Importing Healthcare Products into Singapore Part 3: Importing Chinese Medicine
This guide provides a brief snapshot of the various regulations and requirements for importing Chinese Proprietary Medicine (CPM) into Singapore. For a general overview of the regulatory regime for importing healthcare products, refer to Importing Health Care Products into Singapore – An Overview. Note that this is neither a comprehensive compilation of requirements nor a professional advice but only a broad overview.
“Chinese Proprietary Medicine” refers to any medicinal product used in the system of therapeutics according to the traditional Chinese method, and contains one or more active substances, all of which are derived wholly from plants, animals or minerals or a combination of any one or more of them. The medicinal product or all of its active substances should be described in the current edition of “A Dictionary of Chinese Pharmacy”, “The 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 the Poisons List in 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.
The 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 with HSA’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:
- Particulars of company
- Particulars of person making application on behalf of company
- Store layout plan
- Product Approval Application – the applicants must provide a list of products that they intend to import and allowed to deal in approved products.
Note that importers must submit documents showing absence of western drugs, and test results of toxic heavy metals and microbial contents for every consignment of CPM imported.
Dealers must apply to the Health Sciences Authority for approval to import CPM products solely for the purpose of re-export at least one week before the import.
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
- General Product details
- Ingredients details
- Overseas assembler details
- Manufacturer details
Application for product approval must be accompanied by:
- Labels of products sold in Singapore
- Labels of products sold in country of manufacture
- Manufacturer’s License
- Certificate of GMP, if available
- Product Registration certificate for products from China
- Free Sale certificate or its equivalent
- Test results of toxic heavy metals and microbial contents
- Storage conditions/containers
- Information on Legal classification in countries where the product is on sale
- Endorsement of product formula (including all active and inactive ingredients) by overseas manufacturer and undertaking by overseas manufacturer that product does not contain any Western drugs or active synthetic substances
GENERAL OBLIGATIONS OF IMPORTERS
Generally, CPM dealers must ensure compliance with the following requirements:
- The CPM must not contain:
- Any substances Scheduled in the Poisons Act
- Any synthetic drugs
- Amygdalin, pangamic acid or its salts, danthron, suprofen or its salts and rhodamine B；
- Any other substances except those stated on the labels
- The CPM must not exceed the limits set for
- Toxic heavy metals
- Microbial contamination
- The 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: