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Amend a Chinese Proprietary Medicine dealer's licence

You have to apply to amend an approved dealer's licence if there are changes to be made to the details of your company.

Amendment to company or applicant details

You may amend your company's information in order to change particulars such as company name and address, provided there is no change to the company's Unique Entity Number (UEN). For change in UEN, you will need to apply for a new CRIS account and thereafter submit a new application.

You may also amend the applicant's details for licences and applications, such as name and contact details.

Note: Amendments to company or applicant details will affect all registrations and licences your company has with us. There are no fees for such amendments.

Amendment to licence details

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

Import and wholesale dealer's licence

Amendments requiring site inspection

Site inspections may be conducted by us for certain amendments such as those that would have direct impact on the product's quality.

An example of an amendment that requires site inspection is the inclusion of a new warehouse or change in location or address of the current warehouse for the storage of Chinese Proprietary Medicines.

Amendments not requiring site inspection

An amendment that does not require site inspection is the deletion of an existing warehouse.

Note: While these amendments generally do not require site inspection, there may be cases where we may still conduct one if it is deemed necessary.

Documents required

You need to submit the following documents in English, where applicable:

Supporting documents Details
Current layout plan for the premises, specifying the storage areas.

Compulsory for addition of a new warehouse or change in location or address of current warehouse.

The layout floor plan will need to have the following information:
(i) The full address of the warehouse
(ii) The dimensions (length and width) of the warehouse
(iii) Indication of various storage areas, e.g. receiving bay, quarantined product area, released product area, rejected product area, returned product area, recalled product area, outgoing staging area, etc.
Good Distribution Practice (GDP) standard operating procedures, which must be up-to-date. If applicable.
GDP records or recording templates, which must be up-to-date. If applicable.
 Contract with contract acceptor for outsourced activity which clearly establishes the roles and responsibilities of each party  If there is change in contract acceptor or outsourced activity.

Fees and turnaround time

Refer to Chinese Proprietary Medicine dealer's licence 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).

Manufacturer's licence

Amendments requiring site inspection

  • 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, 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.
  • Addition or amendment of warehouse address, including addition of third party logistic warehouse.
  • Addition of cold-chain activities.
  • Addition or amendment of manufacturing activities (i.e. manufacture or primary assembly or secondary assembly) for approved dosage forms.

Amendments not requiring site inspection

The following amendments do not require site inspection:

  • Amendment of person in-charge of production or quality control.
  • Addition, amendment or deletion of contract testing laboratory address or type of analytical test performed.
  • Deletion of approved manufacturing site address or warehouse address.
  • Deletion of approved manufacturing activities or dosage form.
  • Addition or new dosage forms for secondary assembly.

Note: While these amendments generally do not require site inspection, there may be cases where we may still conduct one if it is deemed necessary.

Fees and turnaround time

Refer to Chinese Proprietary Medicine 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).

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