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October 2023 | Vol. 20 | No.9
This edition of Regulatory Rapporteur focuses on topics and developments specific to veterinary medicines, from challenges arising from new veterinary regulations to measures ensuring the safe and effective use of medicines and vaccines.
By Birgit Roser and Kornelia Grein
The product information template for veterinary medicines was updated from QRD V.8.2 to QRD v.9 to reflect requirements for labelling and packaging, and a five-year transition period has been set for existing market authorisations. This article discusses the key aspects that the revision entails for the years ahead.
By Elsa Vecino
Autogenous vaccines (AV) are now included in EU legislation for veterinary medicinal products following the implementation of Regulation (EU) 2019/6. The regulation acknowledges that AVs will require a specific set of manufacturing rules. This article reports on the work being completed to implement good manufacturing practice guidelines for AVs.
By Hans-Joachim Selbitz
The WHO prequalification scheme assesses the quality and safety of human medicines. The European Commission is working to create a similar scheme for veterinary medicines and vaccines. This article summarises the main aspects of the scheme, its status of development and the expectations for the future.
By Kornelia Grein, Martin Ilott, David Mackay and Mark Sellers
Renewed efforts have been made by the EMA, its Committee for Veterinary Medicinal Products and associated working parties to reflect evolving knowledge and requirements for veterinary medicinal products. This article provides an overview of current reflections and guidance for the development of antiparasitic veterinary medicinal products.
By Valentin Nicorescu and Barbara Cyrus
During the development of a new medical device, regulatory requirements concerning biocompatibility should be considered at every stage. By adopting proactive approaches to biocompatible material section, manufacturers can have a high degree of certainty in building safe and effective products. This article discusses biological evaluation standards and ways to optimise material selection.
By Jocivania Oliveira da Silva and Marielle Fournier