Amend a Therapeutic Product dealer'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.

Importer 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 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. The following are examples of amendments that require site inspection:

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

Amendments not requiring site inspection

The following amendments do not require site inspection:

  • Deletion of existing warehouse.
  • Addition or deletion of aspect of activities.
  • Addition or deletion of products (only for importer's licence).
  • Addition or deletion of Responsible Person.

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.
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.
Authorisation Letter from the product registrant, only applicable for products that are not registered under your company (only for importer's licence).
 Compulsory for addition of a new product not registered under your company.
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 Therapeutic Product 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

The following amendments require 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 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.
  • 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.
  • Addition of manufacturing activities of product comprising highly sensitising materials (e.g. penicillins, cephalosporins, hormones, steroids, etc.) or biologicals (including vaccines, blood products, preparations containing viruses and other micro organisms) or cytotoxic substances.

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.

Documents required

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

  • Updated Site Master File (SMF), the scanned copy of the document can be submitted as an attachment to the application.
    • Note: The SMF should be prepared in accordance with the Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a SMF, available from PIC/S Publication.
  • Certificate of Accreditation of the contract testing laboratory.
  • Letter of approval issued by the agency or institution that approves the use of the premises for the manufacturing and storage of health products.
  • Details of the dosage forms and products manufactured or assembled, including the name, strength and product licence number (if any). Also indicate if your company is acting as a contractor acceptor (i.e. manufactures partially or wholly for others) for these products.

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).