9 March 2021 EMA/210691/2015 Rev. 4 Veterinary Medicines Division European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) Sales Data and Animal Population Data Reporting Protocol (version 4) Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us An agency of the European Union Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. Table of content 1. Introduction ............................................................................................ 3 1.1. Terms of reference ............................................................................................. 3 1.2. Approach .......................................................................................................... 4 1.3. Organization of the project .................................................................................. 4 1.4. ESVAC web-based application .............................................................................. 5 2. ESVAC sales data ..................................................................................... 5 2.1. Selection of data source ...................................................................................... 5 2.2. Antimicrobial substances used in veterinary medicine to be included in sales dataset ... 6 2.3. Variables to be collected for each VMP presentation ................................................ 6 2.3.1. Conversion factors when strength is given in IU ................................................. 11 2.3.2. Conversion factors of certain derivatives or compounds ...................................... 12 3. Call for data ........................................................................................... 13 4. Filling in the sales template ................................................................... 13 4.1. General considerations ...................................................................................... 13 4.2. Comments on the various fields’ components ....................................................... 14 5. Data quality check ................................................................................. 16 5.1. Validating the sales data prior to the submission to the Agency .............................. 16 6. Animal population data. Calculation of PCU ........................................... 19 6.1. Animal categories included in PCU ...................................................................... 19 6.2. Calculation of PCU ............................................................................................ 21 7. Information required in addition to sales data ...................................... 22 8. Indicator for reporting of the sales data ................................................ 23 9. Confidentiality and security of submitted sales data ............................. 23 ANNEX 1 .................................................................................................... 24 1. Additional information for checking data quality ................................... 24 1.1. Validation of data ............................................................................................. 24 1.2. Cross-checking of sales data (supplementary information to section 5) .................... 24 1.3. Rules for reporting of qualitative and quantitative composition of antimicrobial VMPs (variable strength) .................................................................................................. 25 ANNEX 2 .................................................................................................... 31 2. Background information about ESVAC conversion factors ..................... 31 2.1. ESVAC conversion factors when strength is given in IU .......................................... 31 2.2. ESVAC derivative conversion factors ................................................................... 39 European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) Sales Data and Animal Population Data Reporting Protocol (version 4) Page 2/42 EMA/210691/2015-Rev.4 1. Introduction 1.1. Terms of reference In 2009 the European Commission requested the European Medicines Agency to take the lead in collating data on the use of antimicrobial agents in animals in the European Union and to manage the database. The European Medicines Agency (hereinafter referred to as the Agency) was asked to develop a harmonised approach for the collection and reporting of data based on national sales figures as well as data on usage in at least major groups of animal species and to ensure comparability with the sales of antimicrobial agents in human medicine. Current ESVAC activity should be aligned to comply with requirements laid down in the Article 57 of the Regulation (EU) 2019/6 on veterinary medicinal products. Until the new requirements are implemented, it is advised that the antimicrobial consumption data should be reported as outlined in the latest version of the ESVAC sales data and animal population data reporting protocol. The collection of data on sales of antimicrobial veterinary medicinal products (VMP), both at national and community level, may serve multiple purposes, of which the most important are the following: • to support the interpretation of patterns and trends of antimicrobial resistance (AMR); • to inform risk profiling and risk assessments regarding AMR; • to identify risk management priorities; • to support the evaluation of the effectiveness of control measures being implemented; • to quantify the use of specific classes of antimicrobial VMPs such as those included in Category B of the categorisation made by the EMA Antimicrobial Advice ad hoc Expert Group (AMEG) in 20191, which also takes into consideration those identified by World Health Organisation (WHO) as critically important for human medicine2; • to facilitate comparison of volume of sales of antimicrobial VMPs within and between time periods; • to identify focused and targeted research and development needs; • to support the integrated analysis of the consumption of antimicrobial agents and the occurrence of antimicrobial resistance in bacteria from humans and food-producing animals. This protocol addresses collection of sales data and data on animal population. The revision of the ESVAC sales and animal population data reporting protocol includes updates to ESVAC conversion factors and the introduction of the following new sections: section 7 with information required in addition to sales data (questionnaire), section 1.3. of Annex 1 on the reporting of qualitative and quantitative composition of antimicrobial VMPs, including examples of recording of the “STRENGTH” variable, and Annex 2 with background information about updated ESVAC conversion factors. The revision also includes several editorial updates to align the terminology used. 1 EMA/AMEG 2019. Categorisation of antibiotics in the European Union. Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals (https://www.ema. europa.eu/en/documents/report/categorisation-antibiotics-european-union-answer-request- european-commission-updating-scientific_ en.pdf) 2 WHO Critically important antimicrobials for human medicine, 6th revision (https://www.who.int/foodsafety/publications/antimicrobialssixth/en/) European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) Sales Data and Animal Population Data Reporting Protocol (version 4) Page 3/42 EMA/210691/2015-Rev.4 1.2. Approach To enable reliable data reporting, as well as comparison within and between time periods, standardisation and harmonization of data is of vital importance. This also applies for the animal demographic data that are used to normalise the sales data for reporting of the antimicrobial sales per each country. In ESVAC, a population correction unit (PCU) is used as the denominator and this represents purely a technical unit of measurement. The data sources used and the methodology for the calculation of PCU are comprehensively described in Appendix 2 of the Agency's report 'Trends in the sales of veterinary antimicrobial agents in nine European countries: 2005-2009' (EMA/238630/2011)3. In order to obtain reliable and harmonised data in the ESVAC database, all items in the data reporting package must be adhered to: • ESVAC sales and animal population data reporting protocol (ESVAC protocol); • ESVAC data reporting form (sales template); • ESVAC animal population reporting form, available on the ESVAC web-based application; • questionnaire to gather key information such as types of data and data sources, available through the ESVAC web-based application. 1.3. Organization of the project The ESVAC project is organised into three main work streams: collection of sales data, collection of data on use by animal species and establishment of technical units of measurement. Separate expert groups are established for these three work streams. The organisation of the ESVAC project is illustrated in Figure 1. The ESVAC National Contact Points (NCs) and/or Data Managers (DMs) are responsible for collecting, validating, submitting sales data and for validating the PCU data uploaded by the Agency. 3 Available from the Agency's website via: Home > Regulatory > Veterinary medicines