Apply for a Chinese Proprietary Medicine dealer's licence

You must apply for a licence to import, wholesale or manufacture Chinese Proprietary Medicine in Singapore.

Import and wholesale dealer's licence

Application submission

For import licence, you are required to obtain at least an in-principle approval for CPM product listing application before applying for import licence for CPM. Issuance of the import licence for CPM is subject to the approval of CPM product listing and the satisfactory close-out of GDP audit.

Companies which are importing CPM solely for the purpose to re-export to another country do not need to apply for an import licence. However, you will need to apply for an import for re-export of CPM permit. 

Documents required 

You need to submit the following documents:

  1. Current layout plan for the premises, specifying the storage areas.
    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.
  2. Good Distribution Practice Standard Operating Procedure.
  3. Good Distribution Practice records or recording templates.
  4. Contract with contract acceptor for outsourced activity which clearly establishes the roles and responsibilities of each party (if any).

Fees and turnaround time

Refer to Chinese Proprietary Medicine dealer's licence fees and turnaround time for more information.

Good Distribution Practice audits

Compliance with Good Distribution Practice (GDP) standard is mandatory for all CPM importers and wholesalers.

When your licence application is received, we will inform you on the date for a GDP audit of your premises.

The licence will only be approved and issued 10 working days from the date of audit close out if your company is found to have complied with the required GDP standard.

After licence approval, regular routine audits will be conducted to assess your company's continued compliance. The frequency of the routine audits will depend on risk factors like the activities conducted by your company, and your level of compliance with the regulatory requirements. Unannounced audits may also be conducted. 

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

Application submission 

Documents required

You need to submit the following documents:

  • Site Master File.
    • This is a mandatory requirement and the scanned copy of the document can be submitted as an attachment to the application.
    • The Site Master File should be prepared in accordance with the PIC/S Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File.
  • Certificate of Accreditation of the contract testing laboratory, if any.
  • Letter of approval issued by the agency or institution that approves the use of the premises for
    the manufacturing and storage of health products, if applicable.
  • Details of the dosage forms and products manufactured and assembled.
    • 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 Chinese Proprietary Medicine dealer's licence fees and turnaround time for more information.

Good Manufacturing Practice audits

Compliance to Good Manufacturing Practice (GMP) standard is mandatory for all CPM products manufacturers, including assemblers.

When your licence application is received, we will contact your company to arrange for a pre-approval audit. A pre-audit letter will be sent to inform you of the date of GMP audit.

Your Site Master File (SMF) should be prepared in accordance with the Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) available from the PIC/S Publication website. The following topics need to be addressed in your SMF:

  • General Information
  • Pharmaceutical Quality System
  • Personnel
  • Premises & Equipment
  • Documentation
  • Production
  • Quality Control
  • Outsourced Activities
  • Complaints and Product Recall
  • Self-Inspection

A manufacturer’s licence would only be issued 10 working days from date of audit close out, if your company has been found to have complied with the required GMP standards.

After licence approval, regular routine audits will be conducted to assess your company’s continued compliance. The frequency of the routine audit would depend on risk factors like the activities conducted by your company and your compliance level with the regulatory requirements. Unannounced audits may also be conducted.

Additional Information For Manufacturers

1. Updates on Licence Application to Manufacture CPM products

This presentation delivered at the Complementary Health Products (CHP) Industry Training Workshop 2021 on 4 October 2021 provides information on the licence application to manufacture CPM products. These information include:

  • An overview on Manufacturer’s Licence statutory and regulatory requirements,

  • Requirements for Responsible Persons named in the Manufacturer’s Licence,

  • Requirements for contract testing laboratory named in the Manufacturer’s Licence, and

  • New dosage form selection (‘All Dosage Form’) available for secondary packaging (assembly) activities

Updates on Manufacturer’s Licence Application for CPM_4 Oct 20211119 KB

2. Microbiological Testing of CPM products and GMP Requirements for Microbiological Testing laboratory

Controlling the microbiological limits of CPM products is important for ensuring the quality of product and the consumers’ health. This presentation delivered at the CHP Industry Training Workshop 2021 provides information on:

  1. Microbiological control necessary for CPM products
  2. Understanding the compendial microbiological tests applicable for CPM products
  3. GMP requirements for in-house microbiological testing laboratory and contract agreement with 3rd party laboratories, and
  4. Investigation of microbiological Out of Specification (OOS) result and follow-up actions

Microbiological Testing of CPM products and GMP Requirements for Microbiological Testing lab_4 Oct 20211096 KB

3. Guidance On Secondary Packaging Of Therapeutic And Medicinal Products

A new guide has been published to provide guidance for secondary packagers in the interpretation of the principles and guidelines of GMP in the PIC/S Guide to GMP with respect to the secondary packaging of finished products.

Guidance on Secondary Packaging of Therapeutic and Medicinal Products (GUIDE-MQA-031)455 KB

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).