Instructions for companies - Evidence submission to the Danish Medicines Council (DMC) for new pharmaceuticals or indications

Aug 31, 2026

Submission instructions for companies preparing evidence for the Danish Medicines Council (DMC) as part of the appraisal process for a new pharmaceutical or a new indication for an existing product. 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.

LanguageEnglish

CategoryForms

FormatDOCX

Pages79

Reading Time28 min

AccessFree to download

Documentation to be submitted

Application versions (Day 0 and later)

Confidential information

About macros in Excel

Version log

Contact information

Table of contents

Regulatory information on the pharmaceutical

Summary table

Patient population, intervention, comparator(s) and outcomes

Health economic analysis

Overview of literature

Efficacy

Version 2.0 Version 2.0 Instructions for companies This 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. Please note the following requirements: When preparing their application, companies must adhere to the current version of the DMC’s HYPERLINK "https://medicinraadet.dk/media/5eibukbr/the-danish-medicines-council-methods-guide-for-assessing-new-pharmaceuticals-version-1-3.pdf" methods guide, in addition to using the current version of this template. Headings, subheadings and appendices must not be removed. Tables must not be edited, unless it is explicitly stated in the text. Text in grey and [in brackets] is only for example purposes and must be deleted. All 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. The main body of the application must not be longer than 100 pages, excluding appendices. The formatting is not to be altered and all cross-references must work. All applications must comply with the general data protection regulations, find more information on DMC’s data policy HYPERLINK "https://medicinraadet.dk/om-os/medicinradets-persondatapolitik" here. Submissions in either Danish or English are accepted. The assessment process cannot be initiated before all the requirements are met. Documentation to be submitted The following documentation must be sent to the DMC’s email medicinraadet@medicinraadet.dk: Application in word format* Application in PDF format* Health 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 HYPERLINK "https://medicinraadet.dk/ansogning" \h DMC's website. The European Public Assessment Report (EPAR) should be submitted as soon as possible (draft versions will be accepted). * 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). Confidential information In 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”. About macros in Excel Due 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 HYPERLINK "https://medicinraadet.dk/ansogning/sikkerhedskrav-til-ansogninger" here. Version log Application for the assessment of for Contact information [If a company wishes to use external representation in relation to the application for evaluation of a new pharmaceutical / extension of indications, the following HYPERLINK "https://medicinraadet.dk/media/u35diqaa/fuldmagt-anvendelse-af-ekstern-repraesentation.pdf" power of attorney must be completed and sent to HYPERLINK "mailto:medicinraadet@medicinraadet.dk" \t "_blank" medicinraadet@medicinraadet.dk.] Table of contents TOC \o "1-5" \h \z \u HYPERLINK \l "_Toc144297555" Instructions for companies PAGEREF _Toc144297555 \h 1 HYPERLINK \l "_Toc144297556" Version log PAGEREF _Toc144297556 \h 1 HYPERLINK \l "_Toc144297557" Contact information PAGEREF _Toc144297557 \h 2 HYPERLINK \l "_Toc144297558" Tables and Figures PAGEREF _Toc144297558 \h 6 HYPERLINK \l "_Toc144297559" Abbreviations PAGEREF _Toc144297559 \h 6 HYPERLINK \l "_Toc144297560" 1. Regulatory information on the pharmaceutical PAGEREF _Toc144297560 \h 7 HYPERLINK \l "_Toc144297561"

FAQs

What requirements must companies follow when preparing the DMC submission?

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.

What documentation must be sent to the DMC, and in which formats?

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.

How should confidentiality be handled in the submission materials?

Confidential information must be highlighted in yellow, and confidential appendices must be watermarked “confidential.” The expected publication date should be provided when applicable.

What are the Excel macro submission requirements?

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.

Aug 31, 2026

Upload by Felix Montgomery