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Regulatory Affairs

Bringing veterinary medicines to market

In the European Union, an effective and rigorous examination and registration system exists for placing veterinary medicinal products on the market. The EU registration process (a.k.a. marketing authorisation process) ensures that only those products meeting defined standards of quality, safety and efficacy, which have been thoroughly tested and carefully reviewed by independent experts, reach the marketplace. Check-out our infographic on how veterinary medicines come to market.

This is a lengthy and complex procedure and is ultimately designed to protect the public, animals and the environment from poor quality or unsafe medicines. The links below outline the steps involved in this process.


All aspects of risk are considered during the registration process. Safety is the number one priority. If there is any doubt about either the quality of the data in a dossier or the safety of the product concerned, Marketing Authorisation will either be refused, or will be granted subject to the imposition of additional safety requirements.

In order to qualify for Marketing Authorisation, a product must be demonstrably safe for:

  • animals;
  • consumers of animal produce;
  • users (farmers, veterinary surgeons, pet owners etc.); and
  • the environment.

Companies must conduct in-depth studies and provide detailed data demonstrating the safety of their products.

Quality and Efficacy

A manufacturer must demonstrate not only the quality of a finished product, but also the consistent quality of the raw materials and manufacturing processes involved in its production. The product must be stable, which means that its quality and efficacy are ensured at least until the stated best before date.

The manufacturer must substantiate claims for the effectiveness of a product. It must demonstrate in detailed field trials that the product is effective in preventing or treating a medical condition, in accordance with statements made on product labelling and information sheets.


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