Package Leaflet Information
This article was originally published in SRA
Executive Summary
European Commission releases guideline on consultations with patient groups
European Commission releases guideline on consultations with patient groups
The European Commission has published a guidance document recommending user testing as the best method to assess if a package leaflet is understandable and user friendly. In accordance with Articles 59(3) and 61(1) of Directive 2001/83/EC as amended, package leaflets must reflect the results of consultations with target patient groups.
User testing is a means to identify if the information provided on the package leaflet adequately conveys the correct messages to those who use the product, and any areas that need clarification should be easily identifiable during the process1. It should be part of module 1 of the application dossier. Other testing methods may be permissible by the commission but will have to be justified by the applicant and will be assessed on a case-by-case basis.
In general, the conduct of user tests will be essential prior to the granting or varying of any marketing authorisation under the centralised, decentralised, mutual recognition or national procedures. However, in some circumstances it will be possible for the applicant to refer to evidence from tests on similar package leaflets. For example, this may be possible when the application is for extensions for the same route of administration or has the same safety issues as the referred to product leaflet. Sound justification for this method would have to be provided by the applicant.
European legislation requires that the package leaflet has to be legible in all the languages of the European Economic Area, although patient consultation need only be undertaken in one language. Results should be presented in English for applications through the centralised, decentralised and mutual recognition procedures. The translation of the leaflet into other languages following the granting of a marketing authorisation is the responsibility of the licence holder in consultation with the member states or the European Medicines Agency.
References
1. European Commission - Guidance concerning consultations with target patient groups for the packaging leaflet, 22 May 2006, http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/user_consultation_200605.pdf