Responsibilities of Applicant 申请人的责任
Product Safety 产品的安全性
The applicant for the CPM product listing is responsible for the safety and quality of the CPM in the market. The applicant should ensure that the product meets all the legal requirements, and conforms to the standards and specifications of the product that have been submitted and approved by the HSA. In addition, the applicant 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.
The applicant 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 资料变更报告
After a company has been licensed, any subsequent change(s) in the particulars relating to the CPM or company will render the licence invalid unless prior approval of such change(s) has been obtained from the Health Sciences Authority. This includes any changes to the legal status of the product in the country of origin e.g. registration status, free sale status, classification.
Licence holders shall seek prior approval of the Health Sciences Authority to import / manufacture / assemble any new product.
Report of Adverse Drug Reaction 药品不良反应报告
Licence holders shall report to the Vigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way #11-03 Helios Singapore 138667, as soon as possible (within 7 days) upon receipt of any information of adverse drug reactions arising from the CPM which they are dealing.
Record Keeping 记录的保存
All licence holders must keep records of their transaction for a period of 2 years from the date of last entry.
Product Recall 中成药的回收
It is the responsibility of the licence holders to recall any product manufactured / assembled / imported / distributed by them when directed by the Health Sciences Authority for reasons of safety or poor quality.
Advertisement of CPM 中成药的广告
The advertisement and sales promotion of CPM require a permit from the Health Sciences Authority under the Medicines (Medical Advertisements) Regulations. Please note that the product listing approval of a CPM does not imply that the product name and/or its claims will be allowed for advertising purposes.
It is the responsibility of the applicant to refrain from using the CPM product listing approval as a marketing tool to advertise or promote the product.
Please refer to the Medical Advertisments section for more details.
Suspension, Revocation and Variation of Licence 执照的暂时吊销，撤消或更改
The Health Sciences Authority may suspend, revoke or amend the details in any licence or certificate. The Licensing Authority shall serve on the licence or certificate holder 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 shall be final.
Any person who contravenes any provision of the legislation on CPM is liable, to a fine of not more than $5000 or to an imprisonment of not more than 2 years or both.
任何人触犯任何中成药法律条文, 将被罚款不超过5000元 ,或监禁不超过两年, 或两者兼施。