Denmark: Food and Drugs Law

The EU Court of Justice faces a pivotal decision on whether medicines approved as monotherapy but labeled for use in combination with other drugs qualify for Supplementary Protection Certificate (SPC) protection as combinations of active ingredients. This referral, stemming from Genmab's attempts to secure SPC protection for loose combinations including daratumumab, could resolve over a decade of legal uncertainty and fundamentally reshape how pharmaceutical companies approach regulatory strategy for combin

A new application process and accompanying guidance will hopefully make it easier to get started with such studies.