Artwork Regulatory Challenges

While getting approvals in the EU and UK is the endpoint, in order to be compliant, MAHs must also look into the  artwork and packaging requirements that may rise due to the change in the country of origin. The packaging containers affected by artwork changes includes but is not limited to:

  • Cartons
  • Foils
  • Containers
  • Tubes
  • Inserts
  • Packets
  • Shippers

All the packaging containers listed above might have representatives’ details as per existing MAHs. But with the need to obtain new approvals, the registered addresses of the legal entities and other mandatory details might also be changed. Aligning with all the requirements and obtaining a market approval in the midst of stringent timelines will be a challenging task.

With Brexit transition deadlines inching closer, pharmaceutical manufacturers must ensure that they are adequately prepared to continue marketing without any compliance issues.

To expedite the process of submission for marketing authorization approvals (MAAs), consulting a Regulatory expert for artwork and submission is advised. 


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