Useful Information
Determination of Application for Exemption
An applicant will be given a written notice of the decision of the application by registered post. The Director of Health ("the Director") may decide to approve the application and grant the exemption, or reject the application. If the application is rejected, a statement stating out the reasons for such decision will be included in the notice.
In approving the application for exemption, the Director may specify the extent of the Human Organ Transplant Ordinance (Cap. 465) ("the Ordinance") which shall not be applicable to a regulated product. The Director may also (a) limit the validity of the exemption to a specified period; or (b) grant the exemption only to the applicant, a specified person or a specified class of persons. Moreover, the Director may grant the exemption subject to such conditions as the Director considers appropriate, including a condition limiting the exemption only for a particular occasion or for the purpose of a specified type of transplant.
Extent of Exemption
The Director may decide to exempt the regulated product from the application of all parts or part(s) of the Ordinance. Sections 4-7 of the Ordinance are particularly relevant and the applicants are advised to refer to these provisions for details.
Exemption Conditions
The Director may impose conditions on the exemption granted. On the breach of the condition(s) imposed, the Director may revoke, vary or suspend the exemption concerned.
Validity Period of Exemption
The validity period of an exemption depends on the validity period of marketing approval obtained in overseas countries, which will be up to 5 years. The applicant shall submit another application at least 3 months before the expiry of the exemption if the applicant wishes the regulated product to continue to be exempted.
Register of Exemptions
Details of the exemptions granted will be included in the Register of Exemptions. The Register of Exemptions is also available for inspection by the public, free of charge, at the following office of the Department of Health.
| Address: |
Health Technology and Advisory Division Department of Health 21/F, Wu Chung House 213 Queen's Road East, Wanchai, Hong Kong (Re: Exemption of regulated products) |
|
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. |
| Tel: | (852) 2961 8944 |
| Fax: | (852) 2127 7329 |
| Email: | hot_rpe@dh.gov.hk |
Appeal
If a person is aggrieved by a decision of the Director in relation to the exemption, he/she may appeal to the Appeal Board established under the Human Organ Transplant (Appeal Board) Regulation (Cap. 465B). For details, please refer to the section" Appeal against a decision of the Director in relation to the exemption".