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Regulatory Affairs

When people get sick they rely on modern medicine to make them better and this is done without a second thought because they know that the manufacturers have spent years developing their products to ensure their effectiveness and safety. The animal health industry also invests huge resources in developing, testing and manufacturing safe, effective veterinary medicines and Europe has one of the world’s most stringent licensing systems for controlling medicines (see Bringing veterinary medicines to market).

EFFICIENT REGULATION

IFAH-Europe's vision is for a regulatory process that can deliver a true single market for these products via what the federation has named the “1-1-1 Concept” – i.e. one dossier, one scientific assessment and one decision for marketing authorisation for all animal health products. 

Adherence to common standards at a global level is also important and as such IFAH-Europe promotes a Global Regulatory Strategy for Veterinary Medicines and is active in the VICH, a trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration. 

The links below give more detail on the 1-1-1 Concept and the benefits of a more harmonised system for Europe.

A single market for veterinary medicines

The road to a single EU market for veterinary medicines began with the first European Directive in 1981. During the last 30 years significant milestones have been achieved in realising this objective through significant updates and revisions of the legislation. To assist with the preparation of the European commission’s impact assessment on proposed revisions to EU legislation on veterinary medicinal products, IFAH-Europe prepared a comprehensive Impact Assessment Data Package.

IFAH-Europe now has one vision: to complete the journey to one true single market in veterinary medicinal products now through the ongoing review of the legislative framework (2010-2014). 

Common goals 

  • A single market for veterinary medicines in Europe.
  • The availability of safe, efficacious veterinary medicines of appropriate quality to protect both animal health and public health.

Objectives

  • Enhanced availability of veterinary medicines
  • Efficient use of resources 
  • Simplified yet robust regulatory system

Downloads

The Animal Health Industry - Our Value to Society

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