Fees and turnaround time for active ingredients

Here is the list of fees and turnaround times to help you with your active ingredients transactions.

Importer’s and wholesaler’s licence application

Application for a new licence

Licence Type Fee 
Importer's Licence (full scope)  $2,680  

Importer's Licence (limited scope) for the following restricted activities:

  • Importing active ingredients solely for export only.
  • Importing active ingredients for manufacturing relevant health product(s) for non-clinical purposes
  • Importing active ingredients for purposes other than for the manufacture of relevant health products(e.g., for research, reference standards, etc.)
  $400
 Wholesaler's Licence  $2,680
Note:
  • Licences are valid for 12 months from the date of licence approval. Renewal of licences must be submitted and processed before the expiry.
  • Turnaround time is 10 working days from the date of audit close out.
  • Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Renewal fees

Licence Type Fee   
Importer's Licence (full scope) $930  

Importer's Licence (limited scope) for the following restricted activities:

  • Importing active ingredients solely for export only.
  • Importing active ingredients for manufacturing relevant health product(s) for non-clinical purposes
  • Importing active ingredients for purposes other than for the manufacture of relevant health products.(e.g., for research, reference standards, etc.)
 $220
Wholesaler's Licence $930

Amendment fees

Amendment Fee 
Amend an importer's licence or wholesaler's licence with technical assessment $2,250  
Amend an importer's licence or wholesaler's licence without technical assessment $400 
Note:
  • Turnaround time is 10 working days from the date of technical assessment completion / audit close out.
  • Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Payment modes

Manufacturer’s licence application

Application for a new licence

Manufacturer's Licence Fee 
Manufacture of any active ingredient  $31,790 
 Primary (with or without secondary) packaging  $18,290 
 Secondary packaging only $9,290 
Note:
  • Licences are valid for 12 months from the date of licence approval. Renewal of licences must be submitted and processed before the expiry.
  • Turnaround time is 10 working days from the date of audit close out.
  • Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Renewal fees

Manufacturer's Licence Fee
Manufacture of any active ingredient $12,720
Primary (with or without secondary) packaging $6,100
Secondary packaging only $3,470

Amendment fees

Manufacturer's Licence Fee
Manufacture of any active ingredient $15,230 (With technical assessment)

$450 (Without technical assessment) 
Primary or secondary packaging only $8,720 (With technical assessment)

$450 (Without technical assessment)
Note:
  • Turnaround time is 10 working days from the date of audit close out.
  • Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Payment modes

Good Manufacturing Practice and Good Distribution Practice certificates

Fees

Application type Fee 
 Good Manufacturing Practice (GMP) certificate (with technical assessment)   $31,790  
 Good Manufacturing Practice (GMP) certificate (without technical assessment)   $220
 Good Distribution Practice (GDP) certificate (with technical assessment) $5,410 
 Good Distribution Practice (GDP) certificate (without technical assessment) $220 

Turnaround time

Turnaround time is 10 working days from the date of technical assessment completion / audit close out.

Note:Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Payment modes

Certificate of a Pharmaceutical Product

Fee

The application fee is $220.

Turnaround time

Turnaround time is 10 working days from the date of application.

Note: Turnaround time excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").

Payment modes

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