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The pharmacovigilance guidelines drawn up by the European Commission in accordance with Article 106 of Directive 2001/83/EC of the European Parliament and the Council are published as Volume 9A of The Rules Governing Medicinal Products in the EU.
Other guidelines not incorporated in Volume 9A as well as current and historical concept papers and draft guidelines under public consultation are contained in the table below.
See the full regulatory and procedural guidance index.
Table of contents
- Guidance for marketing authorisation holders
- Guidance for competent authorities and the agency
- Product type - and population - specific guidance
- Pharmacovigilance practices
Guidance for marketing authorisation holders
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Distribution requirements and address lists for periodic safety update reports | (English only) | 06/07/2001 | 20/04/2011 | ||
| Concept paper on compliance with pharmacovigilance regulatory obligations | (English only) | adopted | 15/11/2001 | 01/01/2002 | |
| Template for EU risk management plan (EU-RMP) | (English only) | adopted | 27/09/2006 |
Guidance for competent authorities and the agency
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Handling by the CPMP of safety concerns for pre- and post-authorisation applications submitted in accordance with the centralised procedure | (English only) | adopted | 05/04/2004 |
Product type - and population - specific guidance
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases | (English only) | adopted | 22/07/2009 | 01/10/2009 | |
| Overview of comments received on draft guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases (EMEA/CHMP/PHVWP/503449/2007) | (English only) | 22/07/2009 | |||
| Draft guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases | (English only) | draft: consultation closed | 25/09/2008 | ||
| Concept paper for a guideline on the conduct of pharmacovigilance for vaccines | (English only) | 11/10/2005 | |||
| Guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data | (English only) | adopted | 13/11/2005 | 31/10/2005 |