Educational material is additional information which is relevant for the safe use of the medicinal product concerned and has to be made available for specific medicinal products in addition to the Summary of Product Characteristics and Package Leaflet. For centrally licensed medicinal products, and to a lesser extent for medicinal products having undergone other marketing authorisation procedures, such additional educational material could be a component of the Risk Management Plans (RMP) introduced in 2005. Providing educational material is an additional risk minimisation measure that exceeds mere awareness of the product information. In certain cases, the provision of such educational material is necessary from a regulatory point of view in order to reach a positive assessment of the benefit-risk ratio of these medicinal products.
The legal basis for imposing the condition that the MAH shall compile educational material is provided for centralised procedures in Article 21 of Regulation (EC) No 726/2004 in conjunction with Article 104 of Directive 2001/83/EC as amended and for national, decentralised or mutual recognition procedures in Section 63 b) as well as Section 28 sub-sections 3 a) and b) AMG.
Based on the EMA's list for centrally licensed medicinal products, the BfArM has compiled a corresponding table with the active substances that require provision of the described educational material. This list additionally contains those substances that underwent other licensing procedures and have also been licensed subject to the condition that the educational material is provided. The contents of this educational material have to be reviewed and approved by the BfArM. This list is updated at regular intervals.
Active substances and trademarks for which educational material is to be provided (available in German only)
For further information on submission and processing of educational material please refer to our announcement of 16 May 2013:
Announcement regarding the modalities of electronic initial or subsequent submissions as well as on the processing of educational material as part of a Risk Management Plan in accordance with Section° 4 sub-sections 36 and 37 of the German Medicinal Products Act (Arzneimittelgesetz, AMG) (available in German only)