[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-252614-105":53,"doc-detail-252614-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","preparation-of-esuavet-annual-reports-standard-operating-procedure","Preparation of ESUAvet annual reports - Standard Operating Procedure","","This SOP standardizes the end-to-end preparation and publication workflow for the ESUAvet annual reporting cycle, covering governance, planning, data submission by Member States, and subsequent validation, analysis, drafting, production, review, endorsement, adoption, publication, and post-publication follow-up. The procedure relies on antimicrobial veterinary medicinal product sales and antimicrobial use data for the preceding calendar year, submitted under Article 57 of Regulation (EU) 2019/6. It ensures outputs align with the legal mandate, scientific standards, and EMA quality and editorial requirements.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/preparation-of-esuavet-annual-reports-standard-operating-procedure/252614/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/preparation-of-esuavet-annual-reports-standard-operating-procedure/252614.png","ImageObject",442,249,{"name":88,"@type":89},"Eden","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-31","2026-09-13",true,{"@type":98,"interactionType":99,"userInteractionCount":20},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What does the SOP cover for the ESUAvet annual reporting cycle?","Question",{"text":108,"@type":109},"It covers the end-to-end process from governance and planning through Member State data submission, validation, analysis, drafting and production, review and consultation, endorsement, adoption, publication, and post-publication follow-up.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Which data sources and reporting period does the SOP require?",{"text":113,"@type":109},"The SOP requires antimicrobial veterinary medicinal product sales and antimicrobial use data for the preceding calendar year, reported by Member States to the Agency under Article 57 of Regulation (EU) 2019/6.",{"name":115,"@type":106,"acceptedAnswer":116},"Who is responsible for ensuring the procedure is followed?",{"text":117,"@type":109},"The Head of V-SR-AMR ensures adherence to the procedure, with step-by-step roles further detailed under section 9.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},252614,1790001926,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":20,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":47,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":139,"read_time":73},1374391974468,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","Standard operating procedure  \n\n| Title: Preparation of ESUAvet annual reports |  |  |\n| --- | --- | --- |\n| Status: PUBLIC |  | Document no.: SOP/V/4160 |\n| Lead author | Approver | Effective date: 30-APR-26 |\n| Name: on file | Name: on file | Review date: 30-APR-29 |\n| Signature: on file | Signature: on file | Supersedes: N/A |\n| Date: 30.04.2026 | Date: 30.04.2026 | DREAM no.: EMA/25640/2026 |\n\n1. Purpose  \nThis SOP covers the preparation of the ESUAvet annual report based on antimicrobial veterinary medicinal product (VMP) sales and antimicrobial use data for the preceding calendar year, reported by Member States to the Agency under the framework of Article 57 of Regulation (EU) 2019/6 , describing the end-to-end process for the preparation and publication of the annual ESUAvet reporting cycle, from governance and planning through data submission by Member States (MSs) , validation, analysis, report drafting and production, review and consultation, endorsement, adoption, publication, and post‑publication follow‑up.  \nIt provides a structured and consistent framework to ensure that the report is produced in line with the legal mandate, scientific standards, and EMA quality and editorial requirements.  \n2. Scope  \nThis SOP applies to staff in the Veterinary Antimicrobial Monitoring and Resistance Service (V-SR-AMR) of the Surveillance and Regulatory Support (V-SR) department.  \n3. Responsibilities  \nIt is the responsibility of the Head of V-SR-AMR to ensure that this procedure is adhered to. The roles responsible for each step are further detailed under section 9.  \n4. Changes since last revision  \nNew SOP.  \n5. Documents needed for this SOP  \n• EMA editorial and publication guidance (EMA/39139/2026)  \n• Antimicrobial Sales and Use Platform | European Medicines Agency (EMA)  \n• Guideline on the reporting of antimicrobial sales and use in animals at the EU level – denominatorsand indicators (EMA/CVMP/882931/2022)  \n6. Related documents  \n• 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  \n• 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  \n• 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  \n7. Definitions  \nAdoption Formal acceptance of the annual ESUAvet report by the CVMP in  \naccordance with its procedures  \nCVMP Committee for Veterinary Medicinal Products  \nEMA European Medicines Agency  \nESUAvet European Sales and Use of Antimicrobials for Veterinary Medicine  \nESUAvet Working Group (WG) CVMP Working Group supporting the Agency in the scientific  \npreparation and review of ESUAvet outputs. All Member States that collect and report to EMA data under Article 57 of Regulation (EU) 2019/6 have nominated members in the WG.  \nHDep Head of Department (in Veterinary Surveillance and Regulatory  \nSupport)  \nHDiv Head of (Veterinary Medicines) Division HSer Head of Service (in V-SR-AMR)  \nMS Member State of the European Union and European Economic Area,  \nplus Northern Ireland  \nSL EMA Scientific Lead in V-SR-AMR  \nV-SR Surveillance and Regulatory Support department in Veterinary  \nMedicines Division  \nV-SR-AMR Veterinary Antimicrobial Monitoring and Resistance Service in V-SR  \n9. Procedure  \n\n| Step | Action | Responsibility |\n| --- | --- | --- |\n| 1 | Planning & receipt of data submissions |  |\n| 1.1 | In Q1 of each year:\u003Cbr>Establish the framework for the reporting cycle, including how the legally defined scope is ","cbCaic9ggzHhm0D0","https://ap.wps.com/l/cbCaic9ggzHhm0D0","pdf",288885,"English","# Purpose\n# Scope\n# Responsibilities\n# Changes since last revision\n# Documents needed for this SOP\n# Related documents\n# Definitions\n# Procedure\n## Step 1: Planning & receipt of data submissions\n## Step 2: Annual report drafting & review","[{\"question\":\"What does the SOP cover for the ESUAvet annual reporting cycle?\",\"answer\":\"It covers the end-to-end process from governance and planning through Member State data submission, validation, analysis, drafting and production, review and consultation, endorsement, adoption, publication, and post-publication follow-up.\"},{\"question\":\"Which data sources and reporting period does the SOP require?\",\"answer\":\"The SOP requires antimicrobial veterinary medicinal product sales and antimicrobial use data for the preceding calendar year, reported by Member States to the Agency under Article 57 of Regulation (EU) 2019/6.\"},{\"question\":\"Who is responsible for ensuring the procedure is followed?\",\"answer\":\"The Head of V-SR-AMR ensures adherence to the procedure, with step-by-step roles further detailed under section 9.\"}]","Preparation of ESUAvet annual reports - Standard Operating Procedure | PDF",1789262184]