BREAKING NEWS | The Web-Based Variations eAF is now Live for all EU products!

February 11, 2025

We’re thrilled to announce that the web-based variations eAF is now ready for non-CAPs products across National Procedures (NP), Mutual Recognition Procedures (MRP), and Decentralized Procedures (DCP)!

  • Starting today, eAFs created on the PLM Portal can be submitted to National Competent Authorities.
  • This marks a significant step towards streamlining regulatory submissions.
  • Optional use for now—it’s not yet mandatory, but early adoption can bring efficiency benefits!

 

As experts in regulatory submissions and digital transformation, at Asphalion we can support you through this transition. Whether you need guidance or hands-on assistance, we’re ready to help!

Contact us at: [email protected]

For more details, visit the PLM Portal: https://plm.ema.europa.eu

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