Follow this guide for the documents required, fees and turnaround time of an MAV-1 application of a therapeutic product via verification evaluation route.
You may submit a major variation application (MAV) via the MAV-1 verification evaluation route if the variation:
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, CD/DVD or cloud-based file exchange software (EasiShare). To request for access to EasiShare for dossier submissions, please click here.
CD/DVD submissions should be labelled with the following information:
PRISM application number.
Application type.
Contents of the CD/DVD (e.g. Module 2 and 5).
Documents
Location in ICH CTD
Location in ACTD
Administrative documents and product information
Module 1
Part I
Common technical document overview and summaries
Module 2
Incorporated into Parts II, III and IV
Quality documents
Module 3
Part II
Non-clinical documents
Module 4
Part III
Clinical documents
Module 5
Part IV
For an application submitted under this route, you need to declare one of the reference drug regulatory agencies as the primary reference agency from which the qualifying supporting documents will be submitted. This includes the compulsory submission of the unredacted and unedited assessment reports and supporting documents from the chosen primary reference agency.
Note:
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.
Refer to therapeutic product fees and turnaround time for more information.
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
Regulatory overview
Register your product
Apply for post-approval variation
Reclassify your product
Dealer's licensing and certification
Retain, cancel or transfer product registration
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Report adverse events
Report or recall defective products
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International collaboration
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Listing of approvals and post-registration actions
Guidance documents
Fees and turnaround time
PRISM (Therapeutic products)
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