Thursday, April 21, 2016

Singapore - Health Products (Cosmetic Products — Asean Cosmetic Directive) Regulations – Part IV

PART IV
ADDITIONAL DUTIES AND OBLIGATIONS
Duty to maintain records of supply
10.
—(1)  The person responsible for placing a cosmetic product in the market shall —
(a)
keep records of any supply of the cosmetic product, whether supplied by him or supplied on his behalf in Singapore; and
(b)
produce such records for inspection by the Authority or an enforcement officer as and when required by the Authority or enforcement officer.
(2)  The records referred to in paragraph (1) shall —
(a)
contain the following information:
(i)
the name and notification number of the cosmetic product that was supplied;
(ii)
the date on which the cosmetic product was so supplied;
(iii)
the name and address of the person to whom the cosmetic product was so supplied;
(iv)
the quantity of the cosmetic product so supplied; and
(v)
the identification number or mark (including the control number, lot number, batch number or serial number) of the cosmetic product so supplied; and
(b)
be retained by the person responsible for placing the cosmetic product in the market for a period of 2 years after the date on which the cosmetic product is so supplied.
(3)  Any person who contravenes paragraph (1) or (2) 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.
(4)  Any person who, in compliance or purported compliance with paragraph (1)(b), furnishes the Authority or an enforcement officer with any record 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.
Reporting of defects and adverse effects to Authority
11.
—(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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