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

Author (Corporate)
Publisher
Publication Date 30/06/2005
Content Type

The purpose of this paper is to describe and define the different guidelines that support the European pharmaceutical legislative framework and to describe a harmonised procedure for their development. It explains how the guidelines fit into the annual work programmes of the European Medicines Agency (EMEA) and it outlines a transparent procedure for the development, consultation, finalisation and implementation of guidelines. It updates and replaces previously published and draft guidance in this area, in particular the European Commission paper on 'Procedure for European Union guidelines'.

Source Link Link to Main Source http://www.emea.europa.eu/pdfs/human/regaffair/2414304en.pdf
Related Links
European Medicines Agency: Press Release: EMEA/216832/2005 (30.6.05) http://www.emea.europa.eu/pdfs/general/direct/pr/21683205en.pdf

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