Abridged evaluation route for MAV-1 application
Follow this guide for the documentary requirements, fees and turnaround time of an MAV-1 application of a therapeutic product via abridged evaluation route.
You may submit a major variation application (MAV) via the MAV-1 abridged evaluation route if the major variation has been evaluated and approved by at least one drug regulatory agency.
The proposed variation submitted to us should be the same as that approved by the regulatory agency that issued the proof of approval.
Application dossier requirements
You must submit the application dossier within 2 working days of the PRISM application and organise it in either an International Council for Harmonisation (ICH) Common Technical Document (CTD) or ASEAN CTD (ACTD) format. You need to submit all documents in English.
All administrative documents under Module 1 (ICH CTD) or Part I (ACTD) must be submitted in soft copy in PRISM.
The other parts of the ICH CTD or ACTD may be submitted online via PRISM or in a CD/DVD labelled with the following information:
Location in ICH CTD
Location in ACTD
Administrative documents and product information
Common technical document overview and summaries
Incorporated into Parts II, III and IV
Note: Refer to our guideline on the submission of a non-prescription pharmaceutical drug165 KB for eligibility on waiver of non-clinical and clinical documents.
Each application must be accompanied by a checklist, completed by the applicant and attached in PRISM.
Use one of the following application checklists for your choice of CTD. Each checklist provides details on the specific documents that need to be submitted with your application. Submit the completed checklist together with your application dossier for application screening.
Note: Your choice of CTD submitted for your original NDA will determine the submission format for the rest of your product's post-approval applications.
Fees and turnaround time
Refer to therapeutic product fees and turnaround time for more information.
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