The EMA has updated its Question and Answers (Q&A) on Good Clinical Practice (GCP) by revising the followings :
>Investigational medicinal products (IMPs) in bioavailability and bioequivalence trials
3. How should the containers be labelled? Rev. March 2022
Labelling shall be such as to ensure protection of the subject and traceability, to enable identification of the product and trial, and to facilitate proper use of IMP.
Labelling of the containers should conform with the local regulatory requirements. The labelling on each container should comprise the necessary information as…