Educational materials for medicinal products

Updated 06 April 2017

Educational materials must supplement the information provided in the summary of product characteristics and the package leaflet.

During a regulatory procedure, the authorities may demand that educational material should be prepared. Usually, the requirement for educational material will appear from the approved risk management plan in the form of key elements that must be addressed in the educational material.

The content of the educational material and the list of recipients must be prepared by the marketing authorisation holder and submitted to the Danish Medicines Agency for assessment.

Subsequently, the marketing authorisation holder should send the educational material directly to the relevant specialists.

For more information, see Preparation and distribution of educational material.

Click this link to find educational material in Danish prepared in connection with national, MRP and DCP procedures.

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