Health Products Act 2007 · 2020 Revised Edition · Part 8 · Duties of Manufacturers, Importers, Etc., of Health Products
44. Notification to Authority concerning recall of health product
Feedback & supportWhere the manufacturer, importer, supplier or registrant of a health product recalls or intends to recall the health product, such person must, within the prescribed time, notify the Authority of the recall or intended recall and the reasons for it.
registrant
“registrant”, in relation to a registered health product, means the person who applied for and obtained the registration of the health product under this Act;
On being notified of the recall or intended recall of a health product under subsection (1), the Authority may, by written notice, require the manufacturer, importer, supplier or registrant of the health product to issue or cause to be issued to such persons as the Authority may specify or to the general public a statement informing them of the recall of the health product and any other matter as the Authority considers necessary.
recall
“recall”, in relation to a health product, means any action taken by its manufacturer, importer, supplier or registrant to remove the health product from the market or to retrieve the health product from any person to whom it has been supplied, because the health product —(a)may be hazardous to health;(b)may fail to conform to any claim made by its manufacturer or importer relating to its quality, safety or efficacy; or(c)may not meet the requirements of this Act;
Any person who —
fails to comply with subsection (1) or a notice given to the person by the Authority under subsection (2); or
in compliance or purported compliance with subsection (1), furnishes the Authority with any information or document which the person knows is false or misleading,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.