Singapore legislation

Section 40

of Health Products Act 2007

Section 40

Keeping of records

(1)

The Authority may, by written notice, require the manufacturer, importer, supplier or registrant of a health product —

(a)

to keep such records as the Authority may determine in relation to the manufacture, import, supply, use or administration (as the case may be) of the health product; and

(b)

to 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 mentioned in subsection (1) must be kept in such form and manner and for such period as the Authority may stipulate, and must contain such information in relation to the manufacture, import, supply, use or administration (as the case may be) of the health product as the Authority may require.

(3)

Any person who fails to comply with any requirement under subsection (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 subsection (1)(b), furnishes the Authority or an enforcement officer with any record 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.