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

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 CTGTP379 KB, summarised below:

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):

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 CTGTP379 KB and their specified supporting documents

Fees and turnaround time

Refer to CTGTP fees and turnaround time for more information.

How to apply

Submit your applications through SHARE.