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Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.
Guideline on GVP
The guideline on GVP is divided into chapters that fall into two categories:
- modules covering major pharmacovigilance processes;
- product- or population-specific considerations.
Each chapter is developed by a team consisting of experts from the European Medicines Agency and from EU Member States.
The guideline on GVP is a key deliverable of the 2010 pharmacovigilance legislation.
Modules covering major pharmacovigilance processes
In total, there are 16 GVP modules covering major pharmacovigilance processes.
Most modules are available in their final versions. The full set of final modules is scheduled to be available during 2013.
The remaining modules below are under development and are scheduled for release for an eight-week public consultation as indicated below:
| Module number | Module title | Date of release for public consultation |
| XI | Public participation in pharmacovigilance | Third quarter 2013 |
| XII | Continuous pharmacovigilance, ongoing benefit-risk evaluation, regulatory action and planning of public communication | Third quarter 2013 |
| XIV | International cooperation | Third quarter 2013 |
| XVI | Risk-minimisation measures: selection of tools and effectiveness indicators | Second quarter 2013 |
Module XIII on incident management is no longer under development. All topics originally intended to be covered in this module are now to be included in module XII.
Product- or population-specific considerations
The chapters on product- or population-specific considerations are currently under development. They are being released for public consultation one by one. See draft GVP chapters and annexes for public consultation below.
Archives of documents
Table of contents
- Introduction
- Final GVP chapters
- Final GVP Annex I - Definitions
- Final GVP annex II - Templates
- Final GVP annex III - Other pharmacovigilance guidance
- Final GVP annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance
- Final GVP annex V - Abbreviations
- Draft GVP chapters and annexes for public consultation
- Templates for submission of comments
- Privacy statement for public consultation
Introduction
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with launch of public consultation of module VII revision 1, final module X and revision of module VIII, new annexes and final GVP webpage structure | (English only) | 25/04/2013 |
Final GVP chapters
Related links
Module XIII on incident management is no longer under development. All topics originally intended to be covered in this module are now to be included in module XII.
Where GVP modules refer to the European Medicines Agency's and the Heads of Medicines Agencies' procedural advice on referral procedures for safety reasons, consult:
Final GVP Annex I - Definitions
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Guideline on good pharmacovigilance practices: Annex I - Definitions | (English only) | adopted | 25/06/2012 | 13/12/2012 | 12/12/2012 |
Final GVP annex II - Templates
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Guideline on good pharmacovigilance practices: Annex II - Templates: Direct healthcare-professional communication | (English only) | adopted | 24/01/2013 | 23/01/2013 | |
| Guideline on good pharmacovigilance practices: Annex II – templates: Cover page of periodic safety update report (PSUR) | (English only) | adopted | 25/06/2012 | 25/04/2013 | 25/04/2013 |
Related links
For other templates developed outside the GVP process, see:
Final GVP annex III - Other pharmacovigilance guidance
Related links
These pharmacovigilance guidance documents were developed under the previous legal framework but are still valid in conjunction with GVP.
For other pharmacovigilance guidance developed outside the GVP process, see:
Final GVP annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance
Related links
- ICH E2B(R2): Maintenance of the ICH guideline on clinical safety-data management: Data elements for transmission of individual case safety reports
- ICH M1 Medical Dictionary for Regulatory Activites (MedDRA)
- MedDRA points-to-consider documents on term selection and on data retrieval and presentation are available on MedDRA points to consider documents.
- ICH M2 electronic standards for the transfer of regulatory information (ESTRI) is available on multidisciplinary guidelines.
Final GVP annex V - Abbreviations
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Guideline on good pharmacovigilance practices: Annex V – Abbreviations | (English only) | 25/04/2013 |
Draft GVP chapters and annexes for public consultation
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Guideline on good pharmacovigilance practices: Module VII – Periodic safety update report | (English only) | draft: consultation open | 25/04/2013 | ||
| Guideline on good pharmacovigilance practices (GVP): Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases | (English only) | draft: consultation open | 12/04/2013 | ||
| Guideline on good pharmacovigilance practices (GVP): P I - Vaccines for prophylaxis against infectious diseases – Definitions for inclusion in GVP annex I | (English only) | draft: consultation open | 12/04/2013 |
Templates for submission of comments
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Submission of comments on good pharmacovigilance practices (GVP) module VII – Periodic safety update report | (English only) | 25/04/2013 | |||
| Submission of comments on guideline on good pharmacovigilance practices (GVP): Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases | (English only) | 12/04/2013 | |||
| Submission of comments on guideline on good pharmacovigilance practices (GVP): P I - Vaccines for prophylaxis against infectious diseases – Definitions for inclusion in GVP annex I | (English only) | 12/04/2013 |
Privacy statement for public consultation
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Specific privacy statement: Public consultation of good pharmacovigilance practices | (English only) | 22/02/2012 |