Consent given pursuant to Sections 14 and 14A for the supply of the therapeutic goods specified by Sanofi Aventis Healthcare

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 22 May 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare, gave consent to the supply of

• Nature's Own Folic Acid 500mcg (AUST L 90865)
• Cenovis Folic Acid 500mcg (AUST L 90869)

that does not conform with the requirements of the section 8 of the Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (TGO 78), in that the product(s) do not comply with the requirement of not less than 90.0 per cent and not more than 110.0 per cent of the of the stated content for folic acid as per the individual monograph for ‘Folic Acid Tablets’ of the British Pharmacopoeia (BP).

The consent applies to the following batches (table 1) but only until 15 September 2015. 

The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The content of the active ingredient 'Folic acid' must be not less than 90.0% and not more than 130.0% of the stated content on the label;