Implementation of the veterinary medicinal products regulation

Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal product was adopted by the European Union to modernize and streamline the regulatory framework veterinary medicinal products, aiming at creating a more efficient, transparent and secure regulatory environment for veterinary medicinal products within the EU (“Regulation on Veterinary Medicinal Products”).

The Regulation on Veterinary Medicinal Products has been applicable since January 28, 2022. Despite its innovative and modern approach to the veterinary medicinal products market, some of its provisions have been raising concerns amongst stakeholders, specifically regarding the rules applicable to the authorization process of multinational/multicentric clinical trials.

Essentially, according to Article 9 of the Regulation on Veterinary Medicinal Products, clinical trials concerning veterinary medicinal products must be approved by the competent authorities of the Members States in which the clinical trial is to take place.

However, the Regulation does not detail how the assessment procedures should proceed and, in particular, how can national authorities be organized in order to ensure a coordinated assessment of multicenter/multinational clinical trials. This lack of regulation becomes particularly evident when comparing this regime with the regime applicable to clinical trials with medicinal products for human use, approved by Regulation (EU) no. 536/2014 of the European Parliament and of the Council, of April 16, 2014 (“Clinical Trials Regulation”), which foresees in detail a centralized procedure for the authorization of clinical trials, with a clear definition of the roles of each national authority and clear guidelines to sponsors.

Given this insufficiency of the Regulation on Veterinary Medicinal Products, three main documents with guidelines on good practices and application and questionnaire forms have been proposed for a two-months consultation period to overcome the difficulties faced and to ensure a well-organized assessment procedure of clinical trials on veterinary medicinal products throughout the European Union.

Besides including an application and a questionnaire form to be used by applicants, we understand that the most relevant document consists of a Guide for applications and Member States, which defines the application procedure to be followed and, more importantly, the deadlines to be observed. These documents will be available for public consultation until August 30, 2024, and can be accessed through this link.

Having in mind the importance of the definition of these procedures, it is advisable for the veterinary medicinal products industry to actively participate and engage, with a view to contribute with their expertise and insights, ensuring that the guidelines to be followed are practical, effective and grounded in real-world experience