Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The legislative framework for veterinary medicinal products in Europe under revision - A review on primary objectives, key issues, policy options and their impact assessment

Dr. Holger Berk (Abschlußjahr: 2012)

The current legislative framework for veterinary medicinal products in the EU, the last major revision of which has taken place in 2004, is considered to have substantial deficiencies in a range of respects. These deficiencies are standing in the way of achieving the primary objectives of veterinary medicinal products legislation:

• Improvement in the availability of safe and efficacious veterinary medicinal products of appropriate quality to protect both, animal health and public health
• Reduction of administrative burden for all stakeholders
• Effective operation of the internal (single) market for veterinary medicinal products.

Consequently, the Commission has committed itself in 2009 to review the legislation for veterinary medicinal products starting in 2010. This revision, which is currently ongoing, is performed in accordance with the better regulation strategy, which implies an involvement of the stakeholders (national competent authorities, EMA, HMAv, CVMP, veterinarians and industry) throughout the process. The stakeholders have been asked for their views on 8 key issues, solutions to which are expected to significantly contribute to reaching the primary objectives, in an online consultation in 2010.

Furthermore, a study with the aim of documenting the problems associated with EU legislation on veterinary medicinal products and assessing the impacts of proposed options for legislative reform was commissioned by the Commission. In the report of this study, published in July 2011, a set of 19 policy options has been presented (the ‘synthesis package’ of policy options), which address the specific key issues as underlying causes of the deficiencies implied in the primary objectives.

Ultimately, theses policy options should lead to concrete proposals of amendments of the current legislation by the Commission.

In this thesis the revision process is outlined regarding its primary objectives, key issues and policy options including their impact assessment. Critical aspects are discussed and a conclusion including an outlook on the further progress of the revision is made.

45 pages (including 1 annex of 2 pages)