Singapore legislation
Regulation 30
Regulation 30
Changes affecting licences
Subregulation 1
A licensee 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 submitted within the time that the Authority specifies in the conditions of the licence;
be accompanied by the particulars, information, documents and samples as the Authority may require;
be accompanied by the relevant fee specified in the Health Products (Fees) Regulations 2022 (G.N. No. S 450/2022); 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
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 29.