Question

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.

Answer 1

1. General quality parameters information for the CPM product, including:
   • Storage conditions (form)123 KB. Refer to our guide on storage conditions494 KB for more details.
   • Physical characteristics of the product such as colour, taste, smell, shape, size of capsule, and can be included in the product's Certificate of Analysis (COA) or as a separate document.
   • Physical specifications214 KB of the product. This can be included in the product's COA or as a separate document.
2. Endorsement of product formula (including all active and inactive ingredients) by overseas manufacturer.
3. Undertaking by overseas manufacturer that product does not contain any western drugs or active synthetic substances.
4. Information on legal classifications of product in countries of sales63 KB.
5. Website undertaking80 KB (for product with website stated on label).
6. 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).
7. Information required for fermented substances113 KB (for product containing fermented substance e.g. Cordyceps, Red Yeast Rice).

Comments

https://www.hsa.gov.sg/chinese-proprietary-medicines/listing/apply

Answer 2

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.

Comments

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