Preparation and distribution of educational material
The obligation imposed on marketing authorisation holders to prepare and disseminate educational materials is described in the applicable law and guidelines in the area.
The content of the educational material will often appear from the risk management plan in the form of key elements that must be addressed in the educational material. In some cases, a full text in English may have been approved for the educational material in the risk management plan.
As regards educational material for dissemination in Denmark, the marketing authorisation holder must submit the following to the Danish Medicines Agency:
- Proposal for educational material in Danish in Word
- The approved key elements in English/the approved text in English
- Proposal for distribution list
- Proposal for distribution path(s)
- Timetable for the distribution of educational material
The material must be submitted to the Danish Medicines Agency before the medicine is marketed on the Danish market. It must be submitted in a separate email to the licensing mailbox. In the subject field, please write ”EDUMAT”.
The marketing authorisation holder must await the Danish Medicines Agency’s assessment before distributing the educational material. We aim to complete the assessment of the educational material no later than 60 days after we received all of the above documents.
The marketing authorisation holder must send the final educational material, adjusted according to our assessment, to the relevant specialists on the agreed distribution list within the agreed time frame. The final educational material should always be sent to the Danish Medicines Agency by email.
In case the same requirement for educational material is set under different procedures, we encourage the marketing authorisation holders to collaborate on the preparation of the educational material. The marketing authorisation holders should submit only one proposal for the educational material to the Danish Medicines Agency. We also recommend that the marketing authorisation holders collaborate on the dissemination of the educational material to make sure that the recipients on the distribution list receive the same common educational material.
We reserve the right to return the proposal for the educational material to marketing authorisation holders if the translation is not of a good quality and has many errors and misunderstandings.
If you have any questions as to the procedure, please write to us at the licensing mailbox