Isabella Barbieri -

Before the launch, any educational materials provided for in the Risk Management Plan of a centrally approved medicinal product shall be implemented according to the European Commission (EC) decision.
The medicinal product cannot be marketed in Italy before the Italian version of the educational materials are approved by the Pharmacovigilance Office of the Italian Medicines Agency (AIFA).
The Marketing Authorisation Holder is also requested to submit a proposal for the distribution plan (target for the distribution and dissemination procedure) that will be evaluated during the approval procedure.

The educational materials could be available in multiple formats (paper, audio, video, web, training) but the publication of the materials on the website should not be the only method of information dissemination. The access to the safety information should be guaranteed also in case of lack of internet access.

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