Acknowledgement File
Use the acknowledgement file to summarize medicinal product entry information required for future processing and authorization.
The Acknowledgement file consists of a message header and an acknowledgement report. The message header displays information that identifies the acknowledgement message.
The acknowledgement presents two sections:
- Message Acknowledgement: Summarizes findings on the message sent to the EMA for processing the medicinal product submitted for authorisation.
- Report Acknowledgement: Summarizes the results of the operation type (such as Insert, Update, Nulify, or Invalidate MA) requested for each medicinal product entry in an XEVPRM. It contains the mapping between the Local Code and the EV Codes.