agency is responsible for the detection and monitoring of adverse reactions of all medicinal products approved in Norway, but it is still the pharmaceutical company that markets the individual medicine in Norway (MAH) that has primary responsibility for the effect and safety of their medicinal products.

The MAH must ensure that it has an appropriate system of pharmacovigilance and risk management in place in order to assume responsibility and liability for their products on the Norwegian market and to ensure that appropriate action may be taken when necessary. In order to fulfil the requirements, the MAH must ensure that all information relevant to the risk- benefit balance of medicinal products is reported to the authorities periodically through Periodic Safety Update Reports (PSUR) and continuously through expedited reporting of Individual Case Safety Reports (ICSR).

Publisert: 27.06.2016