Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework

This paper describes the different types of guidelines that can be considered to form part of the European pharmaceutical legislative framework and explains how these fit into the annual work programmes of the European Medicines Agency (EMEA). It outlines a transparent procedure for the development, consultation, finalisation and implementation of guidelines. It also updates and replaces previously published and draft guidance in this area, in particular the European Commission paper on 'Procedure for European Union guidelines'.