I have this question for both US and EU region:

US region: We need to provide a standard of care drug which is a carton containing two pre-filled syringes. The material is US-sourced. How do I know what the requirements are to include on the label text for US? Can I only label the outer carton so the carton does not have to have the tamper seal broken and the pre-filled syringes will remain with the commercial label. If I end up labeling this as IP (include US caution statement) does that mean I have to label the primary packaging inside?

EU region: We need to provide a standard of care drug which is a carton containing two pre-filled syringes. The material is German-sourced but will be used for various member state countries (e.g. Poland, Spain, France, Germany). It is confirmed in the protocol and by our Medical team that it is considered standard of care across all our EU countries included in the study. Would I be able to label this material as AxMP or is it required to be labeled as investigational product? Since the primary label is in German would I have to add label text to the syringes no matter what? The space in the tray is extremely tight and I have concern of a flag booklet label fitting in the existing packaging.