XVI. Add I.2. Principles for educational materials

The following principles apply to educational materials:

• The need for educational materials will be agreed during a regulatory procedure, at the moment of the initial marketing authorisation or in the post-authorisation phase.
• Any educational material should focus on the risk minimisation objectives.
• It should focus on the specific safety concerns and provide clear statements and concise messages describing actions to be taken in order to prevent and minimise these risks.
• It should not be combined with promotional materials for the marketing of the medicinal product. 38 Educational materials should be drafted in the official language(s) as required by the Member State.
• The competent authority(ies) of the Member State(s) where the medicinal product is/will be marketed should review the national version of the educational material. Agreement should be reached before it is disseminated by the marketing authorisation holder at national level.
• The national version of the educational material should only be submitted to the competent authorities of Member State following conclusion of the regulatory procedure in which the risk minimisation measure (RMM) was agreed, i.e. a CHMP opinion or CMD(h) position based on a PRAC recommendation, a Commission Decision or a notification of approval of a variation of the marketing authorisation or the risk management plan (RMP).
• When the need for educational material is agreed at EU level (i.e. the European Commission or the competent authority(ies) of (the) Member State(s), depending on the regulatory procedure), the dissemination of the educational material is mandatory. The modalities for dissemination and the target audience are determined by the competent authority(ies) of (the) Member State(s).
• The marketing authorisation holder should provide a proposal of the target population of the material.
• The marketing authorisation holder should exercise version control and ensure that it disseminates only the latest agreed version of the educational material.