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Date: 2024-01-03 Category: Not Applicable State: Union Government Country: India

Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT-18/CT-21) 2023

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This gazette notification provides details regarding rejected applications from Human Vaccine Manufacturers or Importers, specifically those applying using Form CT-18/CT-21 for the year 2023.

Key Changes

  • For the year 2023, there were no rejected applications from Human Vaccine Manufacturers or Importers using Form CT-18/CT-21. The gazette explicitly states 'Nil' for all fields, including the name of the firm, name of the vaccine, indication, and date of rejection.

Impact Analysis

Human Vaccine Manufacturers/Importers

  • Action Item: Continue to maintain high standards in application submissions and adhere to all regulatory guidelines to ensure continued success.

Government Regulatory Bodies

  • Action Item: Analyze application data to identify any trends or areas for improvement in the application process. Consider if additional resources or guidance could further streamline the process.

Public Health

  • Action Item: Monitor vaccine availability and address any potential supply chain vulnerabilities to ensure continued access to essential vaccines.

Key Entities Referenced

Human Vaccine Manufacturers/Importers: Entities involved in the manufacturing or importing of human vaccines. Form CT-18/CT-21: Application forms used by Human Vaccine Manufacturers or Importers. Year 2023: The specific year to which the rejection data pertains.
Official Source Record View Original Source →
See Full Document Text
Annexure - I(b) Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT- 18/CT-21) Year 2023 S.No. Name of Firm Name of Vaccine Indication Date of Rejection 1 Nil Nil Nil Nil Format No. QMS-GNL-019/F01(b)-00.

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