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 responsible for implementing 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 as well as registration of proprietary Chinese medicines.

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 Medicine Regulatory Office, Department of Health at 3904 9227 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.

Q :

Can one send proprietary Chinese medicines and Chinese herbal medicines to and from Hong Kong by post?

A :

According to the Import and Export Ordinance (Cap 60, Laws of Hong Kong), the import and export, through different modes of transport, including postage, of proprietary Chinese medicines and 36 types Chinese herbal medicines (including 31 Chinese herbal medicines specified in Schedule 1 and the 5 Chinese herbal medicines specified in Schedule 2 (Flos Campsis (凌 霄 花);processed Radix Aconiti (製 川 烏);processed Radix Aconiti Kusnezoffii (製 草 烏);Radix Clematidis (威 靈 仙)and Radix Gentianae (龍 膽) of the Chinese Medicine Ordinance) as listed in the Schedule 1 and 2 to the Import and Export (General) Regulations (Chapter 60, sub Leg.A), Laws of Hong Kong, are subject to licensing control. Importation / Exportation of these articles must be covered by an import/ export licence issued by the Chinese Medicine Regulatory Office of the Department of Health. The Chinese Medicine Regulatory Office will only accept application of Import or Export Licences from licensed Chinese medicines traders.

Q :

When planning to return exported pCm to Hong Kong, what should the Chinese medicines trader consider?

A :

The application for return of goods should be made in writing by the licensed trader (applicant company) who originally applied for export licences of the said pCm. The applicant company should also provide the following information:

  1. Copies of the export licences related to the export of the pCm,
  2. The actual departure date of the pCm,
  3. The reasons for return of the pCm as provided by the consignee company (as listed on the export licence) or by the local regulatory authority,
  4. the quantity, batch number and expiry date of pCm to be returned (the batch number and expiry date could be provided subsequently after the goods arrived at Hong Kong),
  5. the purpose of importing the pCm:
    1. If the pCm are for disposal:
      1. The applicant company has to produce a copy of Registration of Waste Producer issued according to Waste Disposal(Chemical Waste)(General) Regulations, Cap 354C, Laws of Hong Kong,
      2. After the pCm returned to Hong Kong, the applicant company should immediately appoint a chemical waste collector licensed by the Environmental Protection Department to collect the pCm (chemical waste). After the collection of the chemical waste, the copy of the trip ticket should be sent to CMRO.
    2. If the pCm is for resale or re-supply:
      1. There should be evidence to show that the pCm has been stored in suitable storage condition after it left Hong Kong, to ensure that the pCm has not been contaminated or its quality affected,
      2. If the pCm is a registered pCm in Hong Kong, the applicant company should produce an authorization letter from the holder of Registration Certificate of pCm or Notice of confirmation of transitional registration of pCm(holder) authorizing the applicant company to import the pCm and the holder undertaking to examine the returned pCm, and release the pCm for sale or supply after it passed the examination*,
      3. If the pCm is not a registered pCm in Hong Kong, the applicant company should produce a written declaration undertaking that it will entrust a local recognized laboratory to examine the sample of the pCm in accordance to the product specification and sampling instruction provided by the overseas pCm manufacturer or send the sample of the pCm back to its overseas manufacturer for examination; or
        the applicant company should produce a written declaration from the overseas pCm manufacturer who undertakes that it is willing to accept the whole batch of pCm, examine the pCm according to its product specification and will only release the pCm after passing the examination.

        *the examinations should be based on the particulars/application information of the pCm.

CMRO may request for additional documents should the need arises.

When evaluating an application for return of pCm, CMRO would conduct assessment on the potential risk to public health, based on the information provided by the applicant company; and used the assessment as the basis of the evaluation.

Once CMRO considers that he documents are in order, it will process the application of import licence of pCm (returned goods).

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 Regulatory Office
Department of Health
16/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon

Enquiry Hotline : 2319 5119
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 it 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 (plant-based)?
A :
  • Under the market surveillance system, the Department of Health will draw samples of 542 Scheduled Chinese herbal medicines (plant-based)note 1 under the Chinese Medicine Ordinance (the Ordinance) from the market on a regular basis for testing for pesticide residues. The “List of plant-based Chinese herbal medicines specified in the Schedules of the Chinese Medicine Ordinance” can be downloaded here.
  • Due to the different regulatory requirements on pesticide residues of Chinese herbal medicines in various places, licensed traders should ensure the imported Chinese herbal medicines comply with the requirements and standards set by the CMCHK.
  • The testing of samples is undertaken by the Government Laboratory (GL). The GL will conduct testing for pesticide residues in the decoctionsnote 2 of the Chinese herbal medicine samples concerned, so as to simulate the circumstances of human consumption.
  • The pesticide residues detected in the decoctions must not exceed the maximum residue limits of organochlorine pesticides concernednote 3 (see Table 1). In general, no organophosphate pesticide residues are allowed in the decoctions (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 1: From 31 December 2021 onwards, the CMCHK repeals limits of pesticide residues for animal-based and mineral-based Chinese herbal medicines in the Schedules of the Ordinance.

