Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum I – Educational materials:
Addendum I.1. Introduction:
Educational programmes are additional risk minimisation measures (aRMM) (see GVP Module XVI) and usually include educational material(s) aimed to minimise an important risk and/or to maximise the risk-benefit balance of a medicinal product. The content of any educational material should be fully aligned with the currently authorised product information for the medicinal product, i.e. the summary product characteristics (SmPC), the package leaflet (PL) and the labelling, and should add rather than replicate SmPC and PL information.
When the development and distribution of educational material is recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) and endorsed by the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh), key elements of any educational material are agreed at EU level. Thereafter, drafts of the educational material(s) addressing the key elements should be submitted by the marketing authorisation holder to the competent authorities of Member States for assessment and then be implemented in Member States upon approval by the competent authorities.
Guidance on the requirements for including the key elements of the educational material(s) and/or the educational material(s) addressing the key elements as distributed in the Member States in an annex to the risk management plan (RMP) is provided in GVP Module V.
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EMA GVP Module 16, Addendum I:
