Reply To: Date format for IMP In EU
February 2, 2023 at 9:07 amA justification can be written to indicate that this would not require an update to the Regulatory filing. As the date is not ambiguous then a file note to cover the justification as to the fact that the date is not in the format could be made and this could be part of the annual update. The issue may be that the QP is stating that the label is not as per the label registered with the Competent Authorities this could be covered by a Risk assessment at the certification site. There may be other factors that the QP has concerns about regarding the issue so my recommendation is to speak to the QP so that you fully understand any concerns that they may have.
