Health Products Act 2007 · 2020 Revised Edition · Part 7 · Registration of Health Products
30. Registration of health products
Feedback & supportAn application for the registration of a health product must —
health product
“health product” means any substance, preparation or device —(a)that —(i)is represented for use by humans;(ii)whether because of its presentation or otherwise, is likely to be taken for use by humans; or(iii)is included in a class of substances, preparations or devices which are or are ordinarily intended for use by humans,solely or principally for a health-related purpose; and(b)that falls within any of the categories of health products specified in the First Schedule;
be made to the Authority by such person and in such form and manner as the Authority may require;
state the category (and, where applicable, the class within that category) under which the applicant is seeking to have the health product registered; and
be accompanied by —
such particulars, information, documents and samples as the Authority may require; and
if required by the Authority, a statutory declaration by the applicant verifying any information contained in or relating to the application.
Upon receiving an application under subsection (1), the Authority may —
register the health product if it is satisfied that —
the applicant is a fit and proper person to be granted the registration;
the registration of the health product will not be contrary to the public interest; and
the health product complies with such requirements as may be prescribed; or
refuse to register the health product.
The Authority may register a health product under the category and class stated in the application for its registration if the Authority is satisfied, after an evaluation of the health product under section 33, that the health product is suitable to be so registered.
If the Authority finds that a health product is not suitable for registration under the category or class stated in the application, it may —
recommend to the applicant that the health product be registered under a more suitable category or class as determined by the Authority; or
refuse to register the health product.
If the applicant accepts the recommendation of the Authority under subsection (4)(a), the Authority must, subject to the payment of the appropriate prescribed fee by the applicant, register the health product under the category or class recommended by it.
If the applicant does not wish to register the health product under the category or class recommended by the Authority under subsection (4)(a), the applicant may —
within such time as the Authority may allow, submit to the Authority such additional information, documents and samples as the Authority may require in support of the application to have the health product registered under the category or class stated in the application; or
withdraw the application.
Upon considering the additional information, documents and samples submitted by the applicant under subsection (6)(a), the Authority may do any of the following:
register the health product under the category and class stated in the application if it is satisfied that it is appropriate to do so;
subject to the payment of the appropriate prescribed fee by the applicant, register the health product under the category or class recommended by the Authority under subsection (4)(a) if the applicant is agreeable to it;
refuse to register the health product.
Upon registering a health product under this Act, the Authority must assign a registration number to the health product and must enter in the Register of Health Products the prescribed information pertaining to that health product.
Register of Health Products
“Register of Health Products” means the Register of Health Products kept and maintained by the Authority under section 34;
Where the Authority refuses to register a health product under subsection (2)(b), (4)(b) or (7)(c), the Authority must, if requested to do so by the applicant, state in writing the reasons for the refusal.
Any person who, in making an application for the registration of a health product —
makes any statement or furnishes any document which the person knows to be false or does not believe to be true; or
by the intentional suppression of any material fact, furnishes information which is misleading,shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.