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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).


IFAH-Europe's vision is for a regulatory process that can deliver a true single market for these products via a single European 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 how a single European marketing authorisation could work and the benefits of a more harmonised system for Europe.

A single licensing system for veterinary medicines

 A single European licensing system for veterinary medicines would follow a simplified submissions procedure for marketing authorisations, such as:

- 1 single EU dossier in English submitted to a scientific expert committee which assigns the assessment team. This assessment team could be multi-national or 'local' depending on the needs of the product and the applicant;

- 1 single assessment, peer reviewed, using the best expertise available in Europe and with a single fee paid to the centrally;

- 1 decision for marketing authorisation valid in all member states, with the payment of a national fee to each member state where the product is placed on the market (pay and do).

and this for ALL products.


Why do we need a single system?

The current licensing system in Europe is complex, leading to a high administrative burden and inefficiencies. A lack of sufficient alignment between member states implementing the legislation and guidelines creates additional bureaucratic hurdles.

A single European licensing system is a preferred solution as it would maintain existing safety standards, and:

  • Improve veterinary medicines availability
  • Reduce administrative burden, thereby improving competitiveness
  • Ensure a harmonized and practical implementation of the legislation leading to predictable, efficient and proportionate regulatory procedures
  • Achieve the key objectives of 'Better Regulation' and simplification, creating a regulatory environment proportionate to the needs of the animal health industry
  • Ensure efficient utilisation of resources within national competent authorities.

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