Under what conditions can the exipiry date on an investigational product package label be updated at the clinical trial site (change of package label)?
The expiry date (use-by date, period of use) can be changed by a written commission of the sponsor. According to the Fimea regulation 8/2019 the expiry date information can be changed at the clinical trial site on label of the IMP available at the site, when justified from the point of view of the quality of the IMP and continuation of the trial. The change of expiry date on the package label does not have to be notified to Fimea.
Principles of GMP as stated in GMP Annex 13 have to be followed also when the expiry date labeling change is done at the clinical trial site. In other words, the labeling change has to be appropriately instructed and documented, and the person doing the labeling update (e.g. monitor or study coordinator) has to be appropriately trained in principles of GMP relevant for labeling. It must be ensured, that in the facilities where the operation is made, there is no risk for mix up of the IMPs and that possible storage conditions are appropriately taken into consideration.