Investigational Medicinal Products: Labeling Changes And Their Implications

In May 2014, European Union Clinical Trial Regulation (EU CTR) No. 536/2014 was passed, replacing EU Directive No. 2001/20/EC to enhance clinical trial safety, efficiency, transparency, and collaboration. At the end of January 2022, the regulation went into effect, leaving life sciences companies three years to transition and meet the new requirements.

One of the most significant changes in the new regulation is Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries (no further local specificities other than translations). So, what are the implications of these changes, and how will they affect outer immediate packaging?