News

New pharmaceutical legislation focusing on access to medicine and sustainability

Extension of price cap agreements on hospitals and pharmacy-restricted medicinal products

From 22 June 2023, the Medical Device Regulation (MDR) will also apply to certain types of devices without a medical purpose

New interesting decisions from ENLI

New judgment from the Court of Justice of the European Union on borderline products

The deadline for the certification of certain medical devices extended

Easier for companies to submit their products for evaluation by the Danish Health Technology Council

Increased competition from biosimilar medicines

All applications for authorisations to run a clinical trial must as of 31 January 2023 be submitted via the EU CTIS

New EU judgment on the classification of borderline products

ENLI expands the concept of professionalism