Derogation for sponsors of non-commercial clinical trials to adapt packaging/labelling of an investigational medicinal product that is on the market

date: 21/02/2022

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.  

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. 
A derogation application for low-intervention clinical trials according to the CTR Regulation is not necessary. 

From now on, the FAMHP consents to the absence of labels for treatments planned in trials that meet the "low or limited intervention" requirements:
•    the treatment is given according to the leaflet and the standard of care;
•    delivery takes place in accordance with the marketing authorisation (and thus without any changes to the medicinal product).

How to apply for a derogation for low-intervention clinical trials under Directive 2001/20/EC?
•    The derogation must be requested in the cover letter of the application for trial approval and is part of the approval. 
•    The sponsor is responsible for demonstrating at all times that the trial fulfils the conditions of a limited intervention trial.
•    For delivery via a public pharmacy, a reference in the dossier (cover letter and protocol) is sufficient to ensure traceability up to the patient.

What is meant by a "low-intervention clinical trial"?
A low-intervention clinical trial meets the following criteria:
•    the investigational medicinal products, excluding placebos, have a marketing authorisation;
•    according to the protocol of the clinical trial:
-    the investigational medicinal products are used in accordance with the terms of the marketing authorisation;
-    the use of the investigational medicinal products is evidence-based and supported by scientific publications on the safety and efficacy of those investigational medicinal products in any of the member states concerned;
•    the additional diagnostic or monitoring procedures do not pose more than a minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any member state concerned.
 

Last updated on 21/02/2022