Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 supplementing Re... (32021R0578)
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 (Text with EEA relevance)
- 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
- (Text with EEA relevance)
- CHAPTER I
- Article 1
- Veterinary antimicrobial medicinal products for which data on the volume of sales shall be collected and reported to the Agency
- Article 2
- Veterinary antimicrobial medicinal products for which data on the volume of sales may be collected and reported to the Agency
- Article 3
- Antimicrobial medicinal products for which data on use shall be collected and reported to the Agency
- Article 4
- Antimicrobial medicinal products for which data on use may be collected and reported to the Agency
- Article 5
- Classification systems for the identification of antimicrobial medicinal products for which data shall be collected and reported to the Agency
- CHAPTER II
- Article 6
- Data quality requirements
- Article 7
- Data quality management plan, national contact point and data managers
- Article 8
- Protocols and templates for data reporting by Member States
- Article 9
- Assistance to Member States on data quality management
- Article 10
- Web interface for collated data reporting by Member Sates
- CHAPTER III
- Article 11
- Methods for collecting data on the volume of sales of veterinary antimicrobial medicinal products
- Article 12
- Methods for reporting to the Agency data on the volume of sales of veterinary antimicrobial medicinal products
- Article 13
- Methods for collecting and reporting to the Agency data on the use of antimicrobial medicinal products
- Article 14
- Systems for the collection of data on the use of antimicrobial medicinal products
- Article 15
- Animal species, categories and stages thereof, for which data on the use of antimicrobial medicinal products shall be collected and reported
- Article 16
- 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 17
- 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 18
- Entry into force and application
- ANNEX
- 1.
- 2.
- 3.
- 4.
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