REGULATORY AFFAIRS

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

  • Cost effective regulatory strategies to gain competitive advantage

For new products development

For existing registered products (re-development, re-registration, etc.)

  • Project management
  • Compliance check/due diligence, updating and reformatting of files
  • Choosing the most appropriate type of procedure
  • Handling all type of registration procedures for various products in VNeeS
  • Consultation on legal basis and classification of products
  • Handling registration procedures in all EU Member States
  • Preparation of Part I-IV
  • CMC documentation preparation (API and FDF)
  • MRL application
  • Life cycle management
  • Environmental risk assessment (ERA)
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