Verification evaluation route for MAV-1 application

Follow this guide for the documents required, fees and turnaround time of an MAV-1 application of a therapeutic product via verification evaluation route.

Eligibility

You may submit a major variation application (MAV) via the MAV-1 verification evaluation route if the variation:

  • Has been approved by at least two of our reference drug regulatory agencies at the time of submission.
  • Has been approved within three years by the chosen primary reference agency.
  • Does not need a more stringent assessment due to differences in local disease patterns or medical practices.
  • Has not been rejected, withdrawn or approved via appeal process or pending deferral by a drug regulatory agency for safety or efficacy reasons. 

Submission requirements

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:

  • PRISM application number.

  • PRISM submission date.

  • Product name.

  • 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 

Documents from primary reference agency

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.

In the event that the primary reference drug regulatory agency did not approve the most stringent indications, dosing regimens, patient groups and/or directions of use, the clinical assessment report from the reference drug regulatory agency that approved the most stringent indications, dosing regimens, patient groups and/or directions of use should be submitted.

Primary reference agency Documentary requirements
  • Health Canada
  • USFDA
  • UK MHRA
  • EMA
  • Complete clinical and quality assessment reports, including assessment on the question and answer documents between the sponsor and agency and all annexes.
  • Assessment, reports and documents pertaining to post-approval variations, if applicable.
TGA
  • Complete clinical assessment reports, including assessment on the question and answer documents between the sponsor and agency and all annexes.
  • Complete chemistry and quality control assessment report, including assessment on the question and answer documents between the sponsor and agency and all annexes.
  • Assessment, reports and documents pertaining to post-approval variations, if applicable.
  • Delegate’s overview.
  • Pre-ACPM response.
  • ACPM minutes.

Note:

  • If these documentary requirements for the verification route are not fulfilled, the application should be withdrawn. Any fees paid will not be refundable. A new application can then be submitted via the abridged route.
  • Consult us before submission if the therapeutic product has been:
    • Designated an Orphan Drug by at least one reference drug regulatory agency
    • Approved by at least one reference drug regulatory agency via an accelerated/fast-track approval or under exceptional circumstances.

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.

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

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