Health Products Act 2007 · 2020 Revised Edition · Part 3 · Manufacture and Import of Health Products
12. Manufacture of health products
Feedback & supportExcept in such cases as may be prescribed, a person must not manufacture any health product unless —
manufacture
“manufacture”, in relation to a health product, means to make, fabricate, produce or process the health product and includes —(a)any process carried out in the course of so making, fabricating, producing or processing the health product; and(b)the packaging and labelling of the health product before it is supplied;
the person holds a valid manufacturer’s licence; and
the manufacture of the health product is carried out in accordance with the conditions of the licence.
A manufacturer’s licence does not authorise the holder of the licence to supply any health product manufactured by the holder to any other person unless the health product so manufactured by the holder is a registered health product.
A person must not use any premises or facility for the manufacture of any health product unless the premises or facility is authorised for such use under the person’s manufacturer’s licence or the provisions of this Act, or by the Authority.
health product
“health product” means any substance, preparation or device —(a)that —(i)is represented for use by humans;(ii)whether because of its presentation or otherwise, is likely to be taken for use by humans; or(iii)is included in a class of substances, preparations or devices which are or are ordinarily intended for use by humans,solely or principally for a health-related purpose; and(b)that falls within any of the categories of health products specified in the First Schedule;
Every manufacturer of a health product must ensure that the manufacture of the health product is carried out in accordance with such requirements as may be prescribed.
A person must not manufacture, or procure or arrange for the manufacture of, any health product which is —
an adulterated health product;
a counterfeit health product; or
an unwholesome health product.
Any person who contravenes subsection (1), (3), (4) or (5) shall be guilty of an offence and shall be liable on conviction —
in the case of an offence under subsection (1), (3), (4) or (5)(c), to a fine not exceeding $50,000 or to imprisonment for a term not exceeding 2 years or to both; and
in the case of an offence under subsection (5)(a) or (b), to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 3 years or to both.
In any proceedings for an offence under subsection (5), it is a defence for the accused to prove that the accused had taken all such precautions and exercised all such due diligence as could reasonably be expected of the accused in the circumstances to ensure that the health product did not contravene that subsection.