Singapore legislation

Regulation 27

of Health Products (Oral Dental Gums) Regulations 2016

Regulation 27

Information on validity of data submitted to or considered by Authority

Subregulation 1

A registrant of an oral dental gum must, within 15 days after receiving any information that adversely affects the validity of any data relating to the safety of the oral dental gum furnished by the registrant to the Authority at the time of the application to register the oral dental gum, inform the Authority of such information.

Subregulation 2

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 3

A registrant who, in compliance or purported compliance with paragraph (1), furnishes the Authority with any information which the registrant 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.