Fidin

Bijlage V Relevante farmacovigilantie bronnen

Verordening (EU) 2019/6

Uitvoeringsverordening (EU) 2021/1281

Regeling diergeneesmiddelen 2022

Besluit diergeneesmiddelen 2022

‘Guidelines on veterinary good pharmacovigilance practices (VGVP guidelines)’ van de EMA, bestaande uit:

• Module: Collection and recording of suspected adverse events for veterinary medicinal products (EMA/306663/2021)
• Module: Signal Management (EMA/522332/2020)
• Module: Veterinary pharmacovigilance communication (EMA/63454/2021)
• Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files (EMA/595115/2021)
• Module: Controls and pharmacovigilance Inspections (EMA/328998/2021)
• Module: Glossary (EMA/118227/2021)

Website van de EMA waar de meest recente lijst VeDDRA-termen beschikbaar is 

Website van het Bureau Diergeneesmiddelen