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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 57 CELEX: 02019R0006-20220128 Collection of data on antimicrobial medicinal products used in animals
1. Member States shall collect relevant and comparable data on the volume of sales and on the use of antimicrobial medicinal products used in animals, to enable in particular the direct or indirect evaluation of the use of such products in food-producing animals at farm level, in accordance with this Article and within the time limits set out in paragraph 5. 2. Member States shall send collated data on the volume of sales and the use per animal species and per types of antimicrobial medicinal products used in animals to the Agency in accordance with paragraph 5 and within the time limits referred to therein. The Agency shall cooperate with Member States and with other Union agencies to analyse those data and shall publish an annual report. The Agency shall take into account those data when adopting any relevant guidelines and recommendations. |
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 57 CELEX: 02019R0006-20220128 3. The Commission shall adopt delegated acts in accordance with Article 147, in order to supplement this Article, establishing the requirements as regards: (a) the types of antimicrobial medicinal products used in animals for which data shall be collected; (b) the quality assurance that Member States and the Agency shall put in place to ensure quality and comparability of data; and (c) the rules on the methods of gathering data on the use of the antimicrobial medicinal products used in animals and on the method of transfer of those data to the Agency. 4. The Commission shall, by means of implementing acts, set up the format for the data to be collected in accordance with this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). |
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 57 CELEX: 02019R0006-20220128 5. Member States shall be allowed to apply a progressive stepwise approach regarding the obligations set out in this Article so that: (a) within two years from 28 January 2022, data shall be collected at least for the species and categories included in Commission Implementing Decision 2013/652/EU () in its version of 11 December 2018; (b) within five years from 28 January 2022, data shall be collected for all food-producing animal species; (c) within eight years from 28 January 2022, data shall be collected for other animals which are bred or kept. 6. Nothing in point (c) of paragraph 5 shall be understood to include an obligation to collect data from natural persons keeping companion animals. |