Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Proposal for a Regulation on Veterinary Medicinal Products in the EU – Comparison to the Existing Legislation and Evaluation of the Differences

Dr. Andrea Pinsker (Abschlußjahr: 2015)

Summary
Language: English
The revision of the legislative framework was seen as essential for increasing the availability of veterinary medicinal products in the European Union. In 2009 the Commission committed itself to rework the legislative framework. Therefore an impact assessment was started analysing the opinions of all relevant stakeholders (industry representatives and regulators), which identified three primary objectives of the legislation for veterinary medicinal products:

  • Improvement of the availability of veterinary medicinal products
  • Reduction of administrative burden
  • Effective operation of the internal single market

In September 2014 a Proposal for a new Regulation on veterinary medicinal products was published. While the fundamental procedures MRP and CP for obtaining a marketing authorisation remained unchanged, the decision process during the DCP is significantly changed to a majority decision, the scope of the CP is expanded and a simple recognition procedure for the extension of marketing authorisations to additional countries is introduced.
Additionally, elongation of data protection periods, reduced labelling requirements and a significant reduction of the administrative burden for maintaining the pharmacovigilance system are included.
These measures aim at providing incentives for increasing the number of marketing authorisation applications and increasing the availability of veterinary medicinal products.
On the other hand, implementation of a database on sales data and increased pharmacovigilance reporting requirement increase the administrative burden on regulators and industry.
Additionally, the Proposal addresses the topic of antimicrobial resistance and by providing several measures to limit and monitor the use of antibiotics.
Pages: 45, Annexes: 3 with 5 pages

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