XVI. Add I.5. Content of educational materials

The reference documents to be used in the preparation of educational materials are the agreed risk management plan (RMP) (including its annexes), product information (SmPC and PL) and the 110 conditions of the marketing authorisation, the so-called Annex IIB for centrally authorised products and Annex III for nationally authorised products included in a referral or a single PSUR assessment procedure.

The educational material should contain the key elements as agreed at EU level in the corresponding conditions of the marketing authorisation (as referred to in Article 9(4) of Regulation (EC) No 726/2004 and Article 21a(a) of Directive 2001/83/EC) in an appropriate format and layout. The SmPC and/or PL may be attached to the educational material and disseminated together; or the educational material may contain a reference to the website of the competent authority of the Member State or the Agency when SmPC and/or PL are made publicly available on these websites. References to other websites for “more information” will usually not be accepted unless it refers to the SmPC/PL.

In order to avoid repetition of SmPC and/or PL texts, the messages in the educational material should 121 complement the SmPC and/or PL based on the agreed key elements with important data to support the 122 implementation and hence effectiveness of the RMM.

Images and graphic presentations of the information should only be used when text alone is insufficient to adequately convey the key element(s) and should not be promotional.

The scope of the information in the educational material should be limited to the key elements agreed at EU level. Additional information such as efficacy data, comparisons of safety with other medicinal products or statements which imply that the medicine is well tolerated or that adverse reactions occur with a low frequency should not be included. Referring to other medicinal products outside the scope of the educational material is not allowed.

A statement encouraging the reporting of any suspected adverse reaction and the modalities to report in the competent authority of the Member State should be included.