Guidance Documents
Pharmacovigilance is the process of monitoring the use of medicines in practice to identify previously unrecognised adverse events or changes in the patterns of known adverse events. These include both user safety and consumer safety. The guidelines below are links to the various bodies and only adopted guidelines are included. If you want additional information (such as Concept Papers, Draft Guidelines, comments etc.) please visit the websites.
- Relevant VMGNs
- Best Practice Guides
- Notice to Applicants
- CVMP Guidelines
- VICH Guidelines
- Variation Guidance
Best Practice Guides: (Further Best Practice Guides can be found on the HMA website)
Notice to Applicants (NtA): (Complete volumes of Eudralex can be found on the European Commission website)
CVMP Guidelines (Further safety guidelines can be found on the EMA website)
- Recommendation on management and assessment of periodic safety update reports (PSURs) of veterinary medicinal products
- Veterinary pharmacovigilance in the EU - A simple guide to reporting adverse reactions
- Guideline on a strategy for triggering pharmacovigilance investigations preceding regulatory actions by EU competent authorities
- Guideline on harmonising the approach to causality assessment for adverse reactions to veterinary medicinal products
- Guideline on procedures for competent authorities for pharmacovigilance information for veterinary medicinal products
- CVMP guideline on pharmacovigilance of veterinary medicinal products - Guidance on procedures for marketing authorisation holders
- Note for guidance pharmacovigilance of veterinary medicinal products
- Points to Consider regarding reporting of suspected Serious Adverse Reaction to Veterinary Medicinal Products: Common EU Reporting Form for Marketing Authorisation Holders
- EudraVigilance Veterinary Documentation
VICH Guidelines: (Further guidelines can be found on the VICH website)
- VICH GL24 - Pharmacovigilance of veterinary medicinal products: management of adverse event reports (AERs)
- VICH GL29 - Pharmacovigilance of Veterinary Medicinal Products - Management of Periodic Summary Update Reports
- VICH GL30 - Pharmacovigilance - Controlled List of Terms
- VICH GL35 - Pharmacovigilance : Electronic Standards for Transfer of Data Draft Guideline
- VICH GL42 - Pharmacovigilance of Veterinary Medicinal Products - Data Elements for Submission of Adverse Event Reports
