Useful Information

Application for Animal Experiment Licence

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

The This link will open in a new windowAnimals (Control of Experiments) Ordinance (Cap. 340) (the Ordinance) provides for the control of experiments on living vertebrate animals. Under the Ordinance, "animal" means a living vertebrate animal and "experiment" means any experiment performed on an animal and calculated to give pain to the animal. Before performing an animal experiment, a person shall apply for a licence for that particular experiment. Please refer to the sections below for details.

Type of Licences

There are different types of licence, permit and endorsements for experiments of different nature which include:

• Licence to Conduct Experiment (Form 2);
• Endorsement to Authorize Experiments to Attain Manual Skills (Form 3);
• Teaching Permit (Form 4); and
• Endorsement to Authorize Experiments without Anaesthetics or without Destroying the Animal (Form 5).

Application Procedures

To apply for licence/ permit/ endorsement(s), an applicant should submit the completed application form (Form 1) and Annex to Form 1 to the Director of Health. Applicant is encouraged to submit Form 1 online. The online form requires digital signature by either digital certificate or “iAM Smart+ ”.

Alternatively, you may submit Form 1 by email or post:

Address:	Health Technology and Advisory Division Department of Health 21/F, Wu Chung House 213 Queen's Road East, Wan Chai, Hong Kong
E-mail:	ro_al@dh.gov.hk

Requirement for renewal of licence

If an applicant wishes to continue the same animal experiment without changes to procedures or purposes as stated in the previously granted licence, they shall indicate this in the Annex to Form 1 and quote the previous licence reference number as appropriate. Any changes, including but not limited to animal types, procedures, purposes or euthanasia methods, require a new application. It will be a breach of the Ordinance to conduct experiments not in accordance with the terms of the licence or beyond the expiry date of licence.

Requirement for variation of licence

If there are changes of places for conducting animal experiment, prior approval should be sought by informing the Department of Health (“DH”) in writing. No animal experiment should be conducted at the new location(s) until formal approval has been received from DH. Any other changes require a new application. It will be a breach of the Ordinance to conduct experiments at places not specified in the licence.

Useful information

For applicants
Applicants are advised to read the following documents before filling in the forms

• This link will open in a new windowGuide to application for licence under the Animals (Control of Experiments) Ordinance
• This link will open in a new windowExplanatory Notes and Samples of Completed Forms (Form 1, Form 6 and Form 7)

For licensees and supporting personnel
Two identical briefing sessions were held on 6 and 11 November 2024 with the aim to clarify the requirements of the Ordinance and the risk-based approach for inspection, highlight crucial compliance issues for parties concerned and common pitfalls to avoid.

• This link will open in a new windowPresentation file of the webinar

Important notes to licensees

1. Keeping Records

   The This link will open in a new windowAnimals (Control of Experiments) Regulations (Cap. 340A) (the Regulations) stipulate that every licensee shall keep records of all licensed experiments performed by him/her in the form set out as Form 6. Licensees shall permit authorized officer to enter and inspect the places where experiments may be conducted for the purpose of securing compliance with the provisions of the Ordinance. Failure to comply with the above legal duty is an offence. Licensees are advised to read the Explanatory Notes and Samples of Completed Forms for completion of Form 6.

2. Rendering Returns

   The This link will open in a new windowRegulations stipulate that every licensee shall render to the Director of Health 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. Failure to comply with the above legal duty is an offence. Form 7 and its Annex can also be filled out electronically and submitted online. Licensees are advised to read the Explanatory Notes and Samples of Completed Forms for completion of Form 7.

3. Performing experiment in accordance with the terms of the licence

   Section 3(2) of the Ordinance stipulates that no licensee shall perform any experiment except in accordance with the terms of his licence and subject to the restrictions imposed by the Ordinance. If you wish to perform experiments other than the one described in your existing licence or if there are any changes of the experiments, including but not limited to the type(s) of animals used, experimental procedure(s), and method(s) used to sacrifice the animals, you have to submit a new application to perform the experiments. It will be a breach of the Ordinance to conduct experiments not in accordance with the terms of the licence.

Annual Enforcement statistics

Law Enforcement	2024
Recorded verbal warning	3
Written warning	15

Enquiries

For enquiries, please contact us at:

Tel:	2961 8975
Fax:	2127 7329
E-mail:	ro_al@dh.gov.hk