Government Legislation

Faculty are advised that all experiments involving the use of living vertebrate animals in Hong Kong must fulfil the requirements of all relevant legislation (refer to Appendix A) and should comply with relevant Codes of Practice including, but not limited to, the following:

  1. Animals (Control of Experiments) Ordinance (Cap. 340)

PDF version of Cap 340

1.1. The performance of experiments on living vertebrate animals in Hong Kong is subject to the provisions of the Cap. 340 Animals (Control of Experiments) Ordinance and Regulations.   Students, Technicians and Professional Staff cannot perform experiments on laboratory animals under the umbrella of a Faculty.

This means that all individuals directly involved in using animals for experiments whether Faculty, Professional Staff, Technical Staff or Post-Graduate Students (or Under-Graduate Students conducting ‘summer research projects’) must have their own individual licence.

Faculty and others working only with animal tissue after the animal has been euthanized and NOTHING was done to the living animal/s before it was killed, in the way of an experimental protocol, do not need to get a Department of Health (DoH) licence, as the act of euthanasia is not considered an experiment.

1.2. Please apply for a licence using Form 1 from the DoH if you want to carry out experiments on living vertebrates.    Additional authorization is required for:

(i) experiments to attain manual skill (endorsement);

(ii) experiments to illustrate lectures (teaching permit) and

(iii) experiments not performed under anaesthesia and recovery experiments (endorsement).

In this Ordinance, experiment means any experiment performed on an animal and calculated to give pain.   The DoH has advised that the following information should be provided in the application:

(i) how the experiments advance scientific knowledge and benefit mankind and/or animals, and

(ii) measures to minimise the suffering of animals.

1.3. For teaching practical classes, students involved in a practical class that use animals in ‘experiments’ as part of the teaching curriculum, will be covered by a DoH issued ‘bloc licence’ which covers a group of named students who perform experiments(s) under the supervision of a licensed staff with the relevant teaching permit.   A new licence is required if there is a change in the type of animals to be used or a change in the experimental procedures to be performed on the animals.

1.4. The application form  for  Cap.  340  licence/permit/endorsement  and  guidelines  for  applications  can  be downloaded from the website of the DoH

1.5. DH’s contact details are as follows:

Address: Special Health Services
Department of Health
21/F, Wu Chung House
213 Queen’s Road East, Wan Chai, Hong Kong
Tel: 2961 8975
Fax: 2127 7329
E-mail: ro_al@dh.gov.hk

1.6. Applicants are advised to read the Guide to the application for a licence under the Animals (Control of Experiments) Ordinance before filling in the form. Sample application forms are available for reference. Applicants are also advised to read the presentation of the briefing sessions on Application for Licence under the Animals (Control of Experiments) Ordinance, Cap. 340 held on 18 and 30 October 2013.

1.7. The Animals (Control of Experiments) Regulations stipulate that every licensee shall keep records of all licensed experiments performed by him/her in the form set out in Form 6 and shall render to the DoH on or before the 1st day of January of each year a return in the form set out as Form 7 of all licensed experiments performed by him/her during the preceding twelve months. With effect from 1 November 2013, an Annexe has been added to Form 7 to facilitate processing of the returns

1.8. The licensee in completing “Form 7 – Return of Experiments” must list all experiments performed and include the required information such as the kinds and number of animals used, (i.e. those animals which have been euthanised after completion of the experiments) during the preceding twelve months. Please note that “Nil Return” is required by the DoH i.e. a ‘Nil Return’ means that no experiment has been performed under that licence number by the licensee during the period. For non-faculty licensees they are required to complete a “Form 7 – Return of Experiments” but need only indicate that their Form 7 relates to their supervising Faculty member’s licence.

1.9. The APCF can assist, if requested by Faculty, by providing an annual report in mid-December each year to individual researchers/ teachers listing the number of animals supplied by the APCF during the year to facilitate their submission of annual returns to the DoH.   DoH officials may enter/inspect premises where licensed experiments are performed and carry out an on-site inspection of “Form 6” records of licences with/without prior notice.

1.10. Licensees are advised to read the explanatory notes before filling in the Form 7Sample return forms are available for reference.

  1. Prevention of Cruelty to Animals Ordinance (Cap. 169)

PDF version of Cap 169

2.1. The purpose of this Ordinance is to prohibit and punish cruelty (viz unnecessary suffering) to animals.

2.2. Unnecessary suffering includes any form of ill-treatment of animals (for example: kicking or terrifying the animals; failure to supply the animals with sufficient food and fresh water; failure to convey the animals in suitable containers; use of animals that are diseased or injured, such that they should not be used for such purposes and keeping; or allowing to be kept under one’s control, any animal in any way which may cause it needless or avoidable suffering).

