8 Online Applications for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for r-DNA products 2026-Mar-09 397 KB
Online Applications for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for r-DNA products - Reg.
ao
F. No. r-DNA-15011(11)/72/2025-eoffice (e-office no. 26991) Government of India Directorate General of Health Services Central Drugs Standard Control Organization (Biological Division)
FDA Bhawan, Kotla Road, New Delhi 110002 CIRCULAR Dated: 0 9 Bis 2025
Subject: Online Applications for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for r-DNA products - Reg.
In order to streamline the regulatory submission procedure, the submission of applications for Post Approval Changes (PAC) w.r.t Marketing Authorization for r-DNA products is functional now through Online System of SUGAM Portal (www.cdscoonline.gov.in) under "Post Approval Changes - MA"
online portalAll applicantsas per theseekingchecklistabovein thementionedmodule. PAC shall apply though
not The facility of offline submission of applications in hard copy will be available for processing from 05.03.2026.
==> picture [179 x 63] intentionally omitted <==
----- Start of picture text -----<br> ar Agi<br>Drtgs Centroller General (India)<br>----- End of picture text -----<br>
To,
-
All Stakeholders through CDSCO website
-
All Zonal/Sub Zonal Offices of CDSCO
-
CRU Section of CDSCO (HQ) 4. CDAC Team
Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.
No analysis has been generated for this document yet.