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Industry specific-Medical Central Ministry of Health & Family Welfare National Medical Commission Act, 2019

Online Applications for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for Human Vaccines and Anti-sera

10-Nov-2023 | File No.X-11026/138/2022-BD

Central Drugs Standard Control Organization has issued a Circular regarding Online Applications for Post Approval Changes (PAC) concerning Marketing Authorization (MA) for Human Vaccines and Anti-sera. The key points from the Circular are: 1. Online Submission for PAC: The submission of applications for Post Approval Changes (PAC) related to Marketing Authorization for Human Vaccines and Anti-sera is now functional through the Online System of the SUGAM Portal (www.cdscoonline.gov.in). This process is under the "Post Approval Changes" section. 2. Mandatory Online Submission: All applicants seeking PAC for Human Vaccines and Anti-sera must apply through the online portal. The application should align with the checklist provided in the module. 3. Discontinuation of Offline Submissions: The facility of offline submission of applications in hard copy will not be available for processing from December 1, 2023.

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