- 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.