84 Circular regarding online applicatioin for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for Human Vaccines and Anti-sera 2023-Nov-10 678 KB
Online Applications for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for Human Vaccines and Anti-sera — Reg.
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File No.X-11026/138/2022-BD 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:
Subject: Online Applications for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) 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 Marketing Authorization 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 01.12.2023.
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To,
- All Stakeholders through CDSCO website. 2. All Zonal / Sub-Zonal Offices of CDSCO. 3. CRU Section of CDSCO (HQ) 4. CDAC Team.
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