Singapore legislation
Clause 42
Clause 42
Reporting of defects and adverse effects to Authority
(1)
Where the manufacturer, importer, supplier or registrant of a health product becomes aware of ––
any defect in the health product; or
any adverse effect that has arisen or can arise from the use of the health product,it shall be the duty of such person to inform the Authority within the prescribed time of the defect or adverse effect.
(2)
Where the Authority receives any information under subsection (1) concerning any defect in, or adverse effect of, a health product or becomes aware of any such defect or adverse effect through any other means, it may take any one or more of the following actions:
by notice in writing require the manufacturer, importer, supplier or registrant of the health product to investigate into the defect or adverse effect and make a report of his findings and recommendations to the Authority;
by notice in writing 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 defect or adverse effect and the measures that should be taken for addressing such defect or adverse effect;
by notice in writing require the manufacturer, importer, supplier or registrant of the health product to recall the health product and take such measures as the Authority may specify to secure the immediate stoppage of the manufacture, import, supply, use or administration (as the case may be) of the health product;
by notice in writing prohibit any person from using or administering the health product and require such person to take such measures as the Authority may specify to address any adverse effect that may have arisen from any previous use or administration of the health product;
by notice in writing require the manufacturer, importer, supplier or registrant of the health product to take such other measures as the Authority thinks necessary in the circumstances.
(3)
The Authority may also in any notice in writing given under subsection (2) require the person to whom the notice has been given to submit to the Authority in such form and manner and within such time and for such period as the Authority may specify, a report containing information on —
the measures that he has taken under the order;
the results of the measures so taken; and
any other matter as the Authority thinks necessary or relevant in the circumstances.
(4)
A statement under subsection (2)(b) shall be issued in such form and manner as the Authority may require, including —
by publication in any one or more daily newspapers circulating in Singapore; or
by dissemination in such alternative medium,within such time and for such period as the Authority may determine.
(5)
Any person who —
fails to comply with subsection (1) or a notice given to him by the Authority under subsection (2) or (3); or
in compliance or purported compliance with subsection (1) or a notice given to him by the Authority under subsection (2) or (3), furnishes the Authority with any information or document 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.
(6)
For the purposes of this section, a health product has a defect if —
it has or has possibly been adulterated or tampered with;
it is or is possibly a counterfeit or an unwholesome health product;
it is or is possibly of inadequate quality or unsafe or inefficacious for its intended purpose; or
it fails or could possibly fail to satisfy such other standards or requirements as may be prescribed.