Chinese Medicine Regulatory Office

Chinese Medicine Ordinance

The Chinese Medicine Ordinance (Cap. 549) was enacted in 1999. It is currently the major part of the legal framework on regulating Chinese medicine in Hong Kong.

Regulation of Chinese Medicine Practice

  • According to the Chinese Medicine Ordinance, “practicing Chinese medicine” means any of the following act or activities: (a) the diagnosis, treatment, prevention or alleviation of any disease or any symptom of a disease; (b) the prescription of Chinese herbal medicines or proprietary Chinese medicines; (c) the regulation of the functional states of the human body, on the basis of traditional Chinese medicine in general practice, acupuncture or bone-setting, and “Chinese medicine practice” or “practice of Chinese medicine” shall be construed accordingly.
  • According to the Chinese Medicine Ordinance, any person who wishes to be registered as a registered Chinese medicine practitioner shall undertake and pass the Licensing Examination conducted by the Chinese Medicine Council of Hong Kong. To be eligible to undertake the Licensing Examination, one should have satisfactorily completed such undergraduate degree course of training in Chinese medicine practice or its equivalent as is approved by the Chinese Medicine Council of Hong Kong.

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.
  • Import and export control of Chinese medicines: According to the Import and Export Ordinance (Cap. 60), import or export of 31 Chinese herbal medicines in Schedule 1 and 5 Chinese herbal medicines in Schedule 2 (including: Flos Campsis, processed Radix Aconiti, processed Radix Aconiti Kusnezoffii, Radix Clematidis and Radix Gentianae), and proprietary Chinese medicines should apply a licence from the Department of Health.
  • Apart from the Chinese Medicine Ordinance, there are other ordinances related to Chinese medicines in Hong Kong, for example: