Chinese Medicine Regulatory Office

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Regulation of Chinese Medicines

• According to the Chinese Medicine Ordinance, Chinese herbal medicines mean Chinese herbal medicines specified in Schedule 1 and Schedule 2 of the Ordinance.
• According to the Chinese Medicine Ordinance, proprietary Chinese medicine means any proprietary product:
  (a) composed solely of the following as active ingredients:

    (i) any Chinese herbal medicines,

    (ii) any materials of herbal, animal or mineral origin customarily used by the Chinese; or

    (iii) any medicines and materials referred to in subparagraphs (i) and (ii) respectively;
  (b) formulated in a finished dose form; and
  (c) known or claimed to be used for the diagnosis, treatment, prevention or alleviation of any disease or any symptom of a disease in human beings, or for the regulation of the functional states of the human body.
• The licensing of Chinese medicines traders: Chinese medicines traders who wish to engage in the business of retail and wholesale of Chinese herbal medicines as well as the wholesale and manufacturing business of proprietary Chinese medicines must first apply for the relevant licence from the Chinese Medicine Council of Hong Kong. They may continue operating their own business only after they have obtained the licence.
• The registration of proprietary Chinese medicines: According to Section 119 of the Chinese Medicine Ordinance, no person shall sell, import or possess any proprietary Chinese medicine unless the proprietary Chinese medicine is registered under the Chinese Medicine Council of Hong Kong.
• Proprietary Chinese medicine must with label and package insert: According to Section 143 and 144 of the Chinese Medicine Ordinance, no person shall sell or possess any proprietary Chinese medicine unless the package of the proprietary Chinese medicine is labelled and with a package insert. For details about the requirement of label and package insert, please refer to Section 26-28 of the Chinese Medicines Regulation.