This message was posted by a user wishing to remain anonymous
Hello,
Do you mean by regulatory sponsor information, the assigned Saudi Authorized Representative (AR) information?
- if yes, it is not required to be add on the labeling, as per SFDA MDS-REQ1 document (labeling requirements are listed in the EPs). REQ1Ar_0.pdf (sfda.gov.sa)
Best Regards,
__PRESENT
__PRESENT__PRESENT
Original Message:
Sent: 23-Jul-2023 10:35
From: Anonymous Member
Subject: Saudi Arabia labeling requirements
This message was posted by a user wishing to remain anonymous
Hello
Page 7 of the importers' guide says something about attaching the marketing authorization. Perhaps this is done in Saudi Arabia and not by the manufacturer.
https://www.sfda.gov.sa/sites/default/files/2021-09/t-140.pdf
Original Message:
Sent: 18-Jul-2023 13:58
From: Anonymous Member
Subject: Saudi Arabia labeling requirements
This message was posted by a user wishing to remain anonymous
Hello,
Does anyone know if regulatory sponsor information is required on labeling (IFU, product package labels etc.) for Saudi Arabia? I can't find anything in the regulations to suggest that it is but given that this type of information is required for other markets, I find it difficult to believe that it wouldn't also be required for Saudi.
Thanks in advance!