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Health Sciences Authority

Overview of variation application types

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

Last updated 5 May 2026

Types of variation applications

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

  • Major variation application (MAV)

  • Minor variation application (MIV)

Types of variation applications

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

  • Is specified under Part A_Checklist on Dossier Requirements for MIV-1 Variation of Appendix 13 (Chemicals) or Part A_Checklist on Dossier Requirements for MIV-1 Variation of Appendix 14 (Biologics).

  • Requires prior approval before the change(s) can be implemented.

MIV-2 (Notification)

A minor variation that 

  • Is specified under Part B_Checklist on Dossier Requirements for MIV-2 (Notification) Variation of Appendix 13 (Chemicals) or Part B_Checklist on Dossier Requirements for MIV-2 (Notification) Variation of Appendix 14 (Biologics); 

  • May be implemented within 40 days upon application submission if there are no objections raised by HSA

MIV-2 (Do-and-Tell)

A minor variation that 

  • Is specified under Part C_Checklist on Dossier Requirements for MIV-2 (Do-and-tell) Variation of Appendix 13 (Chemicals) or Part C_Checklist on Dossier Requirements for MIV-2 (Do-and-tell) Variation of Appendix 14 (Biologics); 

  • Does not require prior approval, but must be submitted to HSA within 6 months following implementation of the specified changes.

Note:

  1. Check if your post-approval change requires notification to HSA in 

    1. Appendix 13_Guideline on MIV Applications for Chemical Therapeutic Products

    2. Appendix 14_Guideline on MIV Applications for Biological Therapeutic Products  

  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. 

  5. For companies who are making changes to their business or company information such as company name, company address, contact details and other related information, please submit the change using the Change of Business Information e-Service.

    For change of applicant’s details for registrations and pending applications, please submit the change using the Amend applicant’s details for licences and applications e-Service.