Singapore legislation
Regulation 48
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 48
Changes concerning registered CTGT products
Subregulation 1
A registrant of a registered CTGT product must, unless the change is of a type specified on the Authority’s website to be one for which the Authority’s approval is not required, obtain the Authority’s prior approval before effecting —
any change to any particulars provided in relation to the registration of the CTGT product; or
any change that may affect the quality, safety or efficacy of the CTGT product.
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 the time that the Authority specifies in the conditions of the registration of the CTGT product;
be accompanied by the particulars, information, documents and samples that the Authority requires;
be accompanied by the relevant fee; 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
Where the Authority’s approval is required under paragraph (1), the registrant of the CTGT product must ensure that no supply is made of the CTGT product that is subject to the proposed change until after the Authority has given its approval for the change.
Subregulation 4
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 5
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; or
fails to comply with paragraph (3),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.