EN
17.2.2022
Official Journal of the European Union
L 35/7
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.
(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).