COMMONWEALTH OF AUSTRALIA
Department of Health and Ageing
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTIONS 14 and 14A NOTICE
On 20 August 2013, the Delegate of the Secretary of the Department of Health and Ageing gave consent, pursuant to sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act), to the following:
- The supply, importation and exportation of the therapeutic goods or classes of therapeutic goods specified in Column 2 of the Table and with the Australian Register of Therapeutic Goods number (ARTG No.) specified in Column 3 of the Table; and
- Without conforming to those clauses, specified in Column 5 of the Table, of the standard, specified in the Column 4 of the Table otherwise applicable to the goods.
Pursuant to section 15(1) of the Act, consent is subject to the conditions specified in Column 6 of the Table and consent is given for the period specified in Column 7 of the Table, provided all other requirements of the standard are met.
Column 1 | Column 2 | Column3 | Column 4 | Column 5 | Column 6 | Column 7 |
Sponsor | Goods or Classes of Goods | ARTG No. | Standard | Clauses | Conditions | Period for which consent is given |
Bayer Australia Ltd | Elevit | 213113 | TGO 78 | 11(a) | The goods are not required to comply with TGO 78 section 11(a) but must comply with the requirements of the British Pharmacopoeia Appendix XII C Uniformity of Weight (Mass). | Until further notice. |
Bayer Australia Ltd | Elevit | 213113 | TGO 78 | 11(b) | The goods are not required to comply with TGO 78 section 11(b) but the average content of each active ingredient in the goods must comply with the relevant acceptance criteria included in Table 1. | Until further notice. |
Bayer Australia Ltd | Elevit | 213113 | TGO 78 | 11(c) | The goods are not required to comply with TGO 78 section 11(c) but must comply with the dissolution requirements of the United States Pharmacopeia-National Formulary, Dietary Supplement Chapter <2040> ‘Disintegration and Dissolution of Dietary Supplements’ for riboflavine (Vitamin B2) and iron. | Until further notice. |
Table 1: Acceptance criteria for Assay of Active ingredients
Active ingredient | Label Claim (LC) | Units for LC | Acceptance criteria in units of label claim | Acceptance criteria in units of percentage of label claim |
Thiamine (Vitamin B1, as thiamine nitrate) | 1.4 | mg | 1.26 | 1.69 | 90.0 | 120.7 |
Riboflavine (Vitamin B2) | 1.4 | mg | 1.26 | 1.69 | 90.0 | 120.7 |
Nicotinamide | 18 | mg | 16.2 | 20.8 | 90.0 | 115.6 |
Pantothenic acid (Vitamin B5, as calcium pantothenate) | 6 | mg | 5.4 | 7.3 | 90.0 | 121.7 |
Pyridoxine (Vitamin B6, as pyridoxine hydrochloride) | 1.9 | mg | 1.71 | 2.30 | 90.0 | 121.1 |
Cyanocobalamin (Vitamin B12) | 2.6 | µg | 2.34 | 3.70 | 90.0 | 142.3 |
Ascorbic Acid (Vitamin C) | 85 | mg | 76.5 | 102.9 | 90.0 | 121.1 |
Cholecalciferol (Vitamin D3 200 IU) | 5 | µg | 4.5 | 7.4 | 90.0 | 148.0 |
dl-alpha tocopherol (Vitamin E, as dl-alpha tocopheryl acetate) | 18.7 | mg | 16.83 | 24.68 | 90.0 | 132.0 |
Biotin (Vitamin H) | 30 | µg | 27.0 | 38.0 | 90.0 | 126.7 |
Folic acid | 800 | µg | 720.0 | 1056.0 | 90.0 | 132.0 |
Calcium (as calcium hydrogen phosphate anhydrous, calcium pantothenate and calcium carbonate) | 125 | mg | 113.0 | 138.0 | 90.4 | 110.4 |
Copper (as cupric sulfate anhydrous) | 1 | mg | 0.9 | 1.1 | 90.0 | 110.0 |
Iodine (as potassium iodide) | 220 | µg | 198.0 | 253.0 | 90.0 | 115.0 |
Iron (as ferrous fumarate) | 60 | mg | 54.0 | 66.0 | 90.0 | 110.0 |
Magnesium (as magnesium oxide – heavy and magnesium stearate) | 100 | mg | 90.0 | 110.0 | 90.0 | 110.0 |
Manganese (as manganese sulfate monohydrate) | 1.9 | mg | 1.71 | 2.38 | 90.0 | 125.3 |
Selenium (as sodium selenite) | 50 | µg | 45.0 | 55.0 | 90.0 | 110.0 |
Zinc (as zinc citrate trihydrate) | 11 | mg | 9.9 | 12.1 | 90.0 | 110.0 |
