Minor variation (MIV) application

  1. Overview

Overview

Understand how to submit a minor variation (MIV) application for your registered therapeutic product.

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Minor variation application types

Each minor variation (MIV) checklist for chemical and biological products are divided into MIV-1 and MIV-2 changes.

Check if your post-approval change requires notification to HSA in 
Appendix 13_Guideline on MIV Applications for Chemical Therapeutic Products183 KB
Appendix 14_Guideline on MIV Applications for Biological Therapeutic Products147 KB  

Application type Conditions
MIV-1

A minor variation that

  • Requires prior approval before the change(s) can be implemented.
MIV-2 (Notification)

A minor variation that
MIV-2 (Do-and-Tell)

A minor variation that 

Note: We may re-categorise the application, where appropriate. In such cases, we will notify you on the re-categorisation. Any screening fees paid are non-refundable or transferable for any application re-submission.

MIV-1 applications

There are two submission routes for MIV-1: the abridged route or the verification route.

An application may be submitted via the verification route if it fulfils both requirements below:

  1. The proposed variations are identical to those approved by one of our reference agencies.
  2. The application is accompanied by the proof of approval or approved product labels of that reference agency.

Applications that do not fulfil the requirements above have to be submitted via the abridged route.

MIV-2 applications

MIV-2 (Notification): You may implement the change if there are no objections from us within the notification timeline of 40 working days from the date of application submission. The notification timeline excludes the time taken by you to respond to our Input Request ("applicant's stop-clock").

MIV-2 (Do-and-tell):  You have two submission options.

  • 6-Monthly Notification: 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).
  • Flexible Notification: Submit a Do-and-Tell change anytime as a MIV-2 submission, or together with other standard MIV-2 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. You may also combine Do-and-Tell changes in an MIV-1 application provided that these are consequential changes.

Organising your MIV applications

If your minor variation involves a change under a MIV-1 category and a change under a MIV-2 category, you can submit one MIV-1 application for both of these changes

MIV-1

  • MIV-1 changes should be grouped together as one application and submitted as one MIV-1 application when the changes are consequential, such as a change of manufacturing process and change of specifications. A consequential change is an unavoidable and direct result of another change.
  • Grouping of non-consequential MIV-1 changes under one MIV-1 application is not allowed.
  • You may submit up to a maximum of five concurrent MIV-1 applications per registered product.

MIV-2 (Notification and Do-and-tell)

  • You may submit only one MIV-2 application at any one time. Multiple MIV-2 type changes may be bundled in this application.

Fees and turnaround time

Refer to therapeutic product fees and turnaround time for more information.

Next Submit MIV applications