XVI. Add I.3. Submission of educational materials

The draft educational material should be submitted to the competent authority(ies) of (the) Member State(s) as follows:

• with a submission cover letter including information on:
  • the contact point of the marketing authorisation holder and, if applicable, another organisation to which it has subcontracted the submission (at least names and e-mail addresses);
  • the route of authorisation;
  • the origin of the request with supportive documents (e.g. CHMP opinion, CMD(h) position and/or Commission Decision including conditions of the marketing authorisation and other annexes, approved RMP, assessment report identifying the need for this RMM);
  • detailed implementation plan for the educational material:
  • target populations;
  • dissemination method;
  • intended dissemination time;
  • estimated date of launch of the product (in the case of a new marketing authorisation).
• as documents in a common open text-processing electronic format of the proposed materials in language(s) required by the Member State(s);
• the intended lay-out and, where applicable, images and graphic presentations of the information (e.g. pictures, charts, diagrams, video).

If the submission concerns an update of educational material previously agreed with a competent authority of a Member State, the changes to the agreed material should be highlighted.