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply, importation, and exportation of therapeutic goods within Australia, ensuring that these goods meet certain quality, safety, and efficacy standards. The Act was introduced to address the need for a cohesive framework to govern the therapeutic goods industry, thereby protecting public health. The Therapeutic Goods Administration (TGA) is the relevant body responsible for administering the Act, with the overarching policy objective being to safeguard the health of Australians by regulating therapeutic goods. On 20 August 2013, the Delegate of the Secretary of the Department of Health and Ageing provided consent under sections 14 and 14A of the Act, allowing the supply, importation, and exportation of specific therapeutic goods by Bayer Australia Ltd. This consent was granted for certain classes of therapeutic goods, specifically Elevit 213, which have been assigned an Australian Register of Therapeutic Goods number (ARTG No. 13113). The consent permits deviations from specific clauses of the Therapeutic Goods Order No. 78, subject to certain conditions and acceptance criteria, and is effective until further notice.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, including their supply, importation, and exportation. The Act governs the therapeutic goods industry, ensuring that therapeutic goods available in Australia are of an acceptable quality and are safe for use. The Act applies to entities such as manufacturers, importers, sponsors, and suppliers of therapeutic goods within Australia's jurisdiction, encompassing a wide range of products including prescription and non-prescription medicines, medical devices, blood and blood components, tissues, and vaccines. The Act's application extends nationally, with the Therapeutic Goods Administration (TGA) being the regulatory authority under the Commonwealth of Australia. Certain exclusions and exemptions may apply, particularly to goods that are for personal use or research purposes, and specific provisions may be outlined in subordinate instruments or guidelines issued by the TGA. The legislation allows for the granting of consents, such as the one issued to Bayer Australia Ltd for the supply, importation, and exportation of specific therapeutic goods with certain conditions and exemptions from particular standards, ensuring compliance with other applicable requirements.
Key Provisions
Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) allow the Delegate of the Secretary of the Department of Health and Ageing to give consent for the supply, importation, and exportation of certain therapeutic goods, provided the specified conditions are met. In this case, Bayer Australia Ltd was granted consent to supply, import, and export the therapeutic goods 'Elevit 21' (ARTG No. 13113) without complying with certain clauses of the applicable standard (TGO 78). Instead, the goods must meet other specified requirements, such as complying with the British Pharmacopoeia Appendix XII C Uniformity of Weight (Mass) or the United States Pharmacopeia-National Formulary, Dietary Supplement Chapter <2040> 'Disintegration and Dissolution of Dietary Supplements' for specific active ingredients.
The obligations imposed by the Act on Bayer Australia Ltd include ensuring that the 'Elevit 21' goods meet the specified conditions, such as adhering to the British Pharmacopoeia Appendix XII C Uniformity of Weight (Mass) for weight uniformity, and the United States Pharmacopeia-National Formulary, Dietary Supplement Chapter <2040> 'Disintegration and Dissolution of Dietary Supplements' for riboflavine (Vitamin B2) and iron. Additionally, the active ingredient content must comply with the acceptance criteria outlined in Table 1. Bayer Australia Ltd must also ensure that all other requirements of the applicable standard (TGO 78) are met.
Failure to comply with the conditions specified in sections 14 and 14A of the Therapeutic Goods Act 1989 