Find out about the application requirements, fees and processing timelines specific for each type of MIV application.
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:
Each MIV application must be accompanied by a checklist, completed by the applicant and attached in PRISM.
Use our tool to determine the suitable checklists for your post-approval variations
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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.
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.
Regulatory overview
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