FAQ

1. 

About the Chinese Medicine Ordinance

Q :

When was the Chinese Medicine Ordinance passed?

A :

The Chinese Medicine Ordinance (Cap. 549 of the Laws of Hong Kong) was passed by the Legislative Council on 14 July 1999.

2. 

About the Chinese Medicine Council of Hong Kong

Q :
When was the Chinese Medicine Council set up? What is its composition?
A :

The Chinese Medicine Council was set up in September 1999. Its members include Chinese medicine professionals and traders, persons from educational or scientific research institutions, lay persons and government officials appointed by the Chief Executive.

Q :
What is the main function of the Chinese Medicine Council?
A :

The main function of the Chinese Medicine Council is to carry out and implement the regulatory measures for Chinese medicine as stipulated in the Chinese Medicine Ordinance. Regulation of Chinese medicine practitioners includes registration, examination and discipline of Chinese medicine practitioners, whereas regulation of Chinese medicines includes licensing of Chinese medicines traders and registration of proprietary Chinese medicines.

Q :

What is the address of the Chinese Medicine Council?

A :

The address of the Chinese Medicine Council is :

22/F Wu Chung House
213 Queen's Road East
Wanchai
Hong Kong
Enquiry no. : 2121 1888
Fax no. : 2121 1898

3. 

About Regulation of Chinese medicines

Q :
What are the regulatory measures for Chinese medicines?
A :

The Chinese Medicine Council is formulating details of the regulatory measures for Chinese medicines. The regulatory measures for Chinese medicines include the licensing of wholesale dealers and retailers in Chinese herbal medicines, licensing of wholesale dealers and manufacturers in proprietary Chinese medicines and registration of proprietary Chinese medicines. In order to minimize inconvenience caused to the trade of Chinese medicines, transitional arrangements are stated in the Chinese Medicine Ordinance to allow traders and manufacturers of Chinese medicines continue operating before the issuing of licences and the proprietary Chinese medicines being registered.

Q :

What are the procedures of importing proprietary Chinese medicines from places outside Hong Kong?

A :

Currently, one should apply for an import and export licence for import of proprietary Chinese medicines. Please contact the Chinese Medicines Section, Chinese Medicine Division, Department of Health at 3904 9227 / 2319 5119 for enquiries. After implementation of the registration of proprietary Chinese medicines, only proprietary Chinese medicines registered with the Chinese Medicines Board of the Chinese Medicine Council are allowed to be imported.

4. 

About Promotion materials on Chinese medicine

Q :

What promotion materials on Chinese medicine can be obtained?

A :

The following information on Chinese medicine are available at the Department of Health:

  • Regulation of Chinese Medicine (poster & leaflet)
  • Treatment modalities of Chinese medicine, Health preservation in Chinese medicine, Information on taking Chinese medicines, Information on toxic and potent Chinese herbal medicines, Information on how to purchase Chinese medicines and Preparing herbal decoctions (leaflet)

Members of the public may obtain the publications from :

Chinese Medicine Division
Department of Health
16/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon

Enquiry Hotline : 2574 9999
Fax. no : 2123 9566

5. About the registration of proprietary Chinese medicines

  1. What are proprietary Chinese medicines (pCms)
  2. About the application for registration of proprietary Chinese medicines
  3. Factors relevant to determination of application for registration
  4. Duration for registration of pCm
  5. Variation of registered particulars of registered pCm
  6. About the de-registration of pCm
  7. Publication of registered pCms
  8. Certified copy of certificate of registration
  9. About the arrangement for transitional registration of pCms
  10. About clinical trials and medicinal tests of proprietary Chinese medicines
  11. About the Certificate of sale of proprietary Chinese medicines
  12. Requirements for Proprietary Chinese Medicine Labels and Packaging Inserts
  13. Exemptions Relating to Registration of Proprietary Chinese Medicine
  14. Registration Information for Proprietary Chinese Medicine
  15. Other Provisions

6. Application for Licence of Chinese Medicines Traders

  1. Application for Licence of Chinese Medicines Traders
  2. Retailer of Chinese Herbal Medicines
  3. Wholesaler of Chinese Herbal Medicines
  4. Wholesaler of Proprietary Chinese Medicines (pCm)
  5. Manufacturer of pCm
  6. Certificate for Manufacturer (Good Manufacturing Practice) (GMP)
7. 

