Health Products (Active Ingredients) Regulations 2023 · As enacted · Part 2 · Prohibition Against Dealing with Adulterated,Counterfeit, Etc., Active Ingredients
4. Prohibition against manufacture of adulterated, counterfeit or unwholesome active ingredients
Feedback & supportSubject to paragraph (2), a person must not manufacture, or procure or arrange for the manufacture of, any active ingredient that is —
an adulterated active ingredient;
a counterfeit active ingredient; or
an unwholesome active ingredient.
Paragraph (1)(c) does not apply in relation to an active ingredient that is unwholesome only by reason of the active ingredient —
not being in conformity as regards quality or purity with the specifications of its manufacturer; or
having a standard of quality or purity which falls below or which differs from, that which is represented on its label.
In any proceedings for an offence under section 47(4) of the Act for a contravention of paragraph (1), 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 active ingredient is not an adulterated, counterfeit or unwholesome active ingredient.
Subregulation 1
Subject to paragraph (2), a person must not manufacture, or procure or arrange for the manufacture of, any active ingredient that is —
an adulterated active ingredient;
a counterfeit active ingredient; or
an unwholesome active ingredient.
Subregulation 2
Paragraph (1)(c) does not apply in relation to an active ingredient that is unwholesome only by reason of the active ingredient —
not being in conformity as regards quality or purity with the specifications of its manufacturer; or
having a standard of quality or purity which falls below or which differs from, that which is represented on its label.
Subregulation 3
In any proceedings for an offence under section 47(4) of the Act for a contravention of paragraph (1), 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 active ingredient is not an adulterated, counterfeit or unwholesome active ingredient.