Useful Information

Q.1

What is a regulated product?

A.1

According to section 7A of the Human Organ Transplant Ordinance (Cap. 465),

1. "regulated product" means a product containing any structured arrangement of tissues that –
   1. falls within paragraph (a) (iii) of the definition of "organ" in section 2 of the Ordinance; and
   2. has been subjected to processing;
2. "processing", in relation to any structured arrangement of tissues, means any activity performed on the tissues which alters the biological characteristics, function or integrity of the tissues, but does not include recovering or preparing the tissues, preserving the tissues for storage, or removing the tissues from storage.

Q.2

What is the definition of "organ" in the Human Organ Transplant Ordinance (Cap. 465)?

A.2

Under section 2 of the Ordinance, “organ”

1. means, except in relation to sections 5 to 7 of the Ordinance-
   1. any human bodily part which-
      1. consists of a structured arrangement of tissues; and
      2. if wholly removed, cannot be regenerated by the body;
   2. any human bodily part specified in the Schedule, that is blood (including cord blood) and bone marrow; or
   3. any structured arrangement of tissues forming part of any human bodily part mentioned in subparagraph (i) or (ii);
2. means, in relation to sections 5 to 7 of the Ordinance-
   1. any human bodily part mentioned in paragraph (a)(i) and not specified in the Schedule; or
   2. any structured arrangement of tissues forming part of any human bodily part mentioned in subparagraph (i).

Q.3

What are examples of regulated products?

A.3

Skin and bone derived products are some examples of regulated products. The scope of regulated products does not cover autologous therapeutic products.

Q.4

What are the reasons for introducing a mechanism for exempting the regulated products under the Human Organ Transplant Ordinance (Cap. 465)?

A.4

With the advances in medical technology, certain products made from human tissues (such as skin and bone derived products) are now available overseas for transplanting purposes. As these products fall within the definition of "organ" in section 2 of the Ordinance, commercial dealings of these products are prohibited in Hong Kong. To allow registered medical practitioners and registered dentists in Hong Kong the opportunity to use these products for transplant without contravening the Ordinance, amendment has been made to the Ordinance to provide for the Director of Health ("the Director") a mechanism to exempt these products (namely "regulated products") from the provision of commercial dealings and other sections of the Ordinance as appropriate. However, the principles enshrined in the Ordinance that donation of human organs/tissues for making of these products is on a voluntary basis are upheld. A product which falls within the definition of "organ" and has been subjected to "processing" as stipulated in the Ordinance will be regarded as "regulated product". The Director may, on application, exempt a regulated product from the application of the whole or any part(s) of the Ordinance. The amended Ordinance has come into operation on 1 September 2011.

Q.5

How can the public know whether a regulated product has already been exempted?

A.5

According to section 7E of the Human Organ Transplant Ordinance (Cap. 465), the Director of Health shall maintain a register containing details of the exemptions granted, revoked, varied or suspended under the Ordinance. Details of the exemptions will be included in theRegister 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.

Q.6

Who should apply for exemption of a regulated product?

A.6

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

Q.7

How to apply for exemption of a regulated product?

A.7

You can fill out and submit the application online. The online form requires digital signature by either digital certificate or “iAM Smart”.

For submission by post or by hand, the applicant should print and sign on the PDF application form with company chop (if applicable). Duly completed PDF application form and the required supporting documents should be submitted during office hours to the Department of Health at the following address:

Q.8

In applying for an exemption of a regulated product, what are the documents required?

A.8

You should read the Human Organ Transplant Ordinance (Cap. 465) and its subsidiary regulations and the Guidance Notes on exemption of regulated products under the Human Organ Transplant Ordinance before completing the application form.

The documents required are as follows, which you can also find in the Guidance Notes and Application Form:

• A completed Application Form
• A copy of the HKID card or passport of the applicant
• A copy of the business registration certificate of the applicant (if applicable)
• An authorisation letter from the applying company designating a representative (“authorised representative”) to make the application and handle related matters on behalf of the company
• A letter from the manufacturer to authorise the applicant to apply for an exemption unless the applicant is the manufacturer of the product
• A documentary proof of marketing approval (e.g. free sale certificate) by the regulatory authority in the United States, European Union, Canada or Australia or a country with equivalent product assessment standards
• A documentary proof of compliance with Good Tissue Practice (GTP), Good Manufacturing Practice (GMP) or equivalent standard for each of the facilities involved in tissue procurement, tissue processing and/or product manufacturing steps
• A documentary proof from the manufacturer certifying that in accordance with section 7A(3)(b) to (d) of the Human Organ Transplant Ordinance (Cap. 465), in obtaining tissues from donors and in processing the tissues for the purpose of producing regulated products to be supplied in Hong Kong:
  • the donor of the tissues concerned has given his consent to the removal of the tissues for the purpose of producing the product without coercion or the offer of inducement, or that the tissues are removed for the therapy of the donor;
  • no payment has been made, or is intended to be made to that donor for his supplying the tissues from his body; and
  • all applicable laws of the place where the tissues were obtained or processed have been complied with in obtaining and processing the tissues
• Product assessment reports issued by overseas regulatory authorities (if available)
• A technical dossier to provide the following information:

• Organ/tissue donation:

• The policy of the manufacturer and the laws of the place/country where human organ/tissue is procured governing obtaining consent and payment to donation

• Donor screening and testing:

• Criteria for selection or exclusion of donors including a list of examinations and laboratory tests required for donor evaluation

• Evaluation of product safety, quality and efficacy:

• Overview of the product development
• Overview of the manufacturing processes and controls, and other quality aspects relating to the manufacturing of the product
• Summary of non-clinical and clinical studies substantiating the safety and, if applicable, efficacy of the product
• Photographs of the regulated product (including the sales pack, inner container or package, and the tissue product itself) – labels on all sides of the packaging should be clearly shown in the photographs
• Labels and package inserts for use in Hong Kong – which should be the same as the ones approved by the overseas regulatory authority
• A sample of the outer package of the sales unit of the regulated product, or its drawing, with a designated space for displaying the exemption number (i.e. HK-RPEx No.: XXXXXX).
• Description of the track and trace systems of the manufacturer and the applicant that allow tracking of individual products from donors to end users or recipients, and tracing from end users or recipients to donors.

Q.9

What is the application fee for applying for the exemption of a regulated product?

A.9

Application for exemption is free of charge.

Q.10

How can I get more information about the exemption of regulated products?

A.10

Details of the exemption of regulated products ,such as application form, guidance notes, register of exemptions, are available at the Department of Health website (https://www.dh.gov.hk/english/useful/hot_exemption.html).

Q.11

What shall I do if I am not satisfied with the Director of Health's decision on the application for exemption of a regulated product?

A.11

If a person is aggrieved by a decision of the Director of Health in relation to the exemption, he/she may appeal to the Appeal Board by giving the secretary of the Appeal Board a notice of appeal. The notice of appeal must be given within 30 days after the date of the notice of the decision given by the Director. For details, please refer toAppeal against a Decision of the Director of Health in relation to the Exemption.

Q.12

What is the penalty if the applicant provides false information when applying for exemption in respect of a regulated product?

A.12

According to section 7B of the Human Organ Transplant Ordinance (Cap. 465), any person who, in purported compliance with the foregoing section, provides information that he 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.