Guidelines for new applicants for marketing authorisations for medicines

Updated 16 January 2017

If you are a first-time applicant, we recommend you to consult the applicable rules and guidelines before drawing up the required application documents and completing the relevant application forms.

You can find information on the websites of the Danish Medicines Agency, the European Medicines Agency, the European Commission and the Heads of Medicines Agencies. The relevant links are listed in the box to the right.

Most of the relevant legal texts regarding marketing authorisation applications for medicines can be purchased at Schultz Boghandel, Herstedvang 10, DK-2620 Albertslund, Denmark.

The list below contains relevant documents which we recommend you to consult, irrespective of the procedure chosen, before applying for a marketing authorisation for a medicinal product. However, please be aware that most of the legal texts are only available in Danish.

  • Executive order on the Danish Medicines Act no. 506 of 20 April 2013.
  • Executive order on marketing authorisation for medicinal products etc., no. 828 of 1 August 2012 (in Danish only, Danish title: 'Bekendtgørelse om markedsføringstilladelse til lægemidler m.m.').
  • Executive order on the labelling etc. of medicinal products, no. 869 of 21 July 2011  as amended (in Danish only, Danish title: 'Bekendtgørelse om mærkning m.m. af lægemidler').
  • Executive order on the manufacture and import of medicinal products and intermediate products, no. 1358 of 18 december 2012 (in Danish only, Danish title: 'Bekendtgørelse om fremstilling og indførsel af lægemidler og mellemprodukter').
  • Application form for the granting of authorisations for handling of medicinal products (in Danish only, Danish title: 'Skema til ansøgning om virksomhedstilladelse til håndtering af lægemidler'. Please find a link to the form in the right-hand box).
  • Danish Drug Standards (in Danish only).
  • Executive Order on Fees Payable for Medicinal Products etc., no. 1571 of 16 December 2013
  • Executive order on the quality of medicinal products, no. 1211 of 7 December 2005 (in Danish only, Danish title: 'Bekendtgørelse om lægemidlers kvalitet, nr. 1211 af 7. december 2005').
  • Executive order on product numbers for medicinal products
  • The Rules Governing Medicinal Products in the European Union (EudraLex).
    • Vol. 1: Pharmaceutical Legislation: Medicinal Products for Human Use
    • Vol. 2: Notice to Applicants - Human
      • A: Procedures for Marketing Authorisation
      • B: Presentation and Content of the Dossier 1998 and 2001 versions
      • C: Regulatory Guidelines
      • Vol. 3: Medicinal Products for Human Use: Guidelines
        • - Quality Guidelines
        • - Biotechnology Guidelines
        • - Non-Clinical Guidelines
        • - Clinical Efficacy and Safety Guidelines
        • - Multidisciplinary Guidelines
        • Vol. 4: Good Manufacturing Practice, Hum. and Vet.
        • Vol. 5: Pharmaceutical Legislation: Veterinary Medicinal Products
        • Vol. 6: Notice to Applicants - Veterinary
          • A: Procedures for Marketing Authorisation
          • B: Presentation and Content of the Dossier
          • C: Regulatory Guidelines
          • Vol. 7: Veterinary Medicinal Products: Guidelines
            • A: General, Efficacy, Environmental Risk Assessment
            • B: Immunologicals, Quality
            • Vol. 8: Maximum Residue Limits
            • Vol. 9: Pharmacovigilance, Hum. and Vet.
            • Vol. 10: Clinical Trials

            The Danish Medicines Act, executive orders and guidelines are available in the box to the right.