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Reporting of defects and adverse effects to Authority

Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007

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Wrong or mistyped textWrong structure or numberingWrong title or detailsDuplicated content

Proposed text

—(1) If the person responsible for placing a cosmetic product in the market becomes aware of any event or other occurrence that concerns any adverse effect arising from the use of the cosmetic product, he shall —(a)if the adverse effect has caused death or is life-threatening —(i)inform the Authority of the event or occurrence no later than 7 days after the supplier first becomes aware of the event or occurrence; and(ii)submit a detailed report on the event or occurrence to the Authority within 8 days after the initial report made under sub-paragraph (i); or(b)if the adverse effect has resulted in any person being hospitalised or has caused any persistent or significant disability or incapacity in any person, submit a detailed report on the event or occurrence to the Authority no later than 15 days after the supplier first becomes aware of the event or occurrence.(2) If the person responsible for placing a cosmetic product in the market becomes aware of any event or other occurrence that reveals any defect in the cosmetic product, he shall —(a)if the defect may cause death or may be life-threatening —(i)inform the Authority of the event or occurrence no later than 7 days after the supplier first becomes aware of the event or occurrence; and(ii)submit a detailed report on the event or occurrence to the Authority within 8 days after the initial report made under sub-paragraph (i); or(b)if the defect may result in any person being hospitalised or may cause any persistent or significant disability or incapacity in any person, submit a detailed report on the event or occurrence to the Authority no later than 15 days after the supplier first becomes aware of the event or occurrence.(3) The reports referred to in paragraph (1) or (2) shall be in such form and manner, and shall contain such information in relation to the adverse effect or defect, as the Authority may require.(4) Any person who —(a)fails to comply with paragraph (1) or (2); or(b)in compliance or purported compliance with paragraph (1) or (2), furnishes the Authority with any information or report which he 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.

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