Apply for new product listing

Learn about the process and how to apply for a new CPM product listing in Singapore.

Overview

You must first apply for a product listing before you import, manufacture or assemble your Chinese Proprietary Medicine (CPM) in Singapore. You will also need a product listing if you intend to apply for a  Certificate for Exporter of Chinese Proprietary Medicines (Free Sale Certificate) to facilitate the export of a CPM product out of Singapore.

For CPM that are imported solely for re-export, a product listing is not required. However, a permit to import for re-export of CPM is required.

Who can apply

You must be a locally registered company with the Accounting and Corporate Regulatory Authority (ACRA) to submit a new product listing application. As the applicant for the CPM product listing, you are responsible for the safety and quality of the CPM in the market.

Documents required

Imported products

Imported products

  1. Labels of product to be sold/supplied in Singapore which meet labelling requirements, including:
    • Inner label.
    • Outer label or carton (if any).
    • Package insert (if any).
  2. Labels of the product sold or supplied in the country of manufacture, including:
    • Inner label.
    • Outer label or carton (if any).
    • Package insert (if any).
  3. Photograph of product contents392 KB. Physical sample of product are to be submitted only upon request.
  4. Manufacturer's licence or certificate.
  5. Good Manufacturing Practice (GMP) certificate (if any).
  6. Product registration certificate. If this is not available, a valid Certificate for Exporter of CPM (Free Sale Certificate), Certificate of Pharmaceutical Product (CPP) or similar document is required.
  7. Test results of toxic heavy metals and microbial limits. Please refer to the test report requirements for more details.
  8. Test results of DEG and EG – for oral liquid products with glycerin, propylene glycol, or sorbitol solution.
  9. Description of manufacturing process. 
  10. General quality parameters information for the CPM product, including:
  11. Finished product specifications.
  12. Endorsement of product formula (including all active and inactive ingredients) by overseas manufacturer.
  13. Undertaking by overseas manufacturer that product does not contain any western drugs or active synthetic substances.
  14. Information on legal classifications of product in countries of sales63 KB.
  15. Website undertaking80 KB (for product with website stated on label).
  16. Transmissible Spongiform Encephalopathy (TSE) undertaking19 KB (for product containing materials (including those used for making capsule shells) derived from ruminants e.g. cattle, buffalo, sheep, goat, deer, antelope).
  17. Information required for fermented substances113 KB (for product containing fermented substance e.g. Cordyceps, Red Yeast Rice).

Locally manufactured products

Locally manufactured products

  1. Labels of the product to be sold/supplied in Singapore which meet labelling requirements, including:
    • Inner label
    • Outer label or carton (if any)
    • Package insert (if any)
  2. Photograph of product contents392 KB. Physical sample of product are to be submitted only upon request.
  3. Test results of toxic heavy metals and microbial limits. Please refer to the test report requirements for more details.
  4. Test results of DEG and EG – for oral liquid products with glycerin, propylene glycol, or sorbitol solution.
  5. Description of manufacturing process.
  6. General quality parameters information for the CPM product, including:
  7. Finished product specifications.
  8. Website undertaking80 KB (for product with website stated on label).
  9. Transmissible Spongiform Encephalopathy (TSE) undertaking19 KB (for product containing materials (including those used for making capsule shells) derived from ruminants e.g. cattle, buffalo, sheep, goat, deer, antelope).
  10. Information required for fermented substances113 KB (for product containing fermented substance e.g. Cordyceps, Red Yeast Rice).

Ensure your submitted documents are signed by the correct signatories136 KB.

Note: In addition to the above items, we may request for other information relevant to your application.

If this is the first time you are submitting a CPM product listing application, you are advised to email us to arrange for a pre-submission consultation.

Product listing fees

You do not need to pay a fee.

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).

Turn-around-time

The turn-around-time for new product listing applications is 60 working days, excluding the time taken by you to respond to our request for clarification or additional information (applicant's stop-clock).

Listing process

Process Description

Step 1: Verification

 A CPM listing application is submitted to us and the Verification Officer (VO) screens the application form and attachments for completeness and basic irregularities. If irregularities are found, the VO would raise Input Requests to seek your clarification. If the application is found to be generally complete at this initial stage, the VO would submit it for evaluation.

Step 2: Evaluation

 The Evaluation Officer (EO) reviews the technical aspects of the application, including test reports, substantiation of label claims and manufacturing process. Input Requests may also be raised by the EO, until the final recommendation for approval or rejection of the application is made.

Step 3: Regulatory decision

 The Approving Officer (AO) assesses the recommendation by the EO against the information submitted in the application and formally issues the approval or rejection notification to you. The AO could also request for further clarification by sending the application back to the EO, who would then raise an Input Request to you accordingly. When you resubmit the application, the process from Steps 2 to 3 is repeated, until the AO issues the final regulatory outcome.

Note: We strive to meet the turn-around-time for all submitted applications. You should ensure that the applications and replies to Input Requests are complete before submission, to prevent unnecessary delays to the processing due to incomplete information and untimely responses.

To complement the CPM Guidelines, a list of questions and answers on the controls on CPM, safety and quality, claims and labelling of CPM can be found here150 KB