New data protection for maximum residue limits


Maximum residue limits (MRL) have been a requirement for all substances included in veterinary medicines intended for food-producing animals since the 1990s. The new Veterinary Medicines Regulation ([EU] 2019/6) provides an opportunity for data protection in relation to the data package submitted to the European Medicines Agency (EMA) when applicants request new or extended MRL. This could provide a real advantage for a product and may contribute to the availability of treatments for less prevalent animal species. The new rules and options deserve attention from the veterinary medicines industry. They aim to extend the range of products for use in many animal species and to repurpose old substances where generic competition is a hurdle for investment.

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