Medicinal products for veterinary use

Revision of the legal framework for veterinary medicinal products


General information

In the context of co-decision procedure concerning the proposal for a Regulation on residue limits of pharmaceutical products in foodstuffs the Commission made the following declaration:
" assessment of the problems in the application of the veterinary medicinal products directive with a view to making, where appropriate, legal proposals."
COM (2008) 912, 8.1.2009.

The revision is included in the Commission Work Programme in a package with a proposal for revision of medicated feed legislation.
Commission Work Programme see point 18 on page 23.

The purpose of this revision will be to increase the availability of veterinary medicinal products, to reduce the administrative burden on enterprises, to improve the functioning of the internal market for veterinary medicinal products and to assess the possibilities to have an improved response to antimicrobial resistance related to the use of veterinary medicines. In the roadmap are described the problem definition, the objectives and the options of the initiative.

The revision will contribute to realisation of certain actions in the Animal Health Strategy.


Major developments

Adoption of proposal by European Commission.

On 10 September 2014 the European Commission has adopted a pair of proposals on veterinary medicinal products and medicated feed. The proposal on veterinary medicinal products aims to:

  • Increase the availability of veterinary medicinal products;
  • Reduce administrative burden;
  • Stimulate competitiveness and innovation;
  • Improve the functioning of the internal market; and
  • Address the public health risk of antimicrobial resistance.

The proposed rules will benefit animals – including aquatic species, their holders, pet owners, veterinarians and businesses – including farmers and animal health industry.

Reply of Directorate General Health and Consumers to letters of Pestizid Aktions-Netwerk e.v..

Targeted expert meetings took place.

Stakeholders meeting.

Study carried out.

In 2010-2011 a study was carried out to quantify the main perceived problems, to suggest policy options to resolve them and to assess the impact.

The external report is available here.

Online public consultation.

An online public consultation was carried out between 13 April and 15 July 2010:

Key documents