The European Medicines Agency and its Committee for Medicinal Products for Human Use (CHMP) have started to classify all post-authorization measures for human medicines as it phases out follow-up measures to marketing authorizations. The new classification system is being phased in a stepwise manner. Post-authorization measures will be classified as either: conditions in Annex II (obligations or specific obligations to fulfill post-authorization measures); additional pharmacovigilance activities in the risk-management plan; or recommendations for further development.
EMA and CHMP are reclassifying all outstanding unclassified follow-up measures, starting in August 2012. The first phase of the new classification system tackled initial marketing-authorization-application opinions as of June 2011, followed by post-authorization procedures starting in November 2011.
According to EMA, “Follow-up measures were measures applied to marketing authorizations, setting out studies and other activities that the Agency and CHMP had asked the marketing-authorization holder to perform.” Affected marketing-authorization holders will receive an outcome fax that includes information about the new classification for each of their applicable products.