Singapore legislation
Regulation 42
Regulation 42
Changes concerning registered therapeutic product
Subregulation 1
A registrant of a registered therapeutic 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 prior approval from the Authority before effecting —
any change to any particulars provided in relation to the registration of the therapeutic product; or
any change that may affect the quality, safety or efficacy of the therapeutic product.
Subregulation 2
An application for the Authority’s approval under paragraph (1) must —
be made in such form and manner as the Authority may require;
be submitted within such time as the Authority may specify in the conditions of the registration of the therapeutic product;
be accompanied by such particulars, information, documents and samples as the Authority may require;
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 therapeutic product must ensure that no supply is made of the therapeutic 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 therapeutic 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 therapeutic product who —
in compliance or purported compliance with paragraph (1), furnishes the Authority with any information under paragraph (1) which the registrant knows is false or misleading; 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.