biologics. 3. DEFINITION 3.1 Major variation (MaV) Variation to a registered pharmaceutical finished product that may affect significantly and/or directly the aspects of quality, safety and efficacy and it does not fall within t.

Find out about the application requirements, fees and processing timelines specific for each type of MIV application. You must submit the variation application dossier within two working days of the PRISM application.

This document provides guidance on minor variation applications for chemical drug products registered in Singapore. It outlines two categories of minor variations - MIV-1 which requires regulatory approval, and MIV-2 which requires notification.

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This document provides guidelines for variations to pharmaceutical products in ASEAN countries. It defines major variations (MaV) as changes requiring prior approval and minor variations as changes requiring either prior approval (MiV-PA) or notification only (MiV-N).

The remaining pack sizes are adequate to accommodate the dosing regimen as per the current approved product labelling. For addition of pack size for CTGTP, refer to MIV-1 A6.

This document describes the requirements of a Minor Variation Application (MIV) submitted for an existing registered chemical drug product in Singapore. Product registrants should be familiar with the contents of this document, Chapters F and H of this guidance and the governing legislation prior to submitting an MIV to HSA.

In Singapore, medical companies that plan to make a change to one of their pharmaceutical products, such as a change in labeling, packaging or manufacturing site, may submit a minor variation (MIV) application to the Center for Drug Administration under the Health Sciences Authority (HSA).

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