Medicinal products with educational material (EDUMAT)
Educational material is a type of additional risk minimisation measures (see GVP modul XVI). The purpose of educational material is to minimise important risks and/or maximise the benefit/risk ratio of a medicinal product.
The content of any educational material should be fully consistent with the currently approved product information for the medicinal product - and it should add rather than repeat information already mentioned in the Summary of Product Characteristics and the Package Leaflet.
In the course of a regulatory procedure, the authorities may require the preparation of an educational material as specified in the approved risk management plan (RMP).
Please refer to the section Preparation and distribution of Danish educational material for further information.
Please refer to the section Dansk uddannelsesmateriale for the accepted and published Danish educational material for medicinal products authorised via:
- National procedure
- Mutual recognition procedure (MRP)
- Decentralised procedure (DCP)
- Centralised procedure (CP)
Please refer to the section Parallel distributionfor further information regarding parallel distribution of centrally authorised medicinal products with additional risk minimisation measures.