2nd Acknowledgement Type File

The 2nd Acknowledgement type file includes:

Message Header: contains information to identify the Acknowledgement message.

Acknowledgement: consists of multiple sections:
  • Section A is a message acknowledgment, and summarizes the EMA findings on the message sent to EMA for processing medicinal product submitted for authorization.
  • Section B is the acknowledgement report. This report summarizes the results of the operation type (such as Insert, Update, or Nullify) requested for each medicinal product entry in an XEVPRM.

The name of the acknowledgement file should be presented in the following format: 'ack_'+<file name sent by the user>.