Labelling IMP and AxMP

Investigational and auxiliary medicinal products should be appropriately labelled in order to ensure subject safety and the reliability and robustness of data generated in clinical trials, and in order to allow for the distribution of those products to clinical trial sites throughout the EU.

Labelling requirements for IMPs and AxMP are set out in chapter X and Annex VI of the CTR. Overview of labelling requirements is in development.

There is no need to submit a mock up of the label. Only the text that is labelled on the IMP, as per Chapter X and Annex VI of the Clinical Trials Regulation, should be included in the application dossier. The language of the information on the label should be in Dutch for studies performed in the Netherlands. Multiple languages are allowed. A list of information which is to appear on the outer packaging and immediate packaging is set out in Annex VI.