The European Commission has announced a change to the labelling requirements of unauthorised IMPs used in Clinical Trials under the EU CTR (Clinical Trials Regulation).

CTR Annex VI requires all IMP labels to have period of use (expiration date) on both immediate and outer packaging. This commission delegated regulation states that it is no longer required to have the period of use (expiration date) on the primary packaging where not feasible and in situations where this may result in potential quality and safety risks to the product [1]. For example, blister packs, products with tamper evident seals etc.

This change will enter into force from the 5th of December 2022.

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Sources

[1] Publications Office (europa.eu)