General: Regulatory and procedural guidance

Legislation

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

Adopted Reference Number: EMEA/P/24143/2004 Rev. 1 corr Legal effective date: 01/09/2005

• 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

Phasing in new legislation

Practical considerations on the impact of the new pharmaceutical legislation on marketing authorisation applications via the centralised procedure and centrally authorised products for human use

Reference Number: EMEA/243280/2005 – Rev 2

EMA experts

Breach of trust procedure for competing interests and disclosure of confidential information by European Medicines Agency’s scientific committees’ members and experts

Adopted Reference Number: EMA/154320/2012 Rev.4

Access to Documents

Draft EMEA policy on the practical operation of access to EMEA documents

Reference Number: EMEA/110196/2006/Final

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

Reference Number: EMEA/659316/2008/Final

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

Adopted Reference Number: EMEA/P/24143/2004 Rev. 1 corr Legal effective date: 01/09/2005

Overview of comments received on draft guideline procedure for EU guidelines and related documents within the pharmaceutical legislative framework

Reference Number: EMEA/125817/2004