Top FAQs on EVMPD

We have collected the most frequently asked questions that our team has been asked on topics regarding EVMPD and wrote down the answers in this article.

On the content of a xEVPRM message:

  • Submission Type
    There is no use of the submission type “variation”. If changes to an already uploaded MA are required, the submission type “update” has to be used. (Exception for renewals that receive a new MA-number on renewal)
  • Substances
    EMA no longer accepts updates on substances via xEVPRM messages. For the introduction of new translations or updates on the substances the EMA’s EVMPD support desk has to be contacted. This also means that xEVPRM messages only contain the EVcodes of substances but no longer the substance section itself.
  • Attachments
    Please refer to the “on attachment” section below.

On attachments:

  • Attachments will never be sent with the submission type “update”. Any attachment having a newer version number than its forerunner will be sent as “insert”.
  • Printed Product Information (PPI)
    If the PPI of a MA contains less required information than the xEVPRM message on the MA, then the EMA requires that this information is added to the end of the PPI.

On the use of operation types:

  • Use of Invalidate Marketing Authorization (MA) is allowed
    • After having withdrawn a MA.
    • After selling your MA.
    • After receiving a new MA-number, after a renewal (you will have to send an insert message on that MA with the new MA-number and the previous EVCode afterwards).
  • Use of nullify
    • Only when a product should never have been sent to the EMA is the usage of nullify allowed (e.g. to remove duplicated entries).
  • Use of update
    • Will never be used for attachments.
    • Any other form of an update not mentioned before will use that operation type.
  • Use of insert
    • Used for any new MA.
    • Used in special cases for a MA that has received a new MA-number, after a renewal.
    • Used for any new version of an attachment.

On visibility of data:

  • All information being sent to the EMA in a xEVPRM message will be visible to all users of the EVWeb.

On duplicated records:

  • In order to resolve a duplication in the controlled vocabulary, e.g. Marketing Authorization Holder (MAH), please contact the EMA EVMPD support desk. It may be necessary to contact the EMA-Support via mail to remove duplicates or change the record of ownership.

 

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