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Date: 2023-03-15 Category: Not Applicable State: Union Government Country: India

Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT-18/CT-21) 2022

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

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Executive Summary & Key Takeaways

What it means

  • The gazette notification provides details of rejected applications from Human Vaccine Manufacturers or Importers for the year 2022, specifically those submitted using Form CT-18/CT-21.

Key Changes

  • For the year 2022, there were no rejected applications from Human Vaccine Manufacturers or Importers (Form CT-18/CT-21).
  • The provided information is based on Format No. QMS-GNL-019/F01(b)-00.

Impact Analysis

Human Vaccine Manufacturers/Importers

  • Action Item: Continue to adhere to the guidelines and requirements specified in Form CT-18/CT-21 to maintain a high approval rate.

Government (Regulatory Bodies)

  • Action Item: Analyze the application approval process to identify potential areas for improvement and ensure continued efficiency.

Patients/Public Health

  • Action Item: Monitor vaccine availability and address any potential supply chain issues to ensure public health needs are met.

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. QMS-GNL-019/F01(b)-00: Format number for the document detailing rejected applications.
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 2022 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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