Educational programmes are additional risk minimisation measures (RMM) (see GVP Module XVI) and usually require educational materials based on targeted communication with the aim to supplement the information in the summary product characteristics (SmPC) and package leaflet (PL).


When the development and distribution of educational material is recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) and endorsed by the Committee for Medicinal Products for Human Use (CHMP) and are included as a requirement in the marketing authorisation granted by the European Commission for the medicinal product in question, as applicable, key elements may be agreed at EU level. In this case, draft educational materials should be submitted to the competent authorities of Member States and these educational materials shall implement the key elements. Alternatively, the exact content of educational materials could be agreed at EU level and also become part of the summary of product characteristics (SmPC) and/or the package leaflet (PL), as applicable.


This Addendum to GVP Module XVI provides guidance for marketing authorisation holders on the submission of draft education materials to the competent authorities of Member States as well as guidance for these competent authorities on the assessment of such materials, in particular as regards the format and content. Individual Member States may have additional requirements, and as such this guidance should be followed together with other national guidelines.


This Addendum is applicable to both centrally and nationally authorised products, including those authorised through the mutual recognition and decentralised procedures.  



Posted on the EMA website on 27 April 2015