Denmark: Life Sciences, Biotechnology & Nanotechnology

The EU Council and European Parliament have agreed on a new “Pharma Package” – a major update to medicines rules in Europe. This is one of the biggest reforms in over 20 years. Once finally endorsed by the Council and the Parliament, the agreement will enter into force.

Registration of your company and medical devices in EUDAMED, the EU’s central database for medical devices, will become mandatory from the first half of 2026.

On 13 August, the UPC Court of Appeal held that a marketing authorisation alone is not enough, but once a health technology assessment (HTA), pricing and reimbursement are completed, imminent infringement may be established. Pharmaceutical companies must therefore monitor regulatory steps closely to act in time.

The ICH has adopted its revised Guideline for Good Clinical Practice (GCP) E6(R3) on 6 January 2025.

The European Commission has initiated a targeted evaluation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in order to assess the performance of the legislation.

The Danish Association of the Pharmaceutical Industry (Lægemiddelindustriforeningen, LIF) has recently published a guide on how to communicate green initiatives when marketing pharmaceuticals.

The regulatory interaction between medical device software, hardware and hardware components has been sought clarified in the new guidelines.

On 26 April 2023 the European Commission has put forth a proposal for a new Directive and new Regulation that will revise and replace the existing general pharmaceutical legislation.

ENLI has made several changes and clarifications in its guidance to the Promotion Code. Plesner provides a brief overview of the changes here.