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