将医疗保健产品导入新加坡第3部分：进口中医
本指南规定了将中国专有医学（CPM）进入新加坡的各种规定和要求的简要快照。有关进口医疗产品的监管制度概述，请参阅Importing Health Care Products into Singapore – An Overview。请注意，这既不是全面汇编要求，也不是专业建议，而只是广泛的概述。
“中国专有药”是指根据中文方法治疗方法中使用的任何药品，并含有一种或多种活性物质，所有这些都是从植物，动物或矿物或任何一个或任何一个的组合衍生的更多的更多。医药产品或其所有活性物质应在当前版本的“中国药房”，“的Chinese Herbal Medicine Materia Medica” or such other publication as may be approved by the Minister, but shall not include:
- any medicinal product to be injected into the human body;
- any item specified in thePoisons Listin the Schedule to the Poisons Act or
- any medicinal product which contains as an active substance any chemically defined isolated constituents of plants, animals or minerals or a combination of any one or more of the aforementioned.
的CPM must be listed and approved for sale in Singapore prior to importation. Companies applying for the Import Licence for CPM would need to demonstrate their compliance withHSA’s GDP standard。
If the products are imported for the purpose of selling to others for re-selling, the company would need a Wholesale Dealer’s Licence for Chinese Proprietary Medicines.
IMPORT LICENSE
Application for CPM Import license must be made online accompanied by the following:
- 公司的细节
- Particulars of person making application on behalf of company
- 商店布局计划
- Product Approval Application – the applicants must provide a list of products that they intend to import and allowed to deal in approved products.
请注意，进口商必须提交显示缺乏西方药物的文件，以及对进口CPM的每批寄售有毒重金属和微生物含量的测试结果。
经销商必须申请卫生科技机构批准，仅用于进口CPM产品，以便在进口前至少一周再出口。
PRODUCT APPROVAL APPLICATION
CPM importers are also required to obtain product approvals for the CPM products dealt by them.
Application must provide the following information:
- Company Particulars
- Applicant particulars
- 一般产品详细信息
- Ingredients details
- 海外汇编详情
- Manufacturer details
Application for product approval must be accompanied by:
- Labels of products sold in Singapore
- Labels of products sold in country of manufacture
- 制造商的许可证
- GMP证书，如有可用
- 来自中国产品的产品注册证书
- 免费销售证书或其等价物
- Test results of toxic heavy metals and microbial contents
- Storage conditions/containers
- 有关产品在销售的国家法律分类的信息
- 通过海外制造商的产品配方（包括所有活性和无活性成分）的认可，并由海外制造商承诺该产品不含任何西方药物或活性合成物质
GENERAL OBLIGATIONS OF IMPORTERS
Generally, CPM dealers must ensure compliance with the following requirements:
- CPM不得包含：
- Any substances Scheduled in the Poisons Act
- Any synthetic drugs
- Amygdalin, pangamic acid or its salts, danthron, suprofen or its salts and rhodamine B；
- 除了标签上的任何其他物质
- 的CPM must not exceed the limits set for
- 毒性重金属
- Microbial contamination
- 的CPM must meet labeling requirements and the labels and packaging materials refrain from mentioning any of the 19 diseases/conditions specified in the First Schedule of the Medicines Act. Examples are cancer, diabetes, hypertension and sexual function, etc.
- Any advertisements and sales promotion must be approved via a permit from the Health Sciences Authority.
For information about importing other types of healthcare products into Singapore, refer to the following guides: