PHARMACOVIGILANCE

Veterinary medicines

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Veterinary medicines

The new Veterinary Medicines Regulation (Regulation (EU) 2019/6) will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union (EU) when it becomes applicable on 28 January 2022.

WE OFFER YOU

  • Effective implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6)
  • Compliance with Volume 9B
  • Services of a QPPV (24/7) with access to veterinarian doctor
  • Establishment and maintenance of the DDPS
  • Establishment and maintenance of the Pharmacovigilance and Quality System, including Training of personnel
  • The collection, processing (including data entry and data management), quality control, coding, classification, veterinary review and reporting of adverse events
  • Continuous management of safety profile
  • Preparation of Risk Management Systems
  • Medical writing (PSUR, protocols for studies)
  • Setting up appropriate Contractual arrangements and supervision
  • Audit and Pre-inspection consultations
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OUR SERVICES - WE FORSEE AND ADAPT