Where and by whom can package labeling of investigational medicinal products be done?
Investigational medicinal product (IMP) package labeling should comply with the Fimea regulation 8/2019 before release for use in a clinical trial.
Certain label details required by the regulation can in accordance with GMP Annex 13 be omitted, if justified according. In this case, it should be ensured that the information is available by other means, e.g. in a study card given to the participant or in an electronic system. These exceptions should not endanger the traceability of the IMP or the safety of the trial participants.
According to the Fimea regulation 8/2019 when IMP is dispensed, information about the participant or study visit may be added to the package label, but in a way that does not obscure the original label text. Entries added at the time of IMP dispensing may include e.g. details of the participant, visit number or additional instructions for use, and they can be done by the investigator or a delegated study team member (e.g. a study nurse) who has been appropriately trained.