Responsibilities of a CPM dealer

Product safety and quality

You are responsible for the safety and quality of the CPM in the market. You should ensure that the product:

• Meets all the legal requirements.
• Conforms to the standards and specifications of the product that have been submitted and approved by HSA.
• Remains stable and safe for use during the period of proposed shelf-life. The shelf-life of a product is determined by the product formulation, packaging and storage conditions and the proposed shelf-life should be supported by evidence.

In addition, you should ensure that the levels of pesticides and/or other environmental contaminants that could be present in the product have been scientifically assessed not to pose any dangers to the intended users.

Adulteration

You shall take full responsibility should the CPM product be found adulterated with substances listed under the Poisons Act, and/or active synthetic substances.

Report of changes in particulars

After a company has been licensed, any subsequent changes in the particulars relating to the CPM or company will render the licence invalid unless prior approval of such changes have been obtained from HSA.

This includes any changes to the legal status of the product in the country of origin, such as registration status, free sale status or classification.

Report of adverse drug reaction

You should report to our Vigilance & Compliance Branch as soon as possible (within 7 days) upon receipt of any information of adverse drug reactions arising from the CPM which you are dealing with. Refer to our guide on how to report adverse events of health products.

Record keeping

You must keep records of all transactions for a period of two years from the date of last entry.

Product recall

It is your responsibility to recall any product manufactured, assembled, imported or distributed by you when directed by HSA for reasons of safety or poor quality.

Advertisements and promotions

You will require a valid permit from us before publishing any medical advertisements or conducting any sales promotion activities directed to the general public.

Refer to our advertisements and promotions guidelines for more information on what is required of you before you run any advertisements and promotions for your products.

Submission of Documents for Every Consignment at Point of Import

All CPM import licence holders are reminded that the following documents are required to be submitted to the Complementary Health Products Branch (CHPB) for the import of every consignment of the CPM:

(a) Supplier’s invoice with the following (either in print or legible handwriting):

• the CPM import licence number (at the top right hand corner of the invoice) and
• the CPM product reference number and batch number for each product (next to the corresponding product name)

(b) A declaration on the absence of any poisons as defined in the Poisons Act (Cap. 234) and any active synthetic substance in the CPM

(c) Test results of toxic heavy metals

(d) Test results of microbial contamination

(e) Other documents and test results as may be required by the licensing authority

(f) Notification of CPM Import and Test Report Submission41 KB

The required documents (a) to (f) are to be submitted within 2 months of import to the CHPB by email: HSA_CPM@hsa.gov.sg. You shall receive an acknowledgement from the CHPB within 1 month from the date of submission of the required documents if they are in order. It is advisable for you to retain the acknowledgement from CHPB till the expiry of the CPM. Please note that there should be no sale / supply of the imported CPM unless and until the required test reports with satisfactory results are submitted.

Please be reminded that non-submission or late submission (exceeding 2 months of import) of the required documents is an offence under the Medicines (Licensing, Standard Provisions and Fees) Regulations.

Suspension, revocation and variation of licence

HSA may suspend, revoke or amend the details in any licence or certificate. HSA will serve you a notice giving particulars and reasons for such suspensions, revocation or variation. Any person who is aggrieved by such a decision may appeal to the Minister for Health, whose decision will be final.

Penalty

Anyone who contravenes any provision of the legislation on CPM is liable, to a fine of not more than $5,000 or to an imprisonment of not more than two years, or both.