Formula granules for Chinese medicine (commonly known as ‘Chinese medicine granules’) are standardised granules made by extracting, concentrating and drying traditional Chinese herbal medicines and decoction pieces using modern technology. In Hong Kong, they are treated as a special form of Chinese medicine and are regulated between traditional Chinese herbal medicines and proprietary Chinese medicines. To trade in these products, you need a wholesaler’s and/or retailer’s licence for Chinese herbal medicines. However, because their production involves complex extraction and formulation processes, the Chinese Medicine Council of Hong Kong applies higher quality standards. Suppliers must be able to provide detailed quality documentation demonstrating that their granules meet Hong Kong standards for identification, content, pesticide residues, heavy metals and other aspects.
HONG KONG DRUG LICENSING
How is the regulation of “Chinese medicine granules” different from that of traditional Chinese herbal decoction pieces? What licence do I need to operate?
A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.
Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.
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