Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 · As enacted · Part 8 · Duties and Obligations of Manufacturers, Importers, Etc., of Ctgt Products
45. Changes affecting licences
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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.
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.
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.
An application for the Authority’s approval under paragraph (3) must be made in the form and manner specified on the Authority’s website.
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.
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.
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.
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.