On 27 April 2015, the European Medicines Agency (“EMA”) launched a public consultation on its Good Pharmocoviligance Practices (“GVP”) concerning educational materials. The draft guidelines are contained in GVP Module XVI Addendum 1.
In accordance with GVP Module V on risk management systems, it is recalled that the marketing authorisation applicant/holder should provide details on the risk minimisation measures that should be taken in order to mitigate the safety concerns of the medicinal product. Additional measures should also be introduced when deemed necessary for the safety of the medicinal product. Educational material should be submitted to the competent authority of the EU Member State following the conclusion of the regulatory procedure in which approval of the risk minimisation measures has been attained.
GVP Module XVI Addendum 1 will provide guidance for the marketing authorisation holder/applicant on the submission of draft educational materials to the competent authority of the EU Member State. In addition, GVP Module XVI Addendum 1 will also offer advice for the relevant competent authority concerning the assessment of the educational materials.
The draft guidelines are intended to support the preparation of educational materials required as part of risk minimisation measures for authorized medicinal products. The objectives outlined within educational materials should expand on the information provided in the summary of product characteristics (SmPC) and the package leaflet (PL).The draft guidelines advise that information provided in educational materials should inform the actions of healthcare professionals to ensure the safety and efficacy of the concerned medicinal product. Information should be clearly distinguished from promotional material and interpreted as separate material that is specifically developed for risk minimisation purposes.
Format and Content
The draft guidelines remind marketing authorisation holders that the scope of the content provided should be in conformity with the “key elements”, which are referred to in Article 9(4) of Regulation (EC) No 726/2004 and Article 21a(a) of Directive 2001/83(EC). They define the format and content that draft educational materials should follow. It provides guidance on format, and on the procedural steps concerning submission of educational materials.
Stakeholders may submit comments on the draft guidelines until 30 June 2015. The date of effect for the implementation of the final version of GVP Module XVI Addendum 1 is anticipated for the final quarter of 2015.