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The template sets compliance requirements for the DMC methods guide, forbids editing tables unless stated, and requires every section to be completed with N/A where applicable. It specifies page limits, formatting and cross-reference rules, data protection compliance, confidential information handling, and Excel macro security. It also defines the documentation package, including word/PDF versions and an Excel health economic model with full code access.",{"@graph":63,"@context":122},[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":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/instructions-for-companies-evidence-submission-to-the-danish-medicines-council-dmc-for-new-pharmaceuticals-or-indications/164048/",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/instructions-for-companies-evidence-submission-to-the-danish-medicines-council-dmc-for-new-pharmaceuticals-or-indications/164048.png","ImageObject",442,249,{"name":88,"@type":89},"Felix Montgomery","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-22","2026-08-31",true,{"@type":98,"interactionType":99,"userInteractionCount":73},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114,118],{"name":105,"@type":106,"acceptedAnswer":107},"What requirements must companies follow when preparing the DMC submission?","Question",{"text":108,"@type":109},"Companies must comply with the current DMC methods guide in addition to the current template. Headings, subheadings and appendices must remain, tables must not be edited unless explicitly allowed, and all cross-references must work.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What documentation must be sent to the DMC, and in which formats?",{"text":113,"@type":109},"Submit the application in Word and PDF formats. Include a health economic model (budget impact model) in one Excel file with full programming code access, and provide the EPAR as soon as possible.",{"name":115,"@type":106,"acceptedAnswer":116},"How should confidentiality be handled in the submission materials?",{"text":117,"@type":109},"Confidential information must be highlighted in yellow, and confidential appendices must be watermarked “confidential.” The expected publication date should be provided when applicable.",{"name":119,"@type":106,"acceptedAnswer":120},"What are the Excel macro submission requirements?",{"text":121,"@type":109},"Excel files containing macros must be authorized and signed by the applicant before submission to the DMC, in line with the stated IT security requirements.","https://schema.org",{"og:url":78,"og:type":124,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":126,"canonical":78},"index,follow",{"doc_id":128,"site_id":56},164048,1790119613,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":88,"user_avatar":133,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":73,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":139,"language":140,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":61,"update_tm":144,"read_time":145},549768064778,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","Version 2.0\nVersion 2.0\nInstructions for companies\nThis is the template for submitting evidence to the Danish Medicines Council (DMC) as part of the appraisal process for a new pharmaceutical or a new indication for an existing pharmaceutical. The template is not exhaustive.\nPlease note the following requirements:\nWhen preparing their application, companies must adhere to the current version of the DMC’s \u0013 HYPERLINK \"https://medicinraadet.dk/media/5eibukbr/the-danish-medicines-council-methods-guide-for-assessing-new-pharmaceuticals-version-1-3.pdf\" \u0014methods guide\u0015, in addition to using the current version of this template.\nHeadings, subheadings and appendices must not be removed. Tables must not be edited, unless it is explicitly stated in the text.\nText in grey and [in brackets] is only for example purposes and must be deleted.\nAll sections in the template must be filled in. If a section or an appendix is not applicable, state “not applicable” (N/A) and explain why.\nThe main body of the application must not be longer than 100 pages, excluding appendices.\nThe formatting is not to be altered and all cross-references must work.\nAll applications must comply with the general data protection regulations, find more information on DMC’s data policy \u0013 HYPERLINK \"https://medicinraadet.dk/om-os/medicinradets-persondatapolitik\" \u0014here\u0015.\nSubmissions in either Danish or English are accepted.\nThe assessment process cannot be initiated before all the requirements are met.\nDocumentation to be submitted\nThe following documentation must be sent to the DMC’s email medicinraadet@medicinraadet.dk:\nApplication in word format*\nApplication in PDF format*\nHealth economic model including budget impact model in one Excel file, with full access to the programming code. The model must include relevant sheets from the DMC Excel template ‘Key figures including general mortality’ available on the \u0013 HYPERLINK \"https://medicinraadet.dk/ansogning\" \\h \u0014DMC's website\u0015.\nThe European Public Assessment Report (EPAR) should be submitted as soon as possible (draft versions will be accepted).\n* Later in the appraisal process, once the application has received Day 0, the application must be assembled and sent to the DMC in one blinded version and one highlighted version (both in word and pdf).\nConfidential information\nIn the preparation of the documentation, companies must ensure that all confidential information is highlighted in yellow and provide the expected date of publication, if applicable. If confidential appendices are provided, these must be watermarked as “confidential”.\nAbout macros in Excel\nDue to IT security requirements, Excel files containing macros must be authorized and signed by the applicant before being submitted to the DMC. Find more information \u0013 HYPERLINK \"https://medicinraadet.dk/ansogning/sikkerhedskrav-til-ansogninger\" \u0014here\u0015.\nVersion log\nApplication for the assessment of \u003Cproprietary name of pharmaceutical> for \u003Cindication>\n\u000f\nContact information\n[If a company wishes to use external representation in relation to the application for evaluation of a new pharmaceutical / extension of indications, the following \u0013 HYPERLINK \"https://medicinraadet.dk/media/u35diqaa/fuldmagt-anvendelse-af-ekstern-repraesentation.pdf\" \u0014power of attorney\u0015 must be completed and sent to \u0013 HYPERLINK \"mailto:medicinraadet@medicinraadet.dk\" \\t \"_blank\" \u0014medicinraadet@medicinraadet.dk\u0015.]\n\u000f\nTable of contents\n\u0013 TOC \\o \"1-5\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc144297555\" \u0014Instructions for companies\t\u0013 PAGEREF _Toc144297555 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc144297556\" \u0014Version log\t\u0013 PAGEREF _Toc144297556 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc144297557\" \u0014Contact information\t\u0013 PAGEREF _Toc144297557 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc144297558\" \u0014Tables and Figures\t\u0013 PAGEREF _Toc144297558 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc144297559\" \u0014Abbreviations\t\u0013 PAGEREF _Toc144297559 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc144297560\" \u00141.\tRegulatory information on the pharmaceutical\t\u0013 PAGEREF _Toc144297560 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc144297561\"","cbCaisUUDAkBAkh9","https://ap.wps.com/l/cbCaisUUDAkBAkh9","docx",312193,79,"English","# Documentation to be submitted\n## Application versions (Day 0 and later)\n# Confidential information\n# About macros in Excel\n# Version log\n# Contact information\n# Table of contents\n## Regulatory information on the pharmaceutical\n## Summary table\n## Patient population, intervention, comparator(s) and outcomes\n## Health economic analysis\n## Overview of literature\n## Efficacy","[{\"question\":\"What requirements must companies follow when preparing the DMC submission?\",\"answer\":\"Companies must comply with the current DMC methods guide in addition to the current template. Headings, subheadings and appendices must remain, tables must not be edited unless explicitly allowed, and all cross-references must work.\"},{\"question\":\"What documentation must be sent to the DMC, and in which formats?\",\"answer\":\"Submit the application in Word and PDF formats. Include a health economic model (budget impact model) in one Excel file with full programming code access, and provide the EPAR as soon as possible.\"},{\"question\":\"How should confidentiality be handled in the submission materials?\",\"answer\":\"Confidential information must be highlighted in yellow, and confidential appendices must be watermarked “confidential.” The expected publication date should be provided when applicable.\"},{\"question\":\"What are the Excel macro submission requirements?\",\"answer\":\"Excel files containing macros must be authorized and signed by the applicant before submission to the DMC, in line with the stated IT security requirements.\"}]","Instructions for companies - Evidence submission to the Danish Medicines Council (DMC) for new pharmaceuticals or indications | DOCX",1788149232,28]