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Covers mandatory fields (procedure details, product identifiers, marketing authorisation holder, and international non-proprietary name), rapporteur instructions on completing actual circulation dates, and criteria for PRAC/CHMP plenary discussions and potential RfSI timetable. Includes guidance on declarations, sections for non-interventional PASS, risk management plan components, benefit-risk balance conclusions, and required updates to the joint report and product information for comments.",{"@graph":63,"@context":119},[64,80,102],{"@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/annual-re-assessment-assessment-report-template-joint-chmp-prac-rapporteur-ar/178032/",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/annual-re-assessment-assessment-report-template-joint-chmp-prac-rapporteur-ar/178032.png","ImageObject",442,249,{"name":88,"@type":89},"Arica Lee","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-27","2026-09-02",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",10,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What information must be completed in the annual re-assessment assessment report template?","Question",{"text":109,"@type":110},"The template requires procedure details (including procedure number and actual stage dates), product identifiers (product name, EMEA/H/C reference, international non-proprietary name), and the marketing authorisation holder (MAH). It also includes fields for rapporteur instructions, comments timelines, and declarations for the relevant assessment aspects.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"How are PRAC/CHMP plenary discussion criteria defined in the template?",{"text":114,"@type":110},"Criteria include interim results from the SOB/Non-interventional PASS outcomes challenging the benefit-risk balance, new imposed Non-interventional PASS linked to the annual re-assessment (annex II condition), and divergent committee positions with significant impact on benefit-risk. The CHMP criteria also require fulfilment of all SOBs.",{"name":116,"@type":107,"acceptedAnswer":117},"What timetable and update steps apply when issues cannot be resolved between D60 and D90?",{"text":118,"@type":110},"The template specifies that a defined RfSI timetable applies in rare cases where issues remain unresolved between D60-D90 and CHMP must adopt the RfSI. It also instructs when PRAC and CHMP rapporteurs must update relevant AR sections (risk management plan components and benefit-risk preliminary conclusions) and finalise the updated joint report after comments and discussions.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},178032,1791353928,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":141,"read_time":142},8796096645457,"https://ap-avatar.wpscdn.com/avatar/800003749518d68ffe3?x-image-process=image/resize,m_fixed,w_180,h_180&k=1779345340919836971","\u003CDoc. Ref.>\nAssessment report on the \u003C1st, 2nd, 3rd, etc.> annual re-assessment\n(Rapporteurs \u003Cpreliminary> \u003Cupdated> joint assessment report/Request for supplementary information)\nProcedure No:\nInvented name:\nInternational non-proprietary name:\nMarketing authorisation holder (MAH):\nNote to the Rapporteur/CHMP and PRAC members - send the joint report/comments\nTo: list-h-chmp@eudra.org; \u003Clist-h-pharmacovigilance@eudra.org;> Procedure.Manager@ema.europa.eu; Procedure.Assistant@ema.europa.eu\nCc: product name-XXXX@ema.europa.eu\nSubject for AR: Product name; EMEA/H/C/xxxxxx/R/xxxx Joint CHMP-PRAC Rapporteur AR - comments by {comments due date}\nSubject for comments: Product name; EMEA/H/C/xxxxxx/R/xxxx MS comments\n\u000f\nThe PRAC/CHMP Rapporteurs should complete the ‘actual’ date at each stage of the procedure. This is the date of circulation of the report to CHMP/PRAC members.\nIn a rare situation when the issues cannot be resolved between D60-D90 and the CHMP has to adopt the RfSI, the following timetable will apply:\n¹ Tick the box corresponding to the applicable step – do not delete any of the steps. If not applicable, add n/a instead of the date.\n² Criteria for PRAC plenary discussion: interim results/outcome of the SOB that is a non-interventional PASS study challenging the benefit/risk balance of the product; new imposed non-interventional PASS resulting from the Annual re-assessment (annex II condition); divergent positions between the Committees (CHMP and PRAC Rapp and CHMP and PRAC members) on specific aspects with significant impact on the B/R (e.g. outcome or imposition of conditions) and any other situation at the discretion of the PRAC rapporteur.