Singapore - Biologics Specifics Variation Requirements

Guideline on Minor Variation Applications for Biologics - April 2022

The variations are described in various Appendix 14 of the HSA Guideline.

Minor Variations (MIV 1) Guideline - Apr 2022

(Submission is required and approval is required)

appendix-14a_part-a_checklist-on-dossier-requirements-for-miv-1-variation.docx

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Minor Variations (MIV 2 - Notification) Guideline - Apr 2022

(Submission is required before implementation and implementation can proceed if no questions received from HA within 40 working days)

appendix-14b_part-b_checklist-on-dossier-requirements-for-miv-2-(notification)-variation.d

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Minor Variations (MIV 2 - Do-and-Tell) Guideline - Apr 2022

(Can be submitted within 6 Months after implementation)

appendix-14c_part-c_checklist-on-dossier-requirements-for-miv-2-(do-and-tell)-variation.do

Download DO • 56KB