Singapore legislation
Regulation 49
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 49
Information on validity of data submitted to or considered by Authority
Subregulation 1
A registrant of a CTGT product must, within 15 days after receiving any information that adversely affects the validity of any data provided by the registrant to the Authority relating to the quality, safety or efficacy of the CTGT product, inform the Authority of that information.
Subregulation 2
A registrant of a CTGT product 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 of a CTGT product who, in compliance or purported compliance with paragraph (1), provides the Authority with any information which the registrant knows is false or misleading in a material particular, 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.