Educational Materials: Review of National Regulatory Requirements in the EU/EEA

Educational Material is a type of additional Risk Minimisation Measure (aRMM) in pharmacovigilance. The requirements for these aRMMs are given during the marketing authorisation application process. The requirements for medicinal products subject to the EU Centralized Procedure are provided in Annex II of the Commission Implementing Decision. For other procedures (National or Decentralised Procedures), they are described in the Risk Management Plan (RMP) of a medicinal product.

As laid out in Good Pharmacovigilance Practice (GVP) module XVI Addendum I, Marketing Authorisation Holders (MAHs) responsible for products requiring aRMMs in the form of educational materials are required to submit these materials to the National Competent Authority (NCA) for assessment and approval before launching their products on each market.

It is essential to consider that, in addition to the GVP, each EAA/EU member state has country-specific requirements for the educational materials that the MAH must comply with. Unfortunately, these are most often available only in national languages and hidden somewhere in the NCAs website or its legislation archives. Therefore, it may be particularly challenging to handle the local implementation of Educational Materials, in case you do not have local internal structures or service providers who could help.

To help MAHs cope with this, the Insuvia team has developed a comprehensive guidance document on country-specific requirements for Educational Materials implementation in the EEA/EU member states. Our guidance document captures the key local requirements and country differences, including:

• Timelines for local approval of Educational Materials
• State fees applicable for Educational Materials review by the NCAs
• Submission routes of Educational Materials to the NCAs
• Branding possibilities on Educational Materials and applicable requirements
• Languages in which Educational Material should be made available
• Final mock-ups approval requirement prior dissemination

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