Overview of MAV-1 application

MAV-1 overview

A MAV-1 variation application applies to changes in a registered therapeutic product in any of the following areas:

• Approved indication.
• Route of administration
• Dosing regimen.
• Patient group.
• Inclusion of clinical information extending the usage of the product.

You can submit up to a maximum of three MAV-1 applications for each product registration at any one time.

There are three evaluation routes for a MAV-1 application, with different eligibility criteria and documentary requirements:

Evaluation route	Eligibility
Full	A major variation that has not been approved by any drug regulatory agency at the time of submission.
Abridged	A major variation that has been evaluated and approved by at least one drug regulatory agency.
Verification	A major variation that has been evaluated and approved by at least two of our reference drug regulatory agencies at the time of submission. The product has received full marketing approval by reference agencies following a complete independent scientific assessment. The MAV-1 must be submitted within three years from the date of approval by the chosen primary reference agency. The product does not need independent assessment by HSA to contextualise the benefit-risk profile due to local disease epidemiology, medical practice and/or public health considerations. Examples of products that may require such contextualised assessment are anti-infectives, vaccines etc. The product has not been rejected, withdrawn or approved via appeal process or pending deferral by a drug regulatory agency for safety or efficacy reasons.

MAV-1 fees and turnaround time

You may wish to consider which evaluation route to choose based on the fees and turnaround times, in the event that your product qualifies for more than one evaluation route.

Refer to therapeutic product fees and turnaround time for more information.

Evaluation stages

The evaluation stage begins after the application is accepted after screening. For applications submitted via the full or abridged evaluation routes, their evaluation will proceed through the four evaluation stages below. You may view the evaluation stage of your application at track@prism.

Evaluation stages	Description
Stage 1: Acceptance for evaluation	The application has entered the evaluation queue. This marks the start of the evaluation timeline
Stage 2: Active evaluation in progress	Applicants can expect to received the first set of evaluation queries (if any) from us towards the end of this stage.*
Stage 3: Evaluation at midway	Applicants are expected to submit the response to evaluation queries.
Stage 4: Completed evaluation	Evaluation is completed. Application is now undergoing the regulatory decision phase, after which a regulatory decision# will be issued. Applicants can still expect further queries from HSA during this stage.

*120-160 working days from acceptance date, depending on application type and evaluation route. For applications without any evaluation queries, recommended changes to product labels will be communicated to the applicant during the regulatory decision phase. Refer to Appendix 5_Target Processing Timeline126 KB  for more information.

#The issuance of a regulatory decision would mark the end of the evaluation timeline for a product application.

 

Progressive Payment Scheme

Applications under the GIRO payment scheme may opt-in for the Progressive Payment Scheme when they submit a MAV-1 via the full or abridged evaluation routes.

This option must be decided at the point of the application submission and cannot be changed once the application has been submitted. If you wish to change your selected payment scheme, you will have to withdraw and re-submit the application. All payments made, such as the screening fee, are non-refundable.

The Progressive Payment Scheme is not applicable for MAV-1 applications submitted via the verification route.

The table below shows the percentages of payments applicable for each stage of the evaluation under the progressive payment scheme.

Evaluation stages	Progressive payment scheme percentage
Stage 1: Acceptance for evaluation	30%
Stage 2: Active evaluation in progress	40%
Stage 3: Evaluation at midway	20%
Stage 4: Completed evaluation	10%

If an application under the progressive payment scheme is withdrawn during the evaluation stage, any fees that were charged, but not debited from the GIRO account, would remain payable. All payments made are non-refundable.

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, 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.
• PRISM submission date.
• Product name.
  
• Application type

• Contents of the CD/DVD (e.g. Module 2 and 5)

CTD checklists

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.

• ICH CTD checklist ( Appendix 2B Application checklist for MAV)
• ACTD checklist ( Appendix 3B Application checklist for MAV) 

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.

How to apply

Submit your application through PRISM. Ensure you have the following before you access the e-service:

• CRIS company account
• Corppass or HSA PIN

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