Post-approval Change Submissions

Overview

Any change in the approved content should be submitted to Health Canada either as a supplement/amendment/annual report based on the complexity and impact on the quality of the product as per the HC guidelines.

Based on the impact of the change, the reporting categories of the post-approval changes are:

  • Level I-Supplements (Major changes)
  • Level II-Notifiable Changes (Moderate Quality Changes)
  • Level III-Annual Notification (Minor Quality Changes) and
  • Level IV- Record of changes

The criteria, supporting documents/data required and implementation timelines differ for each change and hence requires expertise for assessment of the change, development of strategies and submission of supplement/amendment/annual report.

Freyr Expertise

  • 01

    Preparation, submission and review of post-approval change submissions

  • 02

    DIN/ANDS/MF holder transfers

  • 03

    Review and submission of supplement/amendment for change in manufacturing site, batch size or formulation, route of synthesis, equipment, container closure system, specifications, test methods, shelf life.

  • 04

    Inclusion of additional source for starting material of drug substance

  • 05

    Assessment of reporting category and supporting documents

  • 06

    Evaluation of proposed change in accordance with the FDA’s guidelines

  • 07

    Tracking of due date for annual reports

  • 08

    Gap analysis, preparation and submission of supplement/amendment/annual report

  • 09

    Preparation of a relevant Regulatory strategy for post-approval change submission

  • 10

    Interaction and follow-up with the HC for review or approval of submitted changes

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