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See the full regulatory and procedural guidance index
Important note on document formats: All Microsoft Office documents submitted to the European Medicines Agency must be in a format compatible with MS Office 2003. Office 2007 and Office 2010 formats cannot currently be accepted.
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Questions and Answers on variations to an existing pharmacovigilance system as described in the DDPS | (English only) | adopted | 02/03/2011 | ||
| European Medicines Agency post-authorisation procedural advice for users of the centralised procedure | (English only) | 01/07/2009 | 26/04/2012 | ||
| European Medicines Agency procedural advice for users of the centralised procedure for generic/hybrid applications | (English only) | 02/07/2008 | 26/01/2012 | ||
| Procedural advice to CHMP members | (English only) | adopted | 06/08/2008 | ||
| Procedural advice on the re-examination of CHMP opinions | (English only) | draft: consultation closed | 12/02/2009 | ||
| Guidance for the provision of data (excluding paediatric data) not yet submitted to the EMEA | (English only) | adopted | 13/09/2005 |
Related links
- 'Centralised Procedure', the Rules governing Medicinal Products in the European Community, Notice to Applicants, Volume 2A, Chapter 4
- 'Decision Making Procedure for the Adoption of Commission Decisions', the Rules governing Medicinal Products in the European Community, Notice to Applicants, Volume 2A, Chapter 6
- Guideline on aspects of the application of Article 8(1) and (3) of Regulation (EC) No 141/2000: Assessing similarity of medicinal products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivity
- Guideline on changing the classification for the supply of a medicinal product for human use
- Issues arising in the context of authorising non-prescription medicinal products through the centralised procedure