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Commission Delegated Regulation (EU) 2021/578 SECTION 2 — Data on the use

Article 13–Article 15 · 3 articles

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

Methods for collecting and reporting to the Agency data on the use of antimicrobial medicinal products

Article 13

1.   In order to facilitate the collection of standardised and harmonised data on the use of the antimicrobial medicinal products referred to in Articles 3 and 4, Member States shall collect those data: (a) from the following data providers, as appropriate: veterinarians, retailers, pharmacies, feed mills and end-users, including farmers or breeders; (b) based on the following data sources, as appropriate: health records, treatment logbooks, delivery notes, invoices from farms, prescriptions, pharmacy records or veterinary practice records; (c) using the systems for the collection of data on use referred to in Article 14. 2.   Member States shall report their data on the use of the relevant veterinary antimicrobial medicinal products and antimicrobial medicinal products for human use, which may exceptionally be used in animals, for each product presentation, and for relevant animal species, categories or stages described in Article 15. They shall ensure that the data cover all uses of the relevant antimicrobial medicinal products during the preceding calendar year within their respective Member State territories, in line with Article 6(e). The first report shall be sent to the Agency by 30 September 2024 and shall cover the data of antimicrobial medicinal products used during the preceding calendar year for relevant animal species, categories or stages. The following reports after the first report shall be sent to the Agency by 30 June of each year and shall cover the data of antimicrobial medicinal products used during the preceding calendar year for relevant animal species, categories or stages. 3.   Member States shall report their data on the use of the relevant antimicrobials via the web interface, using the protocols and templates made available to this end by the Agency and taking account of other relevant guidance documents produced by the Agency. 4.   Member States shall also report the following information to the Agency, via their national contact points and data managers and using the web interface: (a) the type of data providers and data sources from which they collected their data on use, along with a short description of the main characteristics of their national systems for collection of data on use of antimicrobial medicinal products in animals; (b) the coverage and accuracy of their data on use, together with measures taken to avoid double reporting; (c) any initiatives led within the country or any relevant specific factors which may explain the results observed at national level, including possible pattern changes and trends; (d) a brief description of their national policy framework or main initiatives in place to fight antimicrobial resistance and reduce any use of antimicrobials in animals that is neither prudent nor responsible. 5.   Member States shall provide the information described in paragraph 4 for the first data report by 30 September 2024 and update it subsequently in the following reporting periods, as applicable.

Systems for the collection of data on the use of antimicrobial medicinal products

Article 14

1.   Member Sates shall develop semi- or fully-automated continuous data collection systems in order to gather data on the use of antimicrobial medicinal products in animals. 2.   Member States shall develop software solutions to facilitate such data collection and support quality assurance, validation and quality control. 3.   Taking into account the diversity of practices across the Union and the differences in national legal contexts, the Agency together with Member States shall organise, as appropriate, best practice sharing activities to support Member States in the development of their systems for collection of data on use. 4.   Member States shall organise regular training sessions, or other information campaigns, for data providers on how to report data on the use of antimicrobials in animals via their respective national data collection systems.

Animal species, categories and stages thereof, for which data on the use of antimicrobial medicinal products shall be collected and reported

Article 15

1.   Member States shall collect data on use for the following food-producing animal species, including all categories and stages, and report the data yearly to the Agency starting from 30 September 2024: (a) cattle, while distinguishing beef cattle from dairy cattle and specifying use in bovines under one year of age separately when the production of meat from slaughtered bovines under one year of age exceeds 10 000 tonnes per year; (b) pigs, while specifying use in fattening pigs; (c) chicken, while specifying use in broilers and in laying hens; (d) turkeys, while specifying use in fattening turkeys. 2.   Member States shall collect data on use for the following food-producing animal species, including all categories and stages, and report the data yearly to the Agency starting from 30 June 2027: (a) other poultry (ducks, geese); (b) sheep; (c) goats; (d) finfish (Atlantic salmon, Rainbow trout, Gilthead seabream, European seabass, Common carp); (e) horses (including ones declared as not being intended for slaughter for human consumption in the single lifetime identification document referred to in Article 114(1)(c) of Regulation (EU) 2016/429 of the European Parliament and of the Council  ( 7 ) ); (f) rabbits (food-producing); (g) any other food-producing animals of relevance to them. 3.   Member States shall collect data on use for the following non-food-producing animal species, and report the data yearly to the Agency starting from 30 June 2030: (a) dogs; (b) cats; (c) fur animals (minks and foxes).

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