\nCriteria for CHMP plenary discussion: interim results/outcome of the SOB challenging the benefit/risk balance of the product; fulfilment of all SOBs; new imposed PASS/PAES resulting from the Annual re-assessment (annex II condition); divergent positions between the Committees (CHMP and PRAC Rapp and CHMP and PRAC members) on specific aspects with significant impact on the B/R and any other situation at the discretion of the CHMP rapporteur.\n³ Sections related to data on non-interventional PASS imposed as an SOB, Risk Management Plan (safety concerns, pharmacovigilance plan, risk minimisation measures), sections on issues originating from parallel/recent PSUR or signal assessment, additional monitoring, pharmacovigilance inspections and preliminary conclusions on the benefit/risk balance.\u000f\nDeclarations\n(for Non-Clinical/Clinical/Pharmacovigilance aspects):\n\u0013 FORMCHECKBOX \u0014\u0015 (Non-Clinical/Clinical/Pharmacovigilance) The assessor confirms that reference to ongoing assessments or development plans for other products is not included in this assessment report.\nWhenever the above box is un-ticked please indicate section and page where confidential information is located here:\n\u000f\nGeneral guidance\nThe CHMP Rapporteur takes the lead for the finalisation of the report, i.e. Annual Re-Assessment is a CHMP-led procedure.\nThe PRAC Rapporteur should complete the parts relevant to them, if applicable, by Day 40.\nThe CHMP Rapporteur drafts their parts of the assessment and liaises with the PRAC Rapporteur by Day 55 at the latest, to finalise the joint report no later than Day 60.\nAny comments of the CHMP/PRAC Rapporteurs on the Product Information are to be included in this document and the product information is to be appended to the joint report when sending it out for comments.\nIn case of PRAC discussion:\nThe joint assessment report should be updated by the PRAC Rapporteur in the relevant sections of the AR (risk management plan: safety concerns, Pharmacovigilance plans, Risk minimisation Measures) and preliminary conclusions on the Benefit/risk balance), no later than Day 76.\nThe CHMP Rapporteur liaises with the PRAC Rapporteur to finalise the updated joint report following CHMP comments and PRAC discussion no later than Day 83.\n\u000f\nTable of contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc4834","cbCaiand1kW3C7sb","https://ap.wps.com/l/cbCaiand1kW3C7sb","docx",157477,25,"English","# 1. Background information on the annual re-assessment\n## 1.1. Declarations\n# 2. Overall conclusions and benefit-risk balance\n## 2.1. Specific Obligations (SOBs)\n## 2.2. Benefit-risk Balance\n# 3. Recommendations\n# 4. EPAR changes\n# Annex: Rapporteurs’ assessment comments on the annual re-assessment\n# 5. Specific Obligations\n## 5.1. Specific Obligations adopted with the initial Marketing Authorisation\n## 5.2. Outstanding Specific Obligations – status report for period covered\n## 5.3. Overall conclusion on Specific Obligations\n# 6. Risk management plan\n# 7. Changes to the Product Information\n# 8. Request for supplementary information (RfSI)\n## 8.1. Major objections\n## 8.2. Other concerns\n# 9. Assessment of the MAH responses RfSI\n## 9.1. Major objections\n## 9.2. Other concerns\n# 10. Attachment","[{\"question\":\"What information must be completed in the annual re-assessment assessment report template?\",\"answer\":\"The template requires procedure details (including procedure number and actual stage dates), product identifiers (product name, EMEA/H/C reference, international non-proprietary name), and the marketing authorisation holder (MAH). It also includes fields for rapporteur instructions, comments timelines, and declarations for the relevant assessment aspects.\"},{\"question\":\"How are PRAC/CHMP plenary discussion criteria defined in the template?\",\"answer\":\"Criteria include interim results from the SOB/Non-interventional PASS outcomes challenging the benefit-risk balance, new imposed Non-interventional PASS linked to the annual re-assessment (annex II condition), and divergent committee positions with significant impact on benefit-risk. The CHMP criteria also require fulfilment of all SOBs.\"},{\"question\":\"What timetable and update steps apply when issues cannot be resolved between D60 and D90?\",\"answer\":\"The template specifies that a defined RfSI timetable applies in rare cases where issues remain unresolved between D60-D90 and CHMP must adopt the RfSI. It also instructs when PRAC and CHMP rapporteurs must update relevant AR sections (risk management plan components and benefit-risk preliminary conclusions) and finalise the updated joint report after comments and discussions.\"}]","Annual Re-Assessment Assessment Report Template - Joint CHMP-PRAC Rapporteur AR | DOCX",1788330132,9]