30. Changes affecting licences

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.

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.

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.

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.

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.

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.

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.

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.