MIV-2 Notification vs MIV-2 Do-and-Tell: What you need to know prior to submission

When making post-approval changes to chemical drugs registered in Singapore, understanding which MIV-2 changes require a Notification vs Do-and-Tell under HSA’s guidance is crucial for smooth regulatory compliance.

This distinction is explained in Annex 13B (MIV-2 Notification) and Annex 13C (MIV-2 Do and Tell) of the guidelines.

What is an MIV-2 Change?

MIV-2 refers to minor variations— lower-risk changes that require less stringent regulatory oversight.

Quick summary of MIV-2 type, implementation and examples

MIV-2 Notification (Annex 13B)	MIV-2 Do-and-Tell (Annex 13C)
Changes that requires prior notification to HSA and can be implemented after 40 working days if no objection is raised.	Changes that can be implemented immediately but must be notified to HSA within 6 months. They can be bundled.
Implementation can proceed after 40 working days from application submission if there are no queries from the authority.	No prior approval needed; just notify after implementation
Examples: minor change of manufacturing processing of drug product , change of batch size of non-sterile drug product, change of primary packaging material of non-sterile Drug substance or drug product	Examples: change of product owner , change of specification of drug substance to comply with latest compendium, revision of CEP

Tips to Note Prior to MIV-2 Submission

Assign the change to the correct MIV-2 category by carefully assessing the conditions listed under each type (Notification or Do-and-Tell).
Do-and-Tell changes may be submitted as standalone MIV-2 applications, or bundled with other related MIV-2 changes — provided they were implemented within the preceding 6 months.
Prepare documents according to the checklist for each category. For example, if a letter of justification has specific required content, please follow it exactly and do not modify the template.
Only one MIV-2 submission can be submitted at any one time for a single product. Please plan your changes in advance to avoid delays.
There is no application fee for MIV-2 submissions. The processing timeline is typically 40 working days, provided there are no queries from HSA.

Good luck, and reach out anytime if you need support with your MIV-2 submissions.

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