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Commission Delegated Regulation (EU) 2021/578 SECTION 3 — Report by the Agency on the volume of sales and on the use

Article 16–Article 18 · 3 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Data and analyses to be included in the report by the Agency on the volume of sales of veterinary antimicrobial medicinal products and on the use of antimicrobial medicinal products

Article 16

1.   The Agency shall include in its report the data on the volume of sales of veterinary antimicrobial medicinal products and on the use of antimicrobial medicinal products per animal species, as referred to in Articles 12(2) and 13(2). 2.   The data included in the Agency’s report on the volume of sales of veterinary antimicrobial medicinal products shall be compared to the data of the preceding reporting periods, including data on the volume of sales reported under the ESVAC project, as appropriate and as far as the quality and the format of the data allows it. 3.   The data included in the Agency’s report on the use of antimicrobial medicinal products, starting from the second report to be published by 31 December 2025, shall be compared with the data of the preceding reporting periods. 4.   The Agency shall analyse the data on the volume of sales of veterinary antimicrobial medicinal products and on the use of antimicrobial medicinal products and identify trends and pattern changes over time, both at national and Union levels. Those analyses shall be carried out in cooperation with Member States and other Union agencies, as appropriate, and included with the identified trends and pattern changes in the Agency’s reports, together with the information provided by Member States as referred to in Article 12(3) and Article 13(4). 5.   The Agency shall consider relevant animal populations per Member State in its analyses of the national data on the volume of sales of veterinary antimicrobial medicinal products and on the use of antimicrobial medicinal products. To this end, the Agency shall identify the necessary data on relevant animal populations per Member State via publicly accessible existing Union databases and ask Member States to verify and validate them. In the event that the necessary data on relevant animal populations is not available in such Union databases, or that those data would not comply with the data quality requirements laid down in Article 6, the Agency shall require Member States to provide or amend such data via the web interface. 6.   For the reporting on the volume of sales of veterinary antimicrobial medicinal products, the Agency shall report the data for the corresponding animal populations likely to be treated with these products in the reporting Member States. The data shall be reported for food-producing animals and for other animals kept or bred, separately. 7.   For the reporting on the use of antimicrobial medicinal products, as regards food-producing species, if data on certain animal populations are not available at national level because of very low production levels, then data on use for those animal populations may be reported under the animal group referred to in Article 15(2)(g).

Publication by the Agency of its report on the volume of sales of veterinary antimicrobial medicinal products and on the use of antimicrobial medicinal products

Article 17

1.   The first report on the volume of sales of veterinary antimicrobial medicinal products and on the use of antimicrobial medicinal products per animal species shall be published by the Agency by 31 March 2025 and shall include the following: (a) the volume of sales of veterinary antimicrobial medicinal products, covering data from 2023 and submitted by Member States by 30 June 2024; (b) the use of antimicrobial medicinal products for relevant animal species, categories or stages covering data from 2023 and submitted by Member States by 30 September 2024. 2.   As from 2025, the following reports after the first report shall be published by the Agency by 31 December and shall include the following: (a) the volume of sales of veterinary antimicrobial medicinal products submitted by Member States by 30 June of each year, covering data from the preceding calendar year; (b) the use of antimicrobial medicinal products for relevant animal species, categories or stages submitted by Member States by 30 June of each year, covering data from the preceding calendar year.

Entry into force and application

Article 18

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 28 January 2022.

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