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Useful Information

How to Apply?

Applicant

According to section 7B(1) of the Human Organ Transplant Ordinance (Cap. 465) ("the Ordinance"), a person may apply for an exemption in respect of a regulated product by submitting an application to the Director of Health ("the Director").

If the applicant is not the manufacturer of the regulated product under application, a documentary proof from the manufacturer to authorise the applicant to apply for an exemption is required.

Guidance Notes on Application for Exemption of Regulated Products

Detailed information on the legal requirements, application procedures and documents for exemption of regulated products under the Ordinance are set out in the Guidance Notes. A person who wishes to apply for an exemption in respect of a regulated product is recommended to read and follow the instructions in the Guidance Notes.

Application Form

Application for exemption should be made on the standard application form. The applicant should fill in all items of information requested in the form, and provide supporting documents as specified in the application form.

Submission of Application

Duly completed application form and the required supporting documents should be submitted by post, or by hand during office hours to the Department of Health ("the DH") at the following address:

Address:

Special Health Services
Department of Health
21/F, Wu Chung House
213 Queen's Road East, Wanchai, Hong Kong

Office hours-
Mondays to Fridays
(except public holidays):

9:00 a.m. to 1:00 p.m.; and 2:00 p.m. to 5:30 p.m.

Acknowledgement of Receipt

An acknowledgement will be issued to the applicant upon receipt of the application form and the required supporting documents. If the applicant does not receive the acknowledgement within 2 weeks after submission, he/she may contact us to check whether the submission has reached our office.

Tel:

(852) 2961 8645

Fax:

(852) 2127 7329

Email:

hot_rpe@dh.gov.hk

Offence

According to section 7B(7) of the Ordinance, any person who, in submission of application for exemption of regulated product, provides information that he/she knows to be false or misleading in a material respect, or recklessly provides information that is false or misleading in a material respect, commits an offence and is liable on conviction to a fine at level 5 and to imprisonment for 3 months.



Last Revision Date : 28 June 2016