XVI. Add I.4. Format of educational materials

The format of educational material should include the following:

• invented name of the medicinal product followed by the active substance(s) and/or therapeutic class in brackets. However, the invented name should only appear where strictly necessary and the number of times the invented names appears in the educational material should be limited. If there is educational material applicable to several products from different marketing authorisation holders, the educational material should refer to the active substance only and a list of the invented names in the Member State should be annexed;
• if necessary, mention of the different presentations of the product, e.g. the different pharmaceutical forms, the strengths, the routes of administration;
• the title line “Important Risk Minimisation Information for ” to clarify the purpose of the educational material;
• an additional title line identifying the type of educational material, e.g. administration guide, checklist for prescribing, alert card, educational leaflet for the patient;
• thereafter a statement explaining that the educational material is essential to ensure the safe and effective use of the product and appropriate management of the important selected risks and therefore it is advised to be read carefully before prescribing/dispensing/administering the product;
• if the medicinal product is under additional monitoring (see Module X), the black symbol should be included next to the medicinal product name or active substance name, along with the explanatory 96 standard statement for additional monitoring;
• bullet points should be used wherever appropriate to present the information clearly;
• materials should be kept as brief as possible, however, if the educational material is long, an introductory text summarising the key messages should be added and an index may be included;
• for version control, the version number and the date of agreement of the material by the competent authority(ies) of Member State(s) in the format of “ ” on each sheet of the educational material, unless the type of educational material requires an appropriate exceptions (e.g. a video should have this information appearing at its beginning and end).

If the logo of the marketing authorisation holder appears, the logo should appear only once in each educational material, preferably on the last page. If it however appears on the first page, the logo should not be larger than the document title. No product logos or slogans should be used.