Reply To: Labeling for Canada
October 31, 2022 at 7:13 pmIt is possible to label the vials with only 1 language and include FR/EN on the carton. Health Canada has published Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” that provides Agency interpretation of the labeling requirements specified in Annex 13. The guidance states “The definition of a label permits that the required information may accompany the drug (primary container, secondary container, package inserts, etc.).” and that “It would be up to the sponsor to determine how to comply with the labelling requirements set out in this provision, provided that the system in place is validated, traceable, and does not compromise patient safety or product quality. Proper rationale and justification should be used.”
There is justification for not including the date on the primary container. Although Annex 13 does not provide provisions for labeling small containers I have successfully supplied trials in Canada with reduced text in situations you describe. In addition to the above interpretations providing options for adjusting the text you would also be putting the material at risk by removing it from cryo storage and warming it just to change the expiry.
