Minor variation (MIV-1 or MIV-2) applications
Understand the requirements of MIV applications for changes to your registered Class 2 CTGTP.
Last updated 25 March 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], summarised below:
List of MIV applications
Change Type | Conditions |
MIV-1 |
|
MIV-2 (Notification) |
|
MIV-2 (Do-and-Tell) |
|
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. |
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] 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.