Veterinary Drug Registration: coming from the USA to Europe

Comparison of Veterinary Drug Registration in the USA and Europe
31 July, 2018

If you are an animal health company, already well established in America, you will be closely familiar with the regulatory framework of the USA. Looking at export markets, Europe is highly attractive, but the system of product registration can seem impenetrable. To help you understand the European system Cyton and our US colleagues at knoell USA (KUSA) have put together a simple guide reviewing the key considerations for any American company looking to enter the EU.

Veterinary drug registration in the EU

In this overview document we review the following:

  • Regional harmonisation in Europe, the EU and Brexit - can I get one drug approval licence for all of Europe?
  • Terminology and product classification - what do Europeans call an animal drug?
  • Strategy - what are your options and what advice is available from the EU regulators?
  • Regulatory submissions - do Europeans have phased submission? What do EU regulators require instead of a New Animal Drug Application (NADA)?
  • Food producing animals - what are the rules regarding drug residues in food from treated animals and how is environmental impact assessed in Europe? 
  • Pharmacovigilance - does Europe have the same requirements for reporting adverse events associated with animal drugs?
  • Manufacturing and packaging - can I manufacture and package my product in the USA and export it to Europe?

The complete overview is included as a PDF document in the link at the bottom of this page. If you find this useful and would like to follow up with a more detailed discussion about your specific requirements, please do not hesitate to get in touch, in a range of languages, through our Contact Page.

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