Application for marketing authorisation
8 March 2023: This page has been updated with a new subsection with the heading "Pilot study in 2023 with submission of bioequivalence study data in CDISC format".
Application guidelines
Guidelines for applicants for marketing authorisations for medicines
Bioequivalence and labelling of medicinal products with regard to generic substitution
Guidance to manufacturers outside the EU/EEA area
Guidelines for marketing authorisation for vitamin and mineral products
Forms
Information about completion of applicant, contact person and representative in the application form
The EU application form for a marketing authorisation of a homeopathic medicinal product (human use)
From September 1, 2025 the Danish Medicines Agency will request submission of bioequivalence data in CDISC format
During 2023 and 2024 the Danish Medicines Agency conducted a pilot study in which we explored how bioequivalence data in CDISC format (Clinical Data Interchange Standards Consortium format) could be used to assess the bioequivalence studies included in abridged applications. Based on the experiences from the pilot study, we have decided that clinical data in CDISC format should be used routinely in the assessment of marketing authorisation applications and variations. The use of clinical data in CDISC format can among other things be used to better qualify questions raised by the Danish Medicines Agency in the assessment. In this way, the new initiative can become a reduction of burden for applicants and marketing authorisation holders.
For applications submitted from September 1, 2025, including one or more bioequivalence studies, the Danish Medicines Agency will request bioequivalence data to be submitted in CDISC format. This applies to all purely national applications and to DCP and MRP procedures with Denmark as Reference Member State (RMS), including variations, and it applies regardless of the legal basis.
The bioequivalence data in CDISC-format should be submitted as working documents. In DCP and MRP applications the data in CDISC format should be submitted also to the concerned member states (CMS).
The submitted CDISC-data must meet the following:
- File format: SAS Transport Format (XPORT) Version 5, Adobe Portable Document Format (pdf), Extensible Markup Language (xml)
- Data standards: CDISC SDTM 1.2 or higher is requested. ADaM + programming statements for creation of ADaM data sets and analysis output (optional) including SDTMIG & define.xml
If necessary, the homepage CDISC.org can be consulted for further information.