Singapore legislation
Regulation 25
Regulation 25
Changes concerning registered oral dental gum
Subregulation 1
A registrant of an oral dental gum must obtain the prior approval of the Authority before effecting —
any change to any particulars provided in relation to the registration of the oral dental gum, including but not limited to the specifications, ingredients, formulation, composition or presentation of the oral dental gum; or
any change that may affect the safety of the oral dental gum.
Subregulation 2
An application for the Authority’s approval under paragraph (1) must —
be made in the form and manner specified on the Authority’s website;
be submitted within such time as the Authority may specify in the conditions of the registration of the oral dental gum;
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
if required by the Authority, be accompanied by a statutory declaration by the registrant verifying any information contained in or relating to the application.
Subregulation 3
A registrant 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 4
A registrant who —
in compliance or purported compliance with paragraph (2), furnishes the Authority with any information under that paragraph which the registrant knows is false or misleading; or
supplies or causes to be supplied any oral dental gum that is subject to the proposed change before the Authority has given its approval for the change, 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.