The differences between MIV-1and MIV-2 applications are as follows:
Organising your MIV applications
If your variation involves a change under a MIV-1 category and a change under a MIV-2 category, you can submit one MIV-1 application for both of these changes.
- MIV-1 changes should be grouped together and submitted as one application if the changes are consequential. A consequential change is an unavoidable and direct result of another change e.g. a change of specifications is consequential to a change of manufacturing process.
- Grouping of non-consequential MIV-1 changes under one application is not allowed.
- You may submit up to a maximum of two concurrent MIV-1 applications per registered product.
- You may submit only one MIV-2 application at any one time.
- Multiple MIV-2 changes may be bundled in this application.
Application dossier requirements
You must submit the application dossier within 2 working days of the application and organise it in either an International Council for Harmonisation Common Technical Document (ICH CTD) or ASEAN CTD (ACTD) format used for the original NDA application. You need to submit all documents in English.
You will need to submit the following in your online application:
- Table of contents.
- Cover letter.
- Variation checklist(s).
- Table of summary of changes.
- Variation specific supporting documents
- Current approved and proposed product labelling (annotated and pristine copies), if applicable.
Each variation application must be accompanied by a checklist, completed by the applicant and attached in the online application form.
Choose the relevant checklist from Appendix 10 Guideline on Minor Variation Application for Class 2 Cell, Tissue or Gene Therapy Products333 KB for the respective dossier requirements. You may submit more than one checklist, where applicable.
All the supporting documents for each of the selected checklists for each application should be submitted, unless otherwise justified.
Indicate in the application form and cover letter if the proposed change affects multiple products and if there are other pending variation applications for the same CTGTP.
Note: You need to disclose all proposed changes in the variation checklist and in the Table of Summary of Changes details. Any undisclosed variation embedded in the submitted data, or any follow-on changes not requested, will not be considered for evaluation.
Fees and turn-around-time
Refer to CTGTP fees and turn-around-time for more information.
How to apply
Submit your application through the relevant application form. Ensure you have the following before submitting your application: