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 (EMA) 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 was a key deliverable of the 2010 pharmacovigilance legislation.
Each chapter and revisions are developed by a team consisting of experts from EMA and from EU Member States.
The guideline on GVP is divided into chapters that fall into two categories:
- modules covering major pharmacovigilance processes;
- product- or population-specific considerations.
Modules covering major pharmacovigilance processes
GVP modules I to XVI cover major pharmacovigilance processes and the development of this set of guidance is concluded. The module numbers XI, XII, XIII and XIV stay void, as their planned topics have been addressed by other guidance documents on the Agency's website (see bullet points below Final GVP modules table).
Product- or population-specific considerations
The chapters on product- or population-specific considerations are available for vaccines, biological medicinal products and the paediatric population. EMA plans one more consideration chapter as follows:
Chapter number | Preliminary chapter title | Date of release for public consultation |
P V | Geriatric population | To be announced |
GVP modules and considerations are regularly reviewed for revision needs and schedules.
Archives of documents
Introduction
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with release of Addendum III of Module XVI on pregnancy prevention programmes for public consultation
Final GVP modules
Guideline on good pharmacovigilance practices: Module I – Pharmacovigilance systems and their quality systems
Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (Rev. 2)
Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections
Guideline on good pharmacovigilance practices (GVP) - Module IV – Pharmacovigilance audits (Rev. 1)
Guideline on good pharmacovigilance practices: Module V – Risk management systems (Rev. 2)
Guideline on good pharmacovigilance practices (GVP) - Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev. 2)
Guideline on good pharmacovigilance practices (GVP) - Module VI Addendum I – Duplicate management of suspected adverse reaction reports
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report
Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 3)
Guideline on good pharmacovigilance practices (GVP): Module VIII Addendum I - Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 3)
Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1)
Guideline on good pharmacovigilance practices (GVP): Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions
Guideline on good pharmacovigilance practices: Module X – Additional monitoring
Guideline on good pharmacovigilance practices: Module XV – Safety communication (Rev. 1)
Guideline on good pharmacovigilance practices: Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev. 2)
Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials
- Where GVP chapters refer to Modules XI or XIV, consult the Agency's page on partners and networks.
- Where GVP chapters refer to Module XII, consult the Agency's page on post-marketing authorisation: regulatory and procedural guidance for human medicinal products.
- Where GVP chapters refer to Module XIII, consult the Agency's page on the incident management plan.
- Please note the document on Reporting requirements of marketing authorisation holders in the European Union (EU) regarding suspected adverse reactions occurring with medicinal products they donate outside the EU to public health programmes against ....
- In relation to the GVP VII module please note that an Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note and a Questions and answers on PSUSA: Guidance document for assessors have been developed to clarify certain aspects of the single assessment that are specific to nationally authorised products. These documents should be considered as interim guidance until the GVP VII module is revised as per the established process. Once the updated GVP module is published this guidance will be removed. These documents can be found on the Periodic safety update reports: questions and answers page.
- 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 referral procedures page.
Final GVP product- or population-specific considerations
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products
Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations IV: Paediatric population
Final GVP annex I - Definitions
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 4)
Final GVP annex II - Templates
Guideline on good pharmacovigilance practices: Annex II – Templates: Cover page of periodic safety update report (PSUR)
Guideline on good pharmacovigilance practices: Annex II – Templates: Direct Healthcare Professional Communication (DHPC) (Rev. 1)
Guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)
For other templates developed outside the GVP process, see:
Final GVP annex III - Other pharmacovigilance guidance
These pharmacovigilance guidance documents were developed under the previous legal framework but are still valid in conjunction with GVP.
Guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data
Note for guidance: EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) (historical)
Overview of comments received on draft note for guidance: EudraVigilance version 7.1 - Processing of safety messages and individual case safety reports (ICSRs)
Draft note for guidance: EudraVigilance Human version 7.1 - Processing of safety messages and individual case safety reports (ICSRs)
For other pharmacovigilance guidance developed outside the GVP process, see:
- Pharmacovigilance: regulatory and procedural guidance
- Consideration on core requirements for RMPs of COVID-19 vaccines
- Signal management
- EudraVigilance
- European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 3
- Union reference dates and submission of periodic safety update reports
- Guideline on registry-based studies
- Standards and guidances of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
- Guideline on key aspects for the use of pharmacogenomics in the pharmacovigilance of medicinal products
- Good practice guide on recording, coding, reporting and assessment of medication errors.
- Good practice guide on risk minimisation and prevention of medication errors
- Risk minimisation strategy for high-strength and fixed-combination insulin products, addendum to the good practice guide on risk minimisation and prevention of medication errors
Also, note the PRAC rules of procedure.
Final GVP annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 A: Clinical safety data management: Definitions and standards for expedited reporting - Step...
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2B (R3): Electronic transmission of individual case safety reports (ICSRs) - data elements ...
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 B (R3): Questions and answers: Data elements for transmission of individual case safety repo...
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2C (R2) on periodic benefit-risk evaluation report - Step 5
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 D: Postapproval safety data management - Step 5
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 E: Pharmacovigilance planning - Step 5
ICH guideline E2F on development safety update report - Step 5
- E2C(R2)Implementation working group ICH E2C(R2) Guideline: Periodic benefit-risk evaluation report questions & answers
- ICH M1 Medical Dictionary for Regulatory Activites (MedDRA)
- MedDRA support documentation
- ICH M2 electronic standards for the transfer of regulatory information (ESTRI) is available on multidisciplinary guidelines.
Final GVP annex V - Abbreviations
Guideline on good pharmacovigilance practices: Annex V – Abbreviations (Rev. 1)
Public consultations
Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum III – Pregnancy prevention programme and other pregnancy-specific risk minimisation measures
Those participating in the public consultation are asked to submit comments via the EU survey tool linked here.
Draft guideline on good pharmacovigilance practices: Product- or population-specific considerations III: Pregnant and breastfeeding women
Guideline on good pharmacovigilance practices (GVP): Module XVI - Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3)
Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II - Methods for effectiveness evaluation