Health Products Act 2007 · 2020 Revised Edition · Part 7 · Registration of Health Products
36. Power to re‑categorise or re‑classify health products in absence of application by registrant
Feedback & supportWhere —
the Authority is satisfied upon information received by it in respect of a registered health product that the health product should be transferred from the category or class under which it has been registered to another category or class; but(b)the registrant of the health product has not made an application under section 35 for the health product to be so re‑categorised or re‑classified,the Authority may, subject to subsection (2), of its own volition re‑categorise or re‑classify the health product 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.
Before re‑categorising or re‑classifying a registered health product under subsection (1), the Authority must —
registered health product
“registered health product” means a health product currently registered under Part 7;
give to the registrant of the health product written notice of its intention to do so; and
in the notice, call upon the registrant, if the registrant wishes, to show cause within the time specified in the notice as to why the health product should not be re‑categorised or re‑classified as intended by the Authority.
If the registrant of the health product —
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;
is agreeable to the re‑categorisation or re‑classification of the health product; or
fails to show cause within the period of time given or such extended period of time as the Authority may allow, or fails to show sufficient cause as to why the health product should not be re‑categorised or re‑classified as intended by the Authority,the Authority must give written notice to the registrant of the health product of the date from which the re‑categorisation or re‑classification of the health product is to take effect.
The Authority may also in the notice given under subsection (3) require the registrant of the health product to 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.
The registrant of a health product who fails to comply with any of the requirements attached under subsection (4) to a notice given to the registrant under subsection (3) 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.
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;
Where the registrant of a health product does not wish to have the health product re‑categorised or re‑classified as intended by the Authority under this section, the registrant may apply to the Authority to cancel the registration of the health product.