Modification to Annex VI - labeling for clinical trials
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This initiative eliminates the obligation to include an expiry date on the immediate packaging of unauthorised medicinal products used in clinical trials in specific circumstances (e.g. on syringes).
The aim is to prevent additional safety and quality risks associated with the relabelling procedure and the need for more frequent re-supply, which may lead to delays in clinical trials.
Points 1 and 2 given in the Annex provides for these risk adaptations to unauthorised investigational and auxiliary medicinal products.
Feedback was given by 67 organisations & individuals including EFPIA, which supported the change.
The Annex to the Delegated Regulation therefore allows the omission of the expiration date from the immediate packaging:
- when it is too small or when it is intended to stay together with the outer packaging, and
- in cases where other means of labelling such as centralised electronic randomisation systems are used
However, the regulation does not remove the legal obligation to include this information on the outer packaging in these specific cases.
The legal basis for this Delegated Regulation is set out in Article 70 of the Clinical Trials Regulation (EU) 536/2014, which allows the Commission to adopt delegated acts to amend Annex VI to Regulation (EU) 536/2014 to ensure subject safety and the reliability and robustness of data generated in clinical trials.