Services

Pharmacovigilance

Veterinary Medicines

 The Veterinary Medicines Regulation (Regulation (EU) 2019/6) has modernised the existing rules on the authorisation and use of veterinary medicines in the European Union (EU) and has become applicable on 28 January 2022.

How to Reach us?

Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202

1000 Ljubljana

Slovenia

Our services:

  • Efective implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6)
  • Compliance with good pharmacovigilance practice for veterinary medicinal products (VGVP)
  • Services of a QPPV (24/7) with access to veterinary doctor
  • Establishment and maintenance of the pharmacovigilance system master file (PSMF)
  • Establishment and maintenance of the Pharmacovigilance and Quality System,
    including training of personnel
  • Collection, recording and reporting of suspected adverse events for
    veterinary medicinal products
  • Continuous assessment of the benefit-risk balance
  • Continuous signal management
  • Setting up appropriate contractual arrangements and supervision
  • Audit and pre-inspection consultations

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