Singapore legislation

Regulation 24

of Health Products (Oral Dental Gums) Regulations 2016

Regulation 24

Changes affecting licence

Amended byS 457/2022 wef 01/07/2022

Subregulation 1

Subject to paragraph (2), a licensee must obtain the approval of the Authority for any change or proposed change to any particulars furnished by the licensee to the Authority in relation to the application for the licensee’s licence.

Subregulation 2

A licensee must obtain the prior approval of the Authority before making any change that significantly affects the activities of the licensee that are authorised by that licence.

Subregulation 3

Amended byS 457/2022 wef 01/07/2022

An application for the Authority’s approval under paragraph (1) or (2) must —

(a)

be made in the form and manner specified on the Authority’s website;

(b)

be submitted within such time as the Authority may specify in the conditions of the licence; (c)be accompanied by such particulars, information, documents or samples as the Authority may require; (d)be accompanied by the relevant fee specified in the Fees Regulations; and

(e)

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

Subregulation 4

For the purposes of paragraph (2), a change that significantly affects the activities of a licensee that are authorised by the licensee’s licence includes (but is not limited to) a change of one or more of the following:

(a)

the premises where the licensee operates;

(b)

the facilities and equipment used by the licensee;

(c)

the operations and processes carried out by the licensee.

Subregulation 5

A licensee who fails to comply with paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

Subregulation 6

A licensee who —

(a)

fails to comply with paragraph (2); or

(b)

in compliance or purported compliance with paragraph (3), furnishes the Authority with any information which the licensee knows is false or 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.