Minor variation (MIV-1 or MIV-2) applications

Understand the requirements of MIV applications for changes to your registered Class 2 CTGTP.

Last updated 4 June 2026

About MIV-1 and MIV-2

You must submit relevant MIV applications for your registered Class 2 CTGTP as specified in Part A through C of the MIV Checklist for Class 2 CTGTP [PDF, 419 KB] (opens in new tab), summarised below:

List of MIV applications

Change Type	Conditions
MIV-1	See Part A of the MIV Checklist Requires HSA’s approval before the change(s) can be implemented.
MIV-2 (Notification)	See Part B of the MIV Checklist Requires HSA’s approval before the change(s) can be implemented.
MIV-2 (Do-and-Tell)	See Part C of the MIV Checklist No prior approval required from HSA i.e. changes can be implemented directly. Application must be submitted within 6 months of the change implementation (see options below).

Inform us of your Do-and-Tell changes via one of two MIV-2 submission options below:

1. 6-Monthly Submission: Consolidate all Do-and-Tell changes that have been implemented within a 6- month timeframe of the scheduled submission periods of:

January (changes made from July to December of the preceding year) AND
July (January to June of the present year).

2. Flexible Submission: Submit a Do-and-Tell change anytime as an MIV-2 submission, or together with other MIV-2 (Notification) changes, provided that the change was implemented within the preceding 6 months.

If the same Do-and-Tell change was amended and re-implemented during the 6- month timeframe, only the latest version of the change should be submitted.

Organising your applications

At any one time, you may submit up to four concurrent MIV-1 applications and only one MIV-2 application for each registered CTGTP.

If there are multiple changes, follow the guide below to organise your submission(s):

List of submission options

Change category	Submission options
MIV-1 only	MIV-1 changes should be grouped and submitted as one MIV-1 application if the changes are consequential. A consequential change is an unavoidable and direct result of another change e.g. a change of specifications is consequential to a change of manufacturing process. Grouping of non-consequential MIV-1 changes under one application is not allowed. You will be requested to withdraw and resubmit separate applications.
MIV-2 only	Multiple MIV-2 changes can be bundled in one MIV-2 application. For Do-and-Tell changes, the MIV-2 application must be made within 6 months of the date of implementation.
MIV-1 and MIV-2	If your variation involves an MIV-1 change and an MIV-2 change, you can bundle both changes and submit as one MIV-1 application.

Change category

Submission options

MIV-1 only

MIV-1 changes should be grouped and submitted as one MIV-1 application if the changes are consequential. A consequential change is an unavoidable and direct result of another change e.g. a change of specifications is consequential to a change of manufacturing process.

Grouping of non-consequential MIV-1 changes under one application is not allowed. You will be requested to withdraw and resubmit separate applications.

MIV-2 only

Multiple MIV-2 changes can be bundled in one MIV-2 application. For Do-and-Tell changes, the MIV-2 application must be made within 6 months of the date of implementation.

MIV-1 and MIV-2

If your variation involves an MIV-1 change and an MIV-2 change, you can bundle both changes and submit as one MIV-1 application.

Submission requirements

You will need to submit the following in your online application:

Table of contents
Cover letter
Table of summary of changes which must include all of the following:
- Section(s) of the original dossier affected by the change(s)
- Approved and proposed condition(s)
- Reason(s) for the change(s)
- Registration status and date of approval of the proposed change(s) in other countries/agencies
Relevant MIV Checklist for Class 2 CTGTP [PDF, 419 KB] (opens in new tab) and their specified supporting documents

You need to disclose all proposed changes in the Table of summary of changes. Any undisclosed variation embedded in the submitted data, or any follow-on changes not requested, will not be considered for evaluation.

Your application dossier must be organised in the same ICH CTD/ACTD format submitted in the original NDA for your CTGTP registration.

All documents must be in English. For documents which are not in English, a certified translation is acceptable.

HSA may notify the applicant to withdraw and resubmit the application under a more appropriate variation type, where necessary.

Fees and turnaround time

Refer to CTGTP fees and turnaround time for more information.

How to apply

Submit your applications through SHARE (opens in new tab).