2.3. Faculty is reminded that the licence issued under Cap. 340 [Animals (Control of Experiments) Ordinance and Regulations] provides a defence to the researcher from prosecution under Cap 169 [the Prevention to Cruelty to Animals Ordinance] only if the licence holder complies fully with the approved AEC protocol and the consequential terms of the licence as issued by the Department of Health.

  1. Dangerous Drugs Ordinance (Cap. 134)

PDF version of Cap 134

3.1. A person in charge of a laboratory used for the purposes of research and attached to a university is authorized under the Dangerous Drugs Ordinance to be in possession and to supply dangerous drugs (e.g. ketamine, midazolam, fentanyl citrate).   Dangerous drugs can be obtained from the APCF, subject to the DoH Licence conditions and the AEC approved protocols only.

3.2. Researchers and the aforesaid persons using dangerous/scheduled drugs are required to comply with the storage and record keeping provisions of the Dangerous Drugs Ordinance as follows:

(i). Storage:

Dangerous drugs should be kept in a locked receptacle which can only be opened by the person authorized under the Dangerous Drugs Ordinance to possess them.

(ii).Record-keeping:

(a) The authorized person in possession of dangerous drugs must keep a “Dangerous Drugs Register” in which all transactions of dangerous drugs must be recorded. The format of this Register is fixed by the Ordinance.

(b) A separate Dangerous Drugs Register, or a different page of the same Register, should be used for each dangerous drug.    The name of the dangerous drug preparation and (where applicable) the strength or concentration of the preparation should be written at the head of each page of the Register.

(c) Every receipt or supply of a dangerous drug must be recorded, in indelible ink, on the day of the transaction or, if this is not practicable, on the following day.    No cancellation or alteration of any record is permitted.   Corrections must be made by means of a marginal note or footnote and must be dated.

(d) All used registers must be kept in the laboratory for two years from the date on which the last entry was made.   It is advisable that all supporting documents such as invoices should also be kept for two years.

  1. Other related government legislation and Codes of Practice in Hong Kong

4.1. Antibiotics Ordinance, Cap 137

PDF version of Cap 137

4.2. Pharmacy and Poisons Ordinance, Cap 138

PDF version of Cap 138

(i). Under Regulation 36B (the regulation) of the Pharmacy and Poisons Regulations, a “Certificate for Clinical Trial/Medicinal Test” (the certificate) is required for the purpose of conducting a ‘clinical trial on human beings’ or a ‘medicinal test on animals’.   The regulation only applies to pharmaceutical products.

(ii). “Pharmaceutical product” means any substance or combination of substances –

(a). presented as having properties for treating or preventing disease in human beings or animals, or

(b). that may be used in, or administered to, human beings or animals, either with a view to –

(i). restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; or

(ii). making a medical diagnosis.

(iii). If you have an animal experiment which falls within the scope of the aforesaid regulation, you should apply for a “Certificate for Clinical Trial/Medicinal Test” from the DoH.   For details, please refer to the information posted on the DoH website.

4.3. Public Health (Animals and Birds) Ordinance, Cap 139

PDF version of Cap 139

4.4. Wild Animal Protection Ordinance, Cap 170

PDF version of Cap 170

4.5. Radiation Ordinance, Cap 303

PDF version of Cap 303

4.6. Waste disposal subject to the conditions of Cap 354 Sect 33: Waste Disposal (Chemical Waste) (General) Regulation

PDF version of Cap 354

4.7. Rabies Ordinance, Cap 421

PDF version of Cap 421

4.8. Occupational Safety and Health Ordinance, Cap 509

PDF version of Cap 509

4.9. the Protection of Endangered Species of Animals and Plants Ordinance (Cap 586)

PDF version of Cap 586

4.10. Genetically Modified Organisms (Control of Release) Ordinance, and Regulations and Exemptions [Cap. 607 and 607A and 607B]. For HKUST the scope of the Ordinance is limited to not releasing transgenic plants or animals to the environment.

PDF version Cap 607

4.11. Rodent and Other Pest Control requirements

4.12. Code of Practice for Care and Use of Animals for Experimental Purposes (2004)  published by Animal Welfare Advisory Group, (AWAG) can be downloaded from Agriculture, Fisheries and Conservation Department’s (AFCD) Animal Management web-site

To assist Faculty with their compliance with Hong Kong laws, their understanding and forbearance is requested as, the APCF and AEC will require copies of DoH licences with all AEC applications, requests for cage holding space, requests for animal care and Faculty may also be asked for the DoH licence from time to time as part of the APCF’s and AEC’s VPRGO-approved Post-Approval Monitoring (PAM) programme to ensure all individuals conducting experiments at HKUST are in full compliance with relevant Hong Kong laws.

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