Calyx RIM for XEVMPD

3rd Acknowledgement Type File

The 3rd Acknowledgement type file includes:
  • Message Header: contains information to identify the Acknowledgement message.
  • Acknowledgement: consists of multiple sections (described in the following table).
Note: The 3rd acknowledgement type is used to identify changes made by EMA during the QC process for authorised products only.

The number of received Acknowledgements depends on the number of sections in one submission message.

EMA performed no changes EMA performed changes
Section A

Section A is a message acknowledgment, summarizes the EMA findings on the 3rd Acknowledgment message type.

Possible results:

  • If all reports was successfully processed you will see transmissionacknowledgementsode = 1
  • Message number contains Product validated as submitted + <EV Code> + Version + <Validated Version Number> + / + <Date and Time>
  • Original message number contains <EV Code> + Version + <Version Number>
  • Original message date contains <Validated Date and Time>

Section A is a message acknowledgment, summarizes the EMA findings on the 3rd Acknowledgment message type.

Possible results:

  • If all reports was successfully processed you will see transmissionacknowledgementsode = 1
  • Message number contains Product validated following EMA edit of data + <EV Code> + Version + <Validated Version Number> + / + <Date and Time>
  • Original message number contains EMA edit of data + <EV Code> + Version + <Version Number used as based for the Changes>
  • Original message date contains <Validated Date and Time>
Section B

Section B is the acknowledgement report. This report summarizes the results of the validation made for each authorized medicinal product entry.

Possible results:

  • Operation type is 9
  • Operation result is 601
  • Operation result description: Product validated successfully as submitted

Section B is the acknowledgement report that summarizes the results of the EMA updates performed.

Possible results:

  • Operation type is 2
  • Operation result is 4
  • Operation result description Entity updated successfully Version + <Assigned Version Number> + <Provided product version changes>
File Name Validated + - + <Sender ID of the Validated Version> + - + <EV Code> + - + <Validated Version Number> + - + <Date and Time> + .xml ackval + _ + <EV Code> + _ + <New Version Number> + .xml

The number of received Acknowledgements depends on number of sections in one submission message. You receive one 3rd acknowledgement file per one submitted section.