Educational material as a condition of the marketing authorisation

Educational programs are additional risk minimisation measures (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.

 Guideline on good pharmacovigilance practices module XVI

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 Medical Products Agency (MPA). The material needs to be examined and get a statement from the MPA before the educational material can be used in Sweden and before the product is placed on the market.

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 is provided in GVP Module V.

  Guideline on good pharmacovigilance practices module V

Addendum I to GVP Module XVI provides further guidance for marketing authorisation holders on the submission of draft educational material(s) to the competent authorities. Because of the specificities of the national healthcare systems and of how particular risk(s) are managed within these systems, individual Member States may have additional requirements. In this case, the guidance in the Addendum should be followed together with national guidelines.

 Guideline on good pharmacovigilance practices module XVI Addenum I

 
 
 

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