Health Products Act 2007 · 2020 Revised Edition · Part 7 · Registration of Health Products
35. Re‑categorisation or re‑classification of health products on application of registrant
Feedback & supportThe Authority may, upon the application of the registrant of a registered health product —
transfer the health product from the category or class under which it has been registered to another category or class; and
cause such amendments to be made in the Register of Health Products as may be necessitated by the re‑categorisation or re‑classification of that health product.
An application under subsection (1) for the re‑categorisation or re‑classification of a registered health product must —
registered health product
“registered health product” means a health product currently registered under Part 7;
be made to the Authority in such form and manner as the Authority may require; 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 the re‑categorisation or re‑classification of a registered health product under this section, the registrant of the health product must take such steps as may be specified by the Authority to secure the necessary changes to the presentation and advertisement of the health product so as to bring them in conformity with the new category or class of the health product.
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;
If the registrant of the health product fails to comply with subsection (3), the registrant 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.
registrant
“registrant”, in relation to a registered health product, means the person who applied for and obtained the registration of the health product under this Act;
Any person who, in making an application under subsection (1) for the re‑categorisation or re‑classification of a registered 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.