Hi,
1. If it is DS manufacturer name change without any change in process, address and product the impacted sections are 3.2.S.2.1 Manufacturer(s), in case of DP, the impacted section will be 3.2.P.3.1 Manufacturer(s), if any declaration is available it will be part of 3.2.r.
Regarding artwork- I believe its not required to include as it doesn't contain manufacturer name instead it contains distributor name.
2. According to section X. D.1 (PAGE # 26) of changes to NDA & ANDA guideline(attached) it is AR.
------------------------------
PELALA
------------------------------
Original Message:
Sent: 18-Jul-2017 04:17
From: Anonymous Member
Subject: US - CMC post-approval change submitted in Annual Report
This message was posted by a user wishing to remain anonymous
Hi,
I come from other country and not very familar with US regulation. May I seek your advice on below questions?
1. for change in manufacturer name only (no change in manufacturing process and product), what should be included in annual report? Is artwork required?
2. if IV bag label artwork is changed (e.g. change in layout), can I submit this change under aunnal report?
Thank you very much!