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NOMA implements a new case processing platform for marketing authorization

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Changes

  • : Updated with new information as the case processing platform has now been adopted.
  • : Updated with launch date, an encouragement to make contact in case of errors, and a clarification that opportunities to make better use of European systems and processes are initially related to medicinal products for human use.
  • : The introduction has been corrected: The case handling platform will adopted in the third quarter.
  • : The text has been updated as the lauch of the new platform has been postponed to the third quarter of 2025.

On September 17th, NOMA replaced its system for processing new applications for marketing authorization, changes, and renewals with a new and more flexible platform.

This will streamline case processing and enable DMP to better utilize European systems and processes, initially related to human medicines. The new platform provides greater opportunities to optimize case handling. Metadata from submissions will be used for automatic case creation and workflow selection.

At the same time, this requires applicants to adhere to the guidelines for completing files accompanying a submission.

"Having correct data from the start ensures that the rest of the case processing follows the correct path", says project owner and strategic director Randi Tandle.
We ask companies to communicate this internally within their organizations and between them.

Challenging transition phase

DMP transitioned to the new platform on September 17th. Prior to this, all completed and ongoing cases were transferred from the previous system to the new platform. DMP asks the pharmaceutical industry to remain vigilant and report any issues that seem incorrect, such as misdirected emails.

"The transition to a new system is challenging. We must expect somewhat reduced capacity, which may also lead to some delays during a transitional period. At the same time, this is a significant and important investment for DMP that can bring benefits for both us and the industry", concludes Tandle.

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