BREAKING NEWS | Important Update from Eudravigilance!

July 13, 2023

According to a recent communication from Eudravigilance, action is required from owners of development substance data in xEVMPD by the 1st of September, 2023.

If you are a Marketing Authorization Holder (MAH) of Investigational Medicinal Products (IMPs), you should retrieve your products’ information and identify the substance classification:

  • For unmapped substance data, request the creation of a new approved substance.
  • For mapped substance data, replace the development substance data.

 

Please note that if actions are not taken before THE 1st of September, 2023, the EMA will perform the product update on your behalf, referencing only approved substance(s).

Our team at Asphalion can assist you with the implementation of the requested actions. Don’t hesitate to reach out to us for support!!

For further information, you can contact us at: info@asphalion.com

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