Amend a CTGTP dealer's licence

You must submit an amendment application for changes to your approved licence such as the scope of activities.

Amendment to licence details

An amendment application must be submitted when there are changes to your approved licence details, such as scope of activities and premises.

Importer's and wholesaler's licence

If you intend to change your importer's licence granted for full scope activities to one that is solely for restricted activities, or vice versa, you will need to cancel your existing licence and submit a new licence application.

Amendments requiring technical assessment 

Technical assessments, including site inspections, may be conducted by HSA for certain amendments such as those that would have direct impact on the product's quality. The following are examples of amendments that require technical assessment:

  • Inclusion of new warehouse or change in location or address of the current warehouse for the storage of CTGTP.
  • Inclusion of new storage conditions to the warehouse, such as cold chain storage.

Amendments not requiring technical assessment 

The following amendments do not require technical assessment:

  • Deletion of existing warehouse.
  • Addition or deletion of aspect of activities.
  • Addition or deletion of Responsible Person.

Note: While these amendments generally do not require technical assessments, there may be cases where technical assessment is deemed necessary.

Documents required

  1. Relevant procedures such as handling of CTGTP products
  2. Updated floor layout plan

Manufacturer's licence

Amendments requiring technical assessment

Technical assessment, which may include site inspection, may be conducted by HSA for certain amendments such as those that would have direct impact on the product's quality.

Examples of amendments which require technical assessments:

  • Addition to manufacturing operations (Example: scope of activities, type of CTGTP manufactured, secondary packaging, type of quality control testing).
  • Addition or amendment of manufacturing site address.
    • Each manufacturer's licence is issued to each company with a specific manufacturing address and postal code. If your company is relocating the manufacturing premise to a different address i.e. postal code, you have to apply for a new manufacturer's licence instead.
    • Your company may file for amendment application if there is addition or relocation of manufacturing activities within the approved building such as addition of unit or floor, or postal code.

Amendments not requiring technical assessment

Examples of amendments which do not require technical assessment:

  • Deletion of approved manufacturing operations (type of dosage form, type of CTGTP manufactured).
  • Deletion of approved manufacturing site address (if there is more than one manufacturing site address).
  • Amendment of responsible person for production or quality operations.

Note: While these amendments generally do not require technical assessments, there may be cases where technical assessment is deemed necessary.

Fees and turnaround time

Refer to CTGTP fees and turnaround time for more information.

How to apply

Submit your applications through SHARE.