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.
Further information on educational material can be found on the website of the Federal Institute for Drugs and Medical Devices (BfArM) and the Federal Paul-Ehrlich-Institut (PEI).
List of the active substances or trademarks for which educational material has been required can be found at:
List of BfArM-educational material and List of PEI-education material
Without prejudice to the originality of the format of the educational material, it is in the interest of public health that educational material used by different applicants/marketing authorisation holders for the same active substance should be kept as similar as possible, in order to deliver a consistent message and avoid confusion in the target audience (see also GVP Module XVI Addendum I, EMA-Good Pharmacovigilance Practices). In addition, educational material may be changed or supplemented by the original marketing authorisation holder. To ensure that only the latest version is used, we refer to the educational material of the original marketing authorisation holder.
Approved educational material can be found at:
If no educational material for an affected drug is available in the listed links, we recommend that you directly contact the original marketing authorisation holder. The respective materials and/or information in the latest version are available on the website of the original pharmaceutical company or on the respective product website.
If you need any further help, we are happy to assist you by our service telephone number +49 (2159) 91 44 70 or send us your inquiry by e-mail.