Singapore legislation

Section 35

of Health Products Act 2007

Section 35

Re‑categorisation or re‑classification of health products on application of registrant

(1)

The Authority may, upon the application of the registrant of a registered health product —

(a)

transfer the health product from the category or class under which it has been registered to another category or class; and

(b)

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.

(2)

An application under subsection (1) for the re‑categorisation or re‑classification of a registered health product must —

(a)

be made to the Authority in such form and manner as the Authority may require; and

(b)

be accompanied by —

(i)

such particulars, information, documents and samples as the Authority may require; and

(ii)

if required by the Authority, a statutory declaration by the applicant verifying any information contained in or relating to the application.

(3)

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.

(4)

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.

(5)

Any person who, in making an application under subsection (1) for the re‑categorisation or re‑classification of a registered health product —

(a)

makes any statement or furnishes any document which the person knows to be false or does not believe to be true; or

(b)

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.

Read in full context — Health Products Act 2007 →