European Medicines Agency phasing out follow-up measures

News 01/08/2012

The European Medicines Agency reminds marketing-authorisation holders that it is phasing out follow-up measures to marketing authorisations.

In the context of an exercise on quality of opinions started together with the European Commission, the Agency and its Committee for Medicinal Products for Human Use (CHMP) have started to classify all post-authorisation measures for human medicines as one of the following:

  • conditions in Annex II (obligations or specific obligations to fulfil post-authorisation measures);
  • additional pharmacovigilance activities in the risk-management plan;
  • recommendations for further development.

This new system of classification is being phased in a stepwise manner. The first phase tackled initial marketing-authorisation-application opinions as of June 2011, followed by post-authorisation procedures starting in November 2011.

Starting this month, the Agency and the CHMP are now reclassifying all outstanding unclassified follow-up measures.

Follow-up measures were measures applied to marketing authorisations, setting out studies and other activities that the Agency and CHMP had asked the marketing-authorisation holder to perform.

Marketing-authorisation holders affected by these changes will receive an outcome fax for each of their products as applicable. These faxes will include information about the new classification of their follow-up measures, together with any actions that they need to take.

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