Institute of Good Manufacturing Practices India®

EC: Modified Labelling Requirements for IMPs

With the publishing of Delegated Regulation 2022/2239, the European Commission has issued the revised and amended labelling prerequisites for unauthorized investigational and auxiliary medicinal products under the EU CTR (Clinical Trial Regulation). 

It eliminates the necessity to retroactively label the expiry date on the primary packaging of unapproved investigational products for which new stability and shelf-life data become available over time.

A new label was required earlier and applied to both outer and inner packaging. This arduous process, in turn, presented a risk to the safety and quality of the preparation. Given the risk's nature and magnitude, the Commission considers it appropriate and proportional that the period of use is omitted from the immediate packaging.

Annex VI to Regulation (EU) No 536/2014 is amended following the Annex to Regulation 2022/2239. The Regulation shall be mandatorily applicable in all European Member States as of 5 December 2022.