Medicinal Products for Veterinary Use
Revision of the legal framework for veterinary medicinal products
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 :
“…an 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.
An online public consultation was carried out between 13 April and 15 July 2010:
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:
A stakeholder meeting took place on 23rd September 2011:
Targeted expert meetings took place:
- Summary report of experts' meeting with SMEs to discuss the review of the veterinary medicinal product legislation
- Summary report of expert meeting on authorisation procedures and data protection in the context of the review of the veterinary medicinal products legislation
- Summary report of expert meeting on antimicrobial resistance in the context of the review of the legislation on veterinary medicinal products
- Summary report of expert meeting on pharmacovigilance in the context of the review of the veterinary medicinal products legislation
The revision will contribute to realisation of certain actions in the Animal Health Strategy .
Unit SANCO D3 - Pharmaceuticals
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.
- Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products
- Annexes to the Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products
- Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
- Executive Summary of the Impact Assessment
- Impact Assessment
- Opinion of the Impact Assessment Board
- Press release and Q§A on veterinary medicines and medicated feed proposals
For further information, contact SANCO-PHARMACEUTICALS-D6@ec.europa.eu.