General: Regulatory and procedural guidance
Table of contents
- Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
- Consolidated Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC, Directive 2003/63/EC, Directive 2004/24/EC, Directive 2004/27/EC and Directive 2008/29/EC
- Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
- 'Marketing Authorisation', the Rules governing Medicinal Products in the European Community, Notice to Applicants, Volume 2A, Chapter 1
- 'Centralised Procedure', the Rules governing Medicinal Products in the European Community, Notice to Applicants, Volume 2A, Chapter 4
- EU Pharmaceutical legislation - EudraLex Volume 1
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Draft EMEA policy on the practical operation of access to EMEA documents (PDF/53.44 KB)
First published: 18/12/2008
Last updated: 18/12/2008
EMEA/110196/2006/Final -
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Output of the draft EMEA policy on the practical operation of access to EMEA documents in the context of the authorisation and supervision of medicinal products for human and veterinary use (PDF/179.65 KB)
First published: 18/12/2008
Last updated: 18/12/2008
EMEA/659316/2008/Final -
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Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework (PDF/102.39 KB)
Adopted
First published: 18/03/2009
Last updated: 18/03/2009
Legal effective date: 01/09/2005
EMEA/P/24143/2004 Rev. 1 corr -
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Overview of comments received on draft guideline procedure for EU guidelines and related documents within the pharmaceutical legislative framework (PDF/196.26 KB)
First published: 24/06/2005
Last updated: 24/06/2005
EMEA/125817/2004