What is Annex VI

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

What is Annex VIAnnex VI EU No 536/2014 is a clinical trial regulation which will impose new labeling challenges to the industry within which regulatory requirements are already incredibly complex. These regulations will come into place six months after the Clinical Trials Portal and Database is completed. Therefore, the EMEA management have stated that Annex VI will be ratified in 2020.

Annex VI: The Key Points

Under the previous directive the inner packaging needed an expiry date and if changed, did not need to be updated on the inner pack and could be updated on an IRT system. Whereas, Annex VI requirements state that if subject to change, the expiry date must be physically replaced on both the inner and outer packaging which cannot be done by an IRT system.

How Annex VI can impact labeling:

  • The expiry date will take up space on your packaging.
  • In addition, the expire date can change 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 with longer and far less fluctuant expiry dates.
  • This means that the period of use must be in the inner packaging. This changes how often you have to open the pack to relabel which makes it expensive and time consuming.
  • It also requires a QP to be present to oversee the process. What happens if there is nobody available?
  • If the packaging is sent to a site with no DMP environment, then repackaging can be difficult or even impossible.

Just in Time Labeling: a solution?
JIT and On Demand are new production models that offer flexibility to clinical pack supply. The labels are being printed, packed and shipped within 48 hours so the most up to date expiry dates are being printed. Therefore, minimising the likelihood that your expiry dates are incorrect. Which in turn means it will be unlikely that you will need to update any expiry dates on your outer or inner packs.

A disadvantage is that you will need sophisticated labeling software that can deal with the practical requirements of JIT and utilise the latest correct data. In addition, the software must be flexible in order to handle regulatory fluctuation. A system such as this will take time to implement but will ultimately reinvigorate your production and supply operations.

How we can help with Annex VI

Gordon Alexander

About the author

Gordon Alexander, Enterprise Pre-sales Engineering, PRISYM ID

Gordon is involved in understanding customer needs and industry challenges to drive solutions to improve efficiency, minimize risk, address regulatory requirements and provide new approaches to business systems and processes. Gordon has 20 years of technical software experience with roles as industry consultant, business analyst, and pre-sales engineering.