See the full regulatory and procedural guidance index.
Table of contents
Legislation
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework | (English only) | adopted | 18/03/2009 | 01/09/2005 | |
| Overview of comments received on draft guideline procedure for EU guidelines and related documents within the pharmaceutical legislative framework | (English only) | 24/06/2005 |
Related links
- 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
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| 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 | (English only) | 03/05/2006 |
EMA experts
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Policy on the handling of conflicts of interests of Management Board and scientific committee members and European Medicines Agency experts | (English only) | 08/06/2006 | |||
| EMEA procedure on the handling of conflicts of interests for EMEA scientific committees members and EMEA experts | (English only) | 01/07/2006 | |||
| Public declaration of interests and confidentiality undertaking of European Medicines Agency (EMA) Management Board members, scientific committee members and experts | (English only) | 18/07/2008 | 27/05/2010 |
Acess to Documents
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Draft EMEA policy on the practical operation of access to EMEA documents | (English only) | 17/12/2008 | |||
| 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 | (English only) | 17/12/2008 | |||
| Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework | (English only) | adopted | 18/03/2009 | 01/09/2005 | |
| Overview of comments received on draft guideline procedure for EU guidelines and related documents within the pharmaceutical legislative framework | (English only) | 24/06/2005 |