Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 · As enacted · Part 8 · Duties and Obligations of Manufacturers, Importers, Etc., of Ctgt Products
46. Changes affecting notices
Feedback & supportA known manufacturer, known importer or known wholesaler of a CTGT product must —
inform the Authority in writing of any change in any information earlier provided in the notice given by the known manufacturer, known importer or known wholesaler under regulation 4, 7, 10 or 16 (as the case may be), within 14 days after that change occurred; and
give notice to the Authority that the person has ceased to manufacture, import or supply (as the case may be) the CTGT product in the form and manner specified on the Authority’s website.
A person 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 1
A known manufacturer, known importer or known wholesaler of a CTGT product must —
inform the Authority in writing of any change in any information earlier provided in the notice given by the known manufacturer, known importer or known wholesaler under regulation 4, 7, 10 or 16 (as the case may be), within 14 days after that change occurred; and
give notice to the Authority that the person has ceased to manufacture, import or supply (as the case may be) the CTGT product in the form and manner specified on the Authority’s website.
Subregulation 2
A person 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.