Veterinary medicines are licensed.

A licence means that veterinary medicines only reach the marketplace once their safety, quality and efficacy are clearly demonstrated, and after review by the relevant authorities.

• Safety: A veterinary product must be safe for animals, consumers, users (farmers, vets, pet owners, etc.), and the environment in order to qualify for a marketing authorisation or licence.
  
  These criteria are imposed stringently and animal health companies must conduct in-depth studies and provide detailed data demonstrating the safety of their medicines.

• Quality: 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 is ensured at least until the stated ‘best before’ date.

• Efficacy: A manufacturer must substantiate claims regarding the effectiveness of a product. They must demonstrate through detailed field trials that the product is effective in preventing or treating a medical condition, in accordance with the statements made on the product labeling and information sheets.

Regulatory framework

Each EU Member State has its own independent regulatory authority, which performs independent scientific evaluations of veterinary medicines. Additionally, the European Medicines Agency, based in London, is a pan-EU regulatory agency for human and veterinary medicines.

The registration requirements for all EU Member States have been harmonised. However, some medicines are only needed in certain Member States due to the geographical location of certain diseases or to climate conditions.

The system is therefore flexible and includes four different routes through which a licence can be obtained:

• The national procedure
• The mutual recognition procedure
• The centralised procedure
• The decentralised procedure.

See further information in the IFAH-Europe dossier on “The marketing authorisation process for veterinary medicinal products in Europe”.