Clinical trials

Clinical trial of veterinary medicinal products in accordance with Regulation (EU) 2019/6

The new EU Veterinary Medicinal Products Regulation, which entered into force on 27/01/2019, is applicable from28/01/2022. According to Article 9 of this Regulation, applications for approval of clinical trials of veterinary medicinal products must be submitted to the competent authority of the Member State in which the clinical trial is to be conducted. In Austria, the BASG is the competent authority for this purpose.

Irrespective of this, the application for approval of the clinical trial must be submitted to the competent ethics committee. The Federal Ministry of Social Affairs, Health, Care and Consumer Protection is currently working on more detailed national regulations for clinical trials of veterinary medicinal products.

Definition: clinical trials of veterinary medicinal products are studies intended to investigate, under field conditions, the safety or efficacy of an investigational product/animal medicinal product under normal conditions of animal husbandry or in the context of normal veterinary practice for the purpose of obtaining a marketing authorization or the amendment of such an authorization.

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