Home› India› Ministry of Health and Family Welfare› Details of rejected applications of Human Vaccine Manufactur...
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) 2021

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

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

Overview

  • This gazette notification pertains to the rejection of applications from Human Vaccine Manufacturers or Importers in the year 2021.
  • The information is presented as an annexure detailing the rejected applications using Form CT-18/CT-21.

Key Changes

  • There were no rejected applications from Human Vaccine Manufacturers or Importers in the year 2021.
  • The table provided in the gazette lists 'Nil' for all fields, indicating no rejections.
  • The gazette references Form CT-18/CT-21, which is used for applications by Human Vaccine Manufacturers or Importers.

Impact Analysis

Human Vaccine Manufacturers/Importers

  • Action Item: Continue to adhere to regulatory guidelines and submission requirements to maintain a high approval rate.

Government (Regulatory Bodies)

  • Action Item: Review application processes and approval criteria to ensure continued efficiency and maintain standards. Analyze submission data to identify any trends or areas for improvement.

Patients/Public

  • Action Item: Monitor vaccine availability and public health needs to ensure adequate supply and distribution.

Key Entities Referenced

Human Vaccine Manufacturers/Importers: Entities involved in the manufacturing or importing of vaccines for human use. These entities are subject to regulatory oversight and must adhere to specific guidelines for application and approval. Form CT-18/CT-21: Application forms used by Human Vaccine Manufacturers or Importers. These forms likely contain detailed information about the vaccine, manufacturing process, and other relevant data required for regulatory approval.
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 2021 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.

Continue your research

Related Documents from Ministry of Health and Family Welfare