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Veterinary Medicinal Products - Guidance to Applicants for Marketing Authorisations Under Regulation (EU) 2019/6

  • 16/02/2024
  • News

On 14 February 2024, the Official Journal of the European Union published a Commission Notice providing guidance to applicants (the Guidance) for marketing authorisations (MAs) for veterinary medicinal products (VMPs) under Regulation (EU) 2019/6 of 11 December 2018 on veterinary medicinal products (Regulation 2019/6).
The 44-page Guidance was developed by the European Commission in consultation with the competent authorities of the Member States and the European Medicines Agency. It aims to assist stakeholders, and applicants for MAs for VMPs in particular, in complying with their obligations under Regulation 2019/6. Regulation 2019/6 applies since 28 January 2022 and repealed Directive 2001/82/EC (see, Van Bael & Bellis Life Sciences News and Insights of 10 January 2019).
The Guidance describes the ways and conditions for obtaining MAs for VMPs and also governs their lifecycle management, including the need to continuously update them to take account of scientific and technical progress and new regulatory requirements (sections 1-4). Further, it clarifies the rules that protect technical documentation (section 5). Section 6 of the Guidance discusses the mandatory environmental risk assessment for new MAs for VMPs imposed by Regulation 2019/6.
Although the Guidance carries significant weight, it notes that only the Court of Justice of the European Union is competent to authoritatively interpret Regulation 2019/6.

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