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.

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

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