NEW | EMA key updates on Product Management Service xEVMPD for MAHs

October 18, 2024

Last October 10th, the European Medicines Agency conducted the Webinar Product Management Service (xEVMPD) for Marketing Authorization Holders, in which important actions for MAHs were shared:

 

  • Submit herbal and homeopathic products, as well as pending MRPs and DCPs to xEVMPD.
  • Verify that non-CAPs have been properly migrated to PMS.
  • Submit pack sizes for products under the ULCM (Unlicensed Medicinal Product List) before January 31, 2025, using consistent package descriptions for multilingual countries.
  • Avoid referencing substances with SVG flag 0 and terms that need to be nullified in any new or existing product records in xEVMPD.
  • Review received 3rd Acknowledgements and communications from EMA and take the required product amendment actions.

 

From Asphalion we could provide additional information and support in the following areas:

  • xEVMPD Maintenance: Analyzing 3rd ACKs and submitting pack size structure data through xEVMPD.
  • Data enrichment in compliance with ISO IDMP
  • Reviewing your product in PMS
  • Correcting your data in PMS
  • Management of new tools on behalf of MAHs (PMS, RPM, eAF, ePI, etc.)

 

If you require any further information, contact us at: [email protected]

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