Licensing and Certification of Importers and Wholesalers

  3. Amend an active ingredient importer’s or wholesaler’s licence

Amend an active ingredient importer’s or wholesaler’s licence

You must submit an amendment application for changes to your approved licence such as company or applicant details, scope of activities and premises.

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.

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 quality of the active ingredient(s). 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 active ingredients.
  •  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 assessment, there may be cases where technical assessment is required 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.

Pharmacist Practising Certificate, only applicable when the Responsible Person is a registered pharmacist.

Compulsory for addition of a new Responsible Person or change of the current Responsible Person to a new person who is a registered pharmacist.

List of active ingredients to be added.

If applicable.

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.

Store approval letter.

If applicable.

Contract with contract acceptor for outsourced activity which clearly establishes the roles and responsibilities of each party.

If there is a change in contract acceptor or outsourced activity.

Other supporting documents.

If applicable.

 

Fees and turnaround time

Refer to active ingredient licence and certificate 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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