Has anyone implemented a JIT model where the vial (primary packaging) does not include the protocol number, and the protocol number is applied only at the secondary (carton) level via JIT labeling?

In our case:

The vial label would contain core product information (e.g., product name, strength, route, “For Clinical Trial Use Only”) and the Med ID, but no protocol number.

The carton would also include the Med ID and would be labeled using a multilingual JIT approach, where the protocol number and potentially the expiry date are applied at a later stage.

The vial would remain inside the carton until use, and the product is administered in a controlled clinical setting.

I would appreciate insights on:

How was the absence of the protocol number on the primary packaging justified in HA / CTA / CTIS submissions?

Was the protocol number included only on secondary (JIT) labeling within the dossier mock-ups?

Did any Health Authorities require the protocol number to appear on the primary label despite this model?

Thank you in advance for sharing your experience.