Current legal framework for veterinary medicines in the European Union
The marketing of veterinary medicines in the European Union (EU) is regulated by a strict legal framework that ensures their safety, quality, and efficacy. This common system aims to protect both animal and public health by minimizing risks such as residues in food of animal origin and antimicrobial resistance.
Since January 2022, Regulation (EU) 2019/6 on veterinary medicinal products has modernized the previous legislation (Directive 2001/82/EC), harmonizing authorization procedures across all Member States and adapting them to scientific advances.
Regulation of Veterinary Medicines: Regulation (EU) 2019/6
This regulation governs all aspects related to veterinary medicines: authorization, manufacturing, distribution, use, and pharmacovigilance. As a directly applicable regulation, it eliminates the need for national transposition, promoting uniform legislation and facilitating intra-EU trade.
One of its key principles is that any veterinary medicinal product must be safe for animals, humans, and the environment, as well as demonstrate efficacy and quality.
Authorization Procedures in the EU
There are several procedures for obtaining authorization of a veterinary medicinal product, depending on the marketing strategy:
- Centralized procedure (mandatory for innovative or biotechnology-based products): managed by the EMA and valid throughout the EU.
- Decentralized procedure: allows for simultaneous authorization in multiple countries.
- Mutual recognition procedure: extends a previously granted national authorization to other Member States.
- National procedure: valid only in the country where it is requested.
Technical Documentation and Scientific Evaluation
To begin with, the applicant must submit a complete technical dossier containing information on the composition, manufacturing process, clinical trials, and safety and efficacy studies of the veterinary medicine. In the case of animals intended for human consumption, the dossier must also comply with Maximum Residue Limits (MRLs). The competent authorities or the EMA evaluate this data based on common scientific criteria.
Environmental Impact and Responsible Use of Medicines
One of the key requirements is the assessment of environmental impact. If risks are identified, mitigation measures may be imposed. Furthermore, the regulation also promotes the responsible use of antibiotics to combat antimicrobial resistance, including potential usage restrictions or mandatory veterinary prescriptions.
Registration and Post-Authorization Monitoring
Once authorized, the medicine is listed in the European Union Product Database for Veterinary Medicines. Marketing authorization holders must comply with pharmacovigilance obligations, reporting any adverse effects detected after the product is placed on the market. This ensures continuous updates to the medicine’s risk-benefit assessment.