About Other Issues

Q :
Is is necessary for a Chinese medicines trader that participates in a Chinese herbal medicines tradeshow to apply for a licence? What are the application procedures?
A :

According to the Chinese Medicine Ordinance (the Ordinance), Chinese medicines traders who wish to carry on a business in the retail of Chinese herbal medicines, wholesale of Chinese herbal medicines, wholesale of proprietary Chinese medicines or manufacturing of proprietary Chinese medicines shall first apply for a licence from the Chinese Medicines Board under the Chinese Medicine Council of Hong Kong (hereinafter known as "the Chinese Medicines Board"). Pursuant to the spirit of the Ordinance and to facilitate traders to take part in Chinese medicines tradeshows, the Chinese Medicines Board has formulated the requirements concerning arrangements for Chinese medicines traders to engage in Chinese medicines tradeshows. The details are set out in "Licensing arrangements of Chinese herbal medicines tradeshow licence (For traders' reference)".

Q :
How should a pCm wholesaler deal with pCms whose shelf-life has expired?
A :
  • pCm whose shelf-life has expired should not be sold or distributed
  • Proper handling like returning to manufacturer
  • To dispose pCms, the pCm wholesaler has to apply to Environmental Protection Department (EPD) for registration as a Chemical Waste Producer. The registration process involves two steps. The first step is to complete a registration form and return it to EPD. The second step is to pay the registration fee. A certificate with a waste producer (WP) number would be issued to the applicant. The registration form (Form EPD-129) can be obtained from EPD offices or downloaded from EPD web-site at http://www.epd.gov.hk/epd.
  • Contact one of the authorized chemical waste collectors. The list of authorized collectors for General Chemical Waste can be obtained from EPD web-site at http://www.epd.gov.hk/epd.
  • For enquires, please contact Environmental Protection Department at 2838 3111
  • Chinese medicines traders who wish to dispose of dangerous goods, or pCm containing tremolitum or actinolitum (both are asbestos-related substances), and their related materials shall seek further advice from EPD before contacting a chemical waste collector.
  • Chinese medicines traders may also take reference of the "Supplementary guidelines on disposal of unserviceable / expired/recalled Chinese medicine products for Chinese medicines traders"
Q :
How should a pCm manufacturer deal with the pCms whose shelf-life has expired?
A :
  • pCm whose shelf-life has expired should not be sold or distributed
  • To dispose pCms, the pCm manufacturer has to apply to Environmental Protection Department (EPD) for registration as a Chemical Waste Producer. The registration process involves two steps. The first step is to complete a registration form and return it to EPD. The second step is to pay the registration fee. A certificate with a waste producer (WP) number would be issued to the applicant. The registration form (Form EPD-129) can be obtained from EPD offices or downloaded from EPD web-site at http://www.epd.gov.hk/epd.
  • Contact one of the authorized chemical waste collectors. The list of authorized collectors for General Chemical Waste can be obtained from EPD web-site at http://www.epd.gov.hk/epd.
  • For enquires, please contact Environmental Protection Department at 2838 3111.
  • Chinese medicines traders who wish to dispose of dangerous goods, or pCm containing tremolitum or actinolitum (both are asbestos-related substances), and their related materials shall seek further advice from EPD before contacting a chemical waste collector.
  • Chinese medicines traders may also take reference of the "Supplementary guidelines on disposal of unserviceable / expired/recalled Chinese medicine products for Chinese medicines traders"
Q :
How should Chinese medicines traders dispose proprietary Chinese medicines (pCm) or Chinese herbal medicines (Chm)?
A :
  • Apply to the Environmental Protection Department (EPD) for registration as a Chemical Waste Producer. The registration process involves two steps. The first step is to complete a registration form and return it to EPD. The second step is to pay the registration fee. A certificate with a waste producer (WP) number would be issued to the applicant. The registration form (Form EPD-129) can be obtained from EPD offices or downloaded from EPD web-site at http://www.epd.gov.hk/epd.
  • Contact one of the authorized chemical waste collectors. The list of authorized collectors for General Chemical Waste can be obtained from EPD web-site at http://www.epd.gov.hk/epd.
  • For enquires, please contact EPD at 2838 3111.
  • Chinese medicines traders who wish to dispose of dangerous goods, or pCm containing tremolitum or actinolitum (both are asbestos-related substances), and their related materials shall seek further advice from EPD before contacting a chemical waste collector.
  • Chinese medicines traders may also take reference of the "Supplementary guidelines on disposal of unserviceable / expired/recalled Chinese medicine products for Chinese medicines traders"
Q :
What are the limits of pesticide residues in Chinese herbal medicines?
A :
  • Under the market surveillance system, the Department of Health will draw samples of Chinese herbal medicines from the market on a regular basis for testing for pesticide residues. The testing is undertaken by the Government Laboratory (GL). The GL will first conduct primary testing on the samples of Chinese herbal medicines. If excessive pesticide residues are detected in the samples, second-stage testing, i.e. testing for pesticide residues in the decoctions of the Chinese herbal medicine samples concerned, will be carried out so as to simulate the circumstances of human consumption.
  • The current limits of pesticide residues in Chinese herbal medicines set by the Chinese Medicine Council of Hong Kong (CMC) are based on the concentration detected in the samples of Chinese herbal medicines. The Chinese herbal medicines must not exceed the maximum residue limits of organochlorine pesticides concernednote (see Table 1). In general, no organophosphate pesticide residues are allowed in Chinese herbal medicines (see Table 2).

