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Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)
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Article 28Examination of applications
1.The competent authority or the Agency, as applicable, to which the application has been submitted in accordance with Article 6 shall:
(a)verify that the data submitted complies with the requirements laid down in Article 8;
(b)assess the veterinary medicinal product regarding the quality, safety and efficacy documentation provided;
(c)draw up a conclusion on the benefit-risk balance for the veterinary medicinal product.
2.During the process of examination of applications for marketing authorisations for veterinary medicinal products containing or consisting of genetically modified organisms as referred to in Article 8(5) of this Regulation, the Agency shall hold the necessary consultations with the bodies set up by the Union or Member States in accordance with Directive 2001/18/EC.
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