Overview of variation application types

Understand the differences between each type of variation application, and which is the correct one for you.

Types of variation applications

There are two types of variation applications of existing registered therapeutic products:

  • Major variation application (MAV)
  • Minor variation application (MIV)
Application type Conditions
MAV-1 
  • Any variation to the approved indication, dosing regimen or patient group(s).
  • Inclusion of clinical information extending the usage of the product, for example:
    • Clinical trial information related to an unapproved indication, dosing regimen or patient population.
    • Additional bacterial strains with clinical (in vivo) data to expand the indications for antimicrobial products.
    • Additional viral serotypes or genotypes to expand the indications for antiviral products, etc.
MAV-2  A change in the current approved forensic classification of the therapeutic product, also known as reclassification of therapeutic products.
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:

  1. 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  [
  2. 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.
  3. For MIV-2 (Notification)applications, 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").
  4. For MIV-2 (Do-and-tell) applications, applicants have 2 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.