Derogation for sponsors of non-commercial clinical trials to adapt packaging/labelling of an investigational medicinal product that is on the market
February 21, 2022
The European Regulation 536/2014 (Clinical Trial Regulation, CTR) came into force on 31 January 2022 and allows the packaging/labelling of investigational medicinal products already on the market not to be adapted for the clinical trial, except under special circumstances.
Source: FAMHP
The current legal framework imposes the labelling of investigational medicinal products. However, the European Regulation 536/2014, which came into force on 31 January 2022, allows an exception for medicinal products already on the market (except where the specific circumstances of a clinical trial, provided for in the protocol, require so in order to ensure the safety of the subject or the reliability and robustness of data generated in a clinical trial). Investigational medicinal products tested in low-intervention clinical trials are an example of that.
In that case, the same derogation could be granted under Directive 2001/20/EC for low-intervention clinical trials with a non-commercial sponsor. A derogation application has to be submitted to the FAMHP specifically for these clinical trials.