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.

Eligibility

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. 

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, 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).

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 

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. 

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