Commission Implementing Regulation (EU) 2022/209 of 16 February 2022 establishing the format of the data to be collected and reported in order to determine the volume of sales and the use of antimicrobial medicinal products in animals in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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 (1), and in particular Article 57(4) thereof,

Whereas:

(1) Commission Delegated Regulation (EU) 2021/578 (2) sets out the requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals.

(2) In order for Member States to be able to collect and report such data to the European Medicines Agency (‘the Agency’), the format of such data should be clearly defined.

(3) The required format of the data should apply to the data collected for the antimicrobials referred to in Articles 1 to 4 of Delegated Regulation (EU) 2021/578 in order to have harmonised and comparable data. The required format of the data should equally apply to data collected on antimicrobials contained in medicated feed and intermediate products, in line with Article 4(4) of Regulation (EU) 2019/4 of the European Parliament and of the Council (3).

(4) The format, which Member States are to use for reporting antimicrobial sales and use data to the Agency, should take into account specific data variables that need to be provided per product presentation in order to enable the Agency to calculate the quantity of antimicrobial active substances from veterinary medicinal products sold per Member State for use on its territory during the year of data collection. Those data variables should also enable the Agency to calculate the quantity of antimicrobial active substances from medicinal products used in designated animal species or categories per Member State on its territory during the year of data collection. Additional data variables should be provided by Member States to the Agency, per reporting year, in order to allow for an accurate analysis and interpretation of the data.

(5) The Agency should provide the necessary supporting information to Member States in order to facilitate the harmonised calculation of the volume of sales and of the use of antimicrobials and to facilitate subsequent data validation by Member States before reporting to the Agency. Such supporting information is to be provided to Member States by the Agency through the web interface for collated data reporting referred to in Article 10 of Delegated Regulation (EU) 2021/578.

(6) In addition, the Agency should minimise the efforts required by Member States to enter data in the web interface, by pre-filling data entry fields whenever data is already available from existing databases under the remit of the Agency. At the same time, in line with Article 6 of Delegated Regulation (EU) 2021/578, Member States remain responsible for the fulfilment of the data quality requirements with respect to the information provided on the antimicrobial medicinal products authorised at national level, including the accuracy of the information provided by the Agency in those pre-filled data entry fields.

(7) To ensure that the data collected on the sales and the use of antimicrobials is comparable year-over-year within Member States and within the Union and that those data are adequately analysed, the format for reporting of the data should take into account the size of the animal population that is likely to be treated with antimicrobials. This should also facilitate the comparison of data reported at national level and at Union level with data available from non-Union countries and at global level. It is therefore important to define the format according to which the animal population data should be referred to. Any comparison of data across Member States should take into account the diversity of practices within the Union and the differences in national legal contexts.

(8) The most appropriate format for the animal population data as regards terrestrial animals should be the number of living animals or the number of slaughtered animals, depending on the animals species or categories concerned, while the most appropriate format for the animal population data as regards farmed fish should be the produced biomass. However, in order to appropriately reflect each Member State’s animal population data in the context of the collection of data on the volume of sales and on the use of antimicrobials in animals, so that it can be effectively used by the Agency, the animal population data should be adjusted according to so-called denominators, such as the population correction unit or other denominators, as appropriate. Such adjustments are necessary for the Agency to identify trends in the volume of sales and the use of antimicrobials in animals and make relevant analyses.

(9) This Regulation is necessary for the application of Regulation (EU) 2019/6, which applies from 28 January 2022. Therefore, and in accordance with Article 153(1) of Regulation (EU) 2019/6, this Regulation should apply from that same date.

(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products referred to in Article 145 of Regulation (EU) 2019/6,

HAS ADOPTED THIS REGULATION:

Article 1

Data to be reported to the Agency on the volume of sales of veterinary antimicrobial medicinal products

Article 2

Data to be reported to the Agency on the use of antimicrobial medicinal products in animals

Article 3

Information to be provided by the Agency for calculation and validation purposes

When providing the information necessary for the purposes of calculating the volume of sales and of the use of antimicrobials and validating data, the Agency shall use the variables specified in Annex III.

Article 4

Animal population data

(a) for terrestrial animals: the number of animals per year (living animals or slaughtered animals, depending on the animal species or categories concerned, as specified in the Agency’s protocols and templates for the reporting of data);

(b) for farmed fish: the biomass produced per year (live weight at slaughter).

Article 5

Adjustments to the animal population data for analysis purposes

Article 6

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 16 February 2022.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 4, 7.1.2019, p. 43.

(2) Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council with regard to requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals (OJ L 123, 9.4.2021, p. 7).

(3) Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1).