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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) article 43 CELEX: 02019R0006-20220128 Application for centralised marketing authorisation
1. An application for a centralised marketing authorisation shall be submitted to the Agency. The application shall be accompanied by the fee payable to the Agency for the examination of the application. 2. The application for a centralised marketing authorisation of a veterinary medicinal product shall state a single name for the veterinary medicinal product to be used throughout the Union. |