Note 2: In general, the method of decoction is as follows:

  1. Weigh accurately 20 g of Chinese herbal medicine sample.
  2. Add 200 mL of water.
  3. Heat up the mixture to boiling using maximum temperature setting then adjust to medium temperature setting to boil for 20 minutes. Add boiling water if necessary to avoid drying up of decoction.
  4. Filter while hot and collect the liquid content (Fraction A), and let it cool down to room temperature. To the residue, add 150 mL of water and boil for another 20 minutes with medium temperature setting. Add boiling water if necessary to avoid drying up the decoction.
  5. Filter while hot and collect the liquid content (Fraction B), and let it cool down to room temperature.
  6. Mix Fraction A and Fraction B (total volume should not exceed 200 mL), and add water to make up 200 mL of decocted sample.
  7. Pipette 20 mL or appropriate amount of decocted sample to conduct the pesticide residues determination.

Note 3: 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 of samples is undertaken by the Government Laboratory (GL). The GL will conduct testing for heavy metals and toxic elements in the decoctionsnote of the Chinese herbal medicine samples concerned, 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

Note: In general, the method of decoction is as follows:

  1. Weigh accurately 20 g of Chinese herbal medicine sample.
  2. Add 200 mL of water.
  3. Heat up the mixture to boiling using maximum temperature setting then adjust to medium temperature setting to boil for 20 minutes. Add boiling water if necessary to avoid drying up of decoction.
  4. Filter while hot and collect the liquid content (Fraction A), and let it cool down to room temperature. To the residue, add 150 mL of water and boil for another 20 minutes with medium temperature setting. Add boiling water if necessary to avoid drying up the decoction.
  5. Filter while hot and collect the liquid content (Fraction B), and let it cool down to room temperature.
  6. Mix Fraction A and Fraction B (total volume should not exceed 200 mL), and add water to make up 200 mL of decocted sample.
  7. Pipette 20 mL or appropriate amount of decocted sample to conduct the heavy metals and toxic elements determination.
Q :
What are the limits of sulphur dioxide residue in Chinese herbal medicines?
A :
  • Referring to the limits of sulphur dioxide residue published in the Pharmacopoeia of the People’s Republic of China (2015 edition) (CP2015) and the Hong Kong Chinese Materia Medica Standards (HKCMMS), the CMCHK has set the limits of sulphur dioxide residue in Chinese herbal medicines as specified in Schedules 1 and 2 and their decoction pieces.
  • From 1 June 2022 onwards, the Department of Health has also incorporated sulphur dioxide residue as a testing parameter into market surveillance programme of Chinese herbal medicines.
  • Testing methods for determination of sulphur dioxide residue
    Please refer to the “acid-base titration” method stated in CP2015, which has been adopted by the HKCMMS, or other testing methods stated in CP2015 (i.e. "gas chromatography" or "ion chromatography") for the determination of sulphur dioxide residue in Chinese herbal medicines and their decoction pieces.
  • Please see the table below for the limits of sulphur dioxide residue in Chinese herbal medicines set by the CMCHK:
Name of Chinese herbal medicine Limits of sulphur dioxide residue
All Chinese herbal medicines (except for those otherwise specified and minerals) not more than 150 mg/kg
1. Radix Asparagi not more than 400 mg/kg
2. Radix Trichosanthis
3. Rhizoma Gastrodiae
4. Radix Achyranthis Bidentatae
5. Rhizoma Bletillae
6. Rhizoma Atractylodis Macrocephalae
7. Radix Paeoniae Alba
8. Radix Codonopsis
9. Radix Puerariae For root of Pueraria thomsonii Benth (that is Puerariae Thomsonii Radix in CP2015), not more than 400 mg/kg
For root of Pueraria lobata (Willd.) Ohwi (that is Puerariae Lobatae Radix in CP2015), not more than 150 mg/kg