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Health Sciences Authority

2. Submit MIV applications

Find out about the application requirements, fees and processing timelines specific for each type of MIV application.

Last updated 7 June 2026

Submission requirements

Application dossier requirements

You must submit the variation application dossier within five working days of the PRISM application. The dossier has to be submitted in the same Common Technical Document (CTD) format used for the original application. You need to submit all documents in English.


The MIV application submission requirements are as follows:

Documents required

How to submit

PRISM application form

PRISM

Table of contents

PRISM/eCTD

Cover letter

PRISM/eCTD

Checklist for MIVs

PRISM/eCTD

Table of summary of changes

PRISM/eCTD

MIV-specific supporting documents

Administrative documents (Module 1/Part 1): PRISM
Other supporting documents: PRISM, CD /DVD or cloud-based file exchange software (EasiSHARE)

Current and proposed product labelling (annotated and pristine copies), where applicable

PRISM/eCTD

Checklists for MIVs

Each MIV application must be accompanied by a checklist, completed by the applicant and attached in PRISM.

Unsure of which checklists to submit?

Use our tool to determine the suitable checklists for your post-approval variations

Go to tool

MIV for chemical therapeutic product

Choose the relevant checklist on dossier requirements. You may submit more than one checklist, where applicable:

  • Part A: Checklist on Dossier Requirements for MIV-1 Variation for Chemical Therapeutic Products

  • Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation for Chemical Therapeutic Products

  • Part C: Checklist on Dossier Requirements for MIV-2 (Do-and-Tell) Variation for Chemical Therapeutic Products

MIV for biological therapeutic product

Choose the relevant checklist on dossier requirements. You may submit more than one checklist, where applicable:

  • Part A: Checklist on Dossier Requirements for MIV-1 Variation for Biological Therapeutic Products

  • Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation for Biological Therapeutic Products

  • Part C: Checklist on Dossier Requirements for MIV-2 (Do-and-Tell) Variation for Biological Therapeutic Products

All the supporting documents for each of the selected checklists for each MIV application should be submitted, unless otherwise justified.

Indicate in the PRISM application form and cover letter if the proposed change affects multiple products and if there are other pending variation applications for the same pharmaceutical drug.

Note: You need to disclose all proposed changes in the MIV checklist and in the Table of Amendment details. Any undisclosed variation embedded in the submitted data, or any follow-on changes not requested, will not be considered for evaluation.

How to apply

Submit your application through PRISM. Ensure you have the following before you access the e-service:

If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).

Refer to our Guideline on PRISM Submission for more details on how to submit.

More details on submission requirements may be found in our Guidance on Therapeutic Products Registration

To make an expedited review request which meets one of the following criteria, click here:

i. There is no equivalent or alternative therapeutic option to the product in the Singapore market.

ii. The product is urgently required for supply under the National Procurement by ALPS.

iii. The requested change is mandatory and forms a crucial part of the National Procurement by ALPS.