Singapore legislation
Regulation 45
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 45
Changes affecting licences
Subregulation 1
A licensee of a CTGT product must notify the Authority of —
any change or proposed change to any particulars provided by the licensee to the Authority in relation to the application for the licensee’s licence; and
any change or proposed change that significantly affects the activities of the licensee that are authorised by that licence.
Subregulation 2
A notice 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 licence;
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 licensee verifying any information contained in or relating to the notice.
Subregulation 3
A licensee must not, without the Authority’s approval, make any change that significantly affects the activities of the licensee that are authorised by the licensee’s licence.
Subregulation 4
An application for the Authority’s approval under paragraph (3) must be made in the form and manner specified on the Authority’s website.
Subregulation 5
For the purposes of paragraphs (1) and (3), a change that significantly affects the activities of a licensee that are authorised by the licensee’s licence includes a change of one or more of the following:
the premises where the licensee operates;
the operations and processes carried out by the licensee;
the responsible person mentioned in regulation 43.
Subregulation 6
A licensee 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 7
A licensee who —
in compliance or purported compliance with paragraph (1), provides the Authority with any notice which the licensee 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.