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July 30, 2021


What is Annex VI EU No 536/2014 and how does it affect labeling?

Gordon Alexander

Solution Architect

Annex VI EU No 536/2014 is a clinical trial regulation that will create new labeling challenges for an industry that already had incredibly complex regulatory requirements. It is currently planned for the regulation and accompanying Clinical Trial Information System (CTIS) to go live on 31 January 2022.

Why is it important and how does it affect your labeling software?

Annex VI is intended to help improve patient safety and the reliability and robustness of data generated in a clinical trial. It will directly impact some aspects of package labeling.

Previously, changes to the expiry date on inner packaging did not have to be physically made and could be updated on an IRT system. However, the new Annex VI requirements mean that any changes to the expiry date must be physically actioned on both the inner and outer packaging, which cannot be done by an IRT system.

The area for an expiry date may therefore require additional space on your packaging to account for potential changes during the clinical trial process. Expiry date changes are becoming increasingly frequent because of the increasing dominance of biologics over chemical-based products such as pills, which would have longer and more stable expiry dates.

This shift to biologics changes how often you may have to open the pack to relabel – an expensive and time-consuming activity that requires a QP to be present to oversee the process. What happens if there is nobody available? Plus, if the packaging is sent to a site with no DMP environment, then repackaging can be difficult or even impossible.

How can Loftware help?

The Just In Time (JIT) production model offers increased flexibility for the labeling and supply of clinical trial packs. Labels are printed, packed, and shipped within 48 hours so the most up-to-date expiry dates are being printed, minimizing the prospect that they would be incorrect. Ultimately, it will be unlikely that you will need to update any expiry dates on your outer or inner packs.

The Loftware PRISYM 360 cloud-based clinical trial labeling software can facilitate on-demand label printing, unlocking the JIT production model for clinical trial packs. It can also further smooth the label management process by enabling country-specific phrases, such as dosage instructions, to be defined and approved in advance, ensuring that only those language phrases appropriate for the destination country will be printed on the label.

  • Regulatory
  • Clinical Trials