Table 1: Limits of organochlorine pesticide residues

Chinese name English name Test parameters Maximum
residue limit
(mg/kg)
1. 艾氏劑及狄氏劑 Aldrin & Dieldrin Sum of Aldrin and Dieldrin 0.05
2. 氯丹 Chlordane Sum of cis-chlordane, trans-chlordane and oxychlordane 0.05
3. 滴滴涕 DDT Sum of p,p’-DDT, o,p’-DDT, p,p’-DDE and p,p’-TDE 1.0
4. 異狄氏劑 Endrin endrin 0.05
5. 七氯 Heptachlor Sum of heptachlor and heptachlor epoxide 0.05
6. 六氯苯 Hexachlorobenzene hexachlorobenzene 0.1
7. 六六六 Hexachlorocyclohexane Sum of α-, β- and δ-isomers 0.3
8. 林丹 Lindane lindane 0.6
9. 五氯硝基苯 Quintozene Sum of quintozene, pentachloroaniline and methyl pentachlorophenyl sulphide 1.0

Table 2:Test parameters for organophosphate pesticides*
(*No organophosphate pesticide residues are allowed in Chinese herbal medicines)

1 Dichlorvos 滴滴畏
2 Methamidophos 甲胺磷
3 Trichlorphon 滴百蟲
4 Omethoate 氧樂果
5 Diazinon 二嗪磷
6 Dimethoate 樂果
7 Malathion 馬拉硫磷
8 Isocarbophos 水胺硫磷
9 Triazophos 三唑磷
10 Parathion對硫磷
11 Parathion-methyl 甲基對硫磷
12 Monocrotophos 久效磷
13 Phosphamidon 磷胺
14 Chlorpyriphos 毒死蜱
15 Acephate 乙酰甲胺磷
16 Ethion 乙硫磷
17 Methidathion 殺撲磷

Note: The consumption of Chinese herbal medicines with pesticide residues exceeding the maximum residue limits does not automatically imply a hazard to health provided that the intake of pesticides falls within the safety reference value for acceptable human daily intake.

Q :
What are the limits of heavy metals and toxic elements in Chinese herbal medicines?
A :
  • Under the market surveillance system, the Department of Health will draw samples of Chinese herbal medicines from the market on a regular basis for testing for heavy metals and toxic elements. The testing is undertaken by the Government Laboratory (GL). The GL will first conduct primary testing on the samples of Chinese herbal medicines. If excessive heavy metals and toxic elements are detected in the samples, second-stage testing, i.e. testing for heavy metals and toxic elements in the decoctions of the Chinese herbal medicine samples concerned, will be carried out so as to simulate the circumstances of human consumption.
  • The current limits of heavy metals and toxic elements in Chinese herbal medicines set by the Chinese Medicine Council of Hong Kong (CMC) are in terms of the maximum intake per day or per dose. Chinese herbal medicines which do not originate from mineral substances containing heavy metals or toxic elements as ingredients must not exceed the maximum limits shown in the table below (see Table 1).

Table 1: Limits of heavy metals and toxic elements in Chinese herbal medicines set by CMC

Chinese name English name Maximum limit (intake)
Arsenic 1 500 mcg/day
Cadmium 3 500 mcg/dose
Lead 179 mcg/day
Mercury 36 mcg/day