86 Circular for PAC Online Applications for Clinical Trial of Vaccine 2023-Oct-26
In force — no superseding record on file.
File No. 7-5/2015/misc./034(e-Governance) Government of India Directorate General of Health Services Central Drugs Standard Control Organization (Biological- Vaccine Division)
FDA Bhawan, Kotla Road New Delhi 110 002 Dated:
CIRCULAR
==> picture [83 x 21] intentionally omitted <==
----- Start of picture text -----<br> (2 6 OCT 2023<br>----- End of picture text -----<br>
Subject: Online Applications for Post Approval Changes (PAC) w.r.t Clinical Trial Permission in Form CT-06 and Post Marketing Surveillance (PMS) Study for Human Vaccines and Anti-sera — Reg.
In order to streamline the regulatory submission procedure, the submission of applications for Post Approval Changes (PAC) w.r.t Clinical Trial Permission in Form CT-06 and Approval for Protocol / Report of Post Marketing Surveillance (PMS) Study for Human Vaccines & Anti-sera is functional now through Online System of SUGAM Portal (www.cdscoonline.gov.in) under “Post Approval Changes”.
All applicants seeking above mentioned PAC shall apply though online portal as per the checklist in the module.
The facility of offline submission of applications in hard copy will not be available for processing from 01.11.2023.
(Dr.Rajeev du) Drugs ControllerSinghGener.Ragh India)nshi) Centralicensing Authority
To,
- All Stakeholders through CDSCO website. 2. All Zonal / Sub-Zonal Offices of CDSCO. 3. 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 generated for this document yet (analysis runs over brief docs + on-demand). Run build_analysis.py --ids 24537 --apply.