How we can help with Annex VI

How we can help with Annex VI

Updated EU Clinical Trial guidelines for Annex VI are coming into force... and will have a momentous impact on your current labeling practices.

EU Clinical Trial guidelines for Annex VI (previously Annex 13) will be enforced in the later part of 2019/2020. If your company hasn’t started implementing these changes, you need to act quickly. Previously, the expiry date was only required on external packaging, however under the new regulation, the expiry date must be clearly legible on both the primary and secondary packaging and use of an IRT (Interactive Response Technology) is no longer allowable.

One of the options to prepare for this regulation is Just in Time Labeling.

  • Accelerates speed-to-market.
  • Meets clinical trial regulation requirements.
  • Minimizes overall labeling costs, streamlines processes and reduces the resources.

CHOSEN BY THESE CUSTOMERS...