Consultation document. Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework. Draft.

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Publication Date 09/09/2004
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The European Medicines Agency (EMEA), on 9 September 2004, launched a consultation exercise on proposals aimed at putting in place a transparent process for the development, consultation, finalisation and implementation of pharmaceutical guidelines. Pharmaceutical guidelines provide essential information to be taken into account in the research and development of new medicines. They are a key part of the Agency's work within the European Union pharmaceutical regulatory system. The proposed improvements to the current guideline procedures also form part of the Agency's response to a transparency consultation exercise carried out in 2003. Deadline for responses: 8 December 2004.
Source Link http://www.emea.europa.eu/pdfs/human/regaffair/2414304en.pdf
Related Links
European Medicines Agency: New EMEA transparency policy measures, 2003 http://www.emea.europa.eu/pdfs/general/manage/mbar/Transparancy%20pol/005203en.pdf
European Medicines Agency: Press Release: EMEA/62818/2004 (9.9.04) http://www.emea.europa.eu/pdfs/general/direct/pr/6281804en.pdf
European Medicines Agency: Press Release: EMEA/62818/2004 (9.9.04) http://www.emea.europa.eu/htms/hotpress/d6281804.htm
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