Ed­u­ca­tion­al Ma­te­ri­al

Additional Risk Minimisation Measures and Educational Materials (if marketing in Germany is planned)

The Educational materials (as implementation of the requirements for additional risk minimisation measures in Germany) including the communication plan must be prepared and presented in the German language.

The examination and release is based exclusively on the German versions.

This linguistic specification does not apply to the underlying requirements such as Annex II/D of the drug approval, the extracts and annexes of the RMP, which will usefully be attached to the submission of the Educational materials.

Updated: 21.11.2019