Application for marketing authorisation

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

The European Commission's application forms (human and veterinary) for application for marketing authorisation

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)

Pilot study in 2023 and 2024 with submission of bioequivalence study data in CDISC format

The Danish Medicines Agency has initiated a pilot study with the scope of investigating how bioequivalence study data in CDISC format (Clinical Data Interchange Standards Consortium format) can be used to assess the bioequivalence studies included in abridged applications. The experiences from the pilot study will be used to evaluate whether the use of clinical data in CDISC format should be used routinely in connection with the assessment of marketing authorisation applications.

For a period from mid-March 2023, we will request applicants in selected applications via the Decentralised Procedure (DCP) with Denmark as Reference Member State (RMS) to submit bioequivalence study data in an additional format at the time of submission of the application or shortly thereafter.

Applicants must still submit data in eCTD format (electronic Common Technical Document format) as usual, but in addition they will also be asked to submit bioequivalence study data in CDISC format as a working document. The data in CDISC format should be submitted to both RMS and CMS.

The submitted CDISC data should comply with 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.

The Danish Medicines Agency will select a small number of applications to be included in the pilot study based on the following criteria:

• The legal basis of the application is Article 10.1 or 10.3 of Directive 2001/83/EC
• The application must contain data from at least one bioequivalence study
• As far as possible, the same applicant is included in the pilot study only once
• As far as possible, the same bioequivalence site is included only once in the pilot study

The applicants in the selected applications will be contacted directly by the Danish Medicines Agency as far as possible about one month before their allocated DCP submission slot or as soon as possible thereafter. However, the Danish Medicines Agency can also choose to include already submitted applications in the pilot study.