Minor variation (MIV) application
- Submit MIV applications
Submit MIV applications
Find out about the application requirements, fees and processing timelines specific for each type of MIV application.
Submission requirements
Application dossier requirements
You must submit the variation application dossier within two 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 |
| Cover letter |
PRISM |
| Checklist for MIVs |
PRISM |
| Table of summary of changes |
PRISM |
| MIV-specific supporting documents |
Administrative documents (Module 1/Part 1): PRISM
Other supporting documents: PRISMorCD |
| Current and proposed product labelling (annotated and pristine copies), where applicable |
PRISM |
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
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MIV for chemical therapeutic product
Choose the relevant checklist on dossier requirements. You may submit more than one checklist, where applicable:
MIV for biological therapeutic product
Choose the relevant checklist on dossier requirements. You may submit more than one checklist, where applicable:
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 Submission2051 KB 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.