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Pharmacovigilance

New Guidance on veterinary good pharmacovigilance practices applicable from 28 January 2022

New Guidance on veterinary good pharmacovigilance practices applicable from 28 January 2022

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) contains new legal provisions on veterinary pharmacovigilance.

These aim to focus on continuous signal management based on adverse event data in the ‘Union Pharmacovigilance Database’ and cover pharmacovigilance inspections and the maintenance of pharmacovigilance master files.

To assist marketing authorization holders in fulfilling their pharmacovigilance obligations, the EMA will provide a guideline on good veterinary pharmacovigilance practice (VGVP guideline), which will replace the current veterinary pharmacovigilance guidelines as of January 28, 2022.

A draft VGVP guideline is available for public consultation (click here)

Azierta offers a 360º animal health consulting services that provides tailored solutions throughout the product life cycle including:

  • Research and development: Support to Phase I-III research.
  • Marketing authorisation application: Next-generation registration ​Process. (De)Centralized process​. Guide to registration of Vet products to EMA​.
  • Post- authorisation: Updating all components of drugs, biologics and vaccines filing., and also Pharmacovigilance.

 

 

+ More Info:

https://www.ema.europa.eu/en/veterinary-regulatory/post-authorisation/pharmacovigilance