The World of Veterinary Medicines

EU Regulatory requirements and the Challenges facing the industry

Blog 20 - image sick-dogBefore a veterinary medicine can be placed on the market for sale or for prescription, it is subject to the granting of a marketing authorisation (MA) by the competent authority of the country where it will be used or by the European Commission (EC), following a benefit/risk assessment. To facilitate this, legislations are in place to safeguard animal health and welfare as well as public health.

Revision of Veterinary Medicines Legislation

Movement towards a single EU-wide authorisation

Veterinary MedicineIt was announced at the TOPRA 7th Annual Veterinary Medicines Symposium in Dublin in 2012 that significant changes would be made to the current Veterinary Medicines legislation (Veterinary Medicines Directive).

Four main problems were identified by industry:

  • High administrative burdens
  • Lack of availability of veterinary medicines
  • Risk of antimicrobial resistance
  • Deficient operation of single market