The Medical Products Division of the Bhutan Food and Drug Authority (BFDA) is pleased to present the draft Guideline for Post-Approval Variation of Market Authorization of Medicinal Products for your review and feedback.
This guidance document is designed to provide technical assistance to pharmaceutical product suppliers regarding the application procedures for Post-Approval Variation (PAV) submissions. It outlines the types of variations permitted for medicines that have already been approved and provides detailed guidance on the compilation of necessary documentation for such applications.
We kindly request that you submit your comments, suggestions, or recommendations to help enhance the guideline. Please send your feedback to schophel@bfda.gov.bt by April 30, 2025.
Thank you for your valuable input and cooperation.