Health Products (Active Ingredients) Regulations 2023 · As enacted · Part 2 · Prohibition Against Dealing with Adulterated,Counterfeit, Etc., Active Ingredients
5. Prohibition against import or supply of adulterated, counterfeit, etc., active ingredients
Feedback & supportA person must not import or supply, or procure or arrange for the import or supply of, any active ingredient that is —
an adulterated active ingredient;
a counterfeit active ingredient;
an active ingredient that has been tampered with; or
an unwholesome active ingredient.
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 —
did not know;
had no reason to believe; and
could not, with reasonable diligence, have ascertained,that the active ingredient was an adulterated active ingredient, a counterfeit active ingredient, an active ingredient that has been tampered with or an unwholesome active ingredient; and
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 active ingredient, a counterfeit active ingredient, an active ingredient that has been tampered with or an unwholesome active ingredient.
Subregulation 1
A person must not import or supply, or procure or arrange for the import or supply of, any active ingredient that is —
an adulterated active ingredient;
a counterfeit active ingredient;
an active ingredient that has been tampered with; or
an unwholesome active ingredient.
Subregulation 2
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 —
did not know;
had no reason to believe; and
could not, with reasonable diligence, have ascertained,that the active ingredient was an adulterated active ingredient, a counterfeit active ingredient, an active ingredient that has been tampered with or an unwholesome active ingredient; and
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 active ingredient, a counterfeit active ingredient, an active ingredient that has been tampered with or an unwholesome active ingredient.