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This application is a service of the Singapore Government.

Health Sciences Authority

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. 

中成药产品的申请人须对产品的安全和质量负责。申请人应确保产品符合所有的法律要求以及HSA批准的标准和规格。此外,申请人应确保可能存在于产品的农药残留或其他环境污染物不会对消费者构成任何危险。

 

Adulteration 掺杂

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. 

若中成药产品被发现掺杂《毒药法令》中所列有的成份或其它活性合成物质,中成药产品的申请人须承担全部责任。

 

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.

凡领有执照的公司,如中成药或公司的有关资料有所更改,必须事先获得执照签发当局的批准。否则, 原有执照可能作废。

执照持有人必须先获得执照签发当局的批准,才能进口、制造或分装/包装任何新产品。

 

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.

The Adverse Drug Reaction Report Form and more details can be found in the Safety Information and Recalls section. 

执照持有人在接获任何有关其经营的药品有不良反应的情报时,应尽快(于7天内)向卫生科学局医疗保健产品管理司警戒与条例遵循组报告。有关填交不良反应报告表的相关信息,请点击此处

 

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.

所有执照持有人必须保存其交易记录两年,由最后记录日期算起。

 

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.

当卫生科学局基于安全或品质欠佳理由发出指示时,所有执照持有人均有责任回收他们所制造、分装、进口或批发的药品。

 

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.

依照药物(医药广告)条例,中成药的广告及促销必须获得卫生科学局发出的准证。在本地登记的中成药,其药品名称和标签上的声称并不一定会被允许用于广告用途。

申请者也须确保不把中成药产品登记批准作为广告或促销的用途。

有关中成药广告的相关信息,请点击此处

 

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. 
 

卫生科学局有权暂时吊销,撤消或更改任何执照或证书。暂时吊销、撤消或更改的详情及理由,将以书面通知执照或证书持有人。任何人不服上述决定,可向卫生部长上诉。卫生部长拥有最终的决定权。

 

Penalty 处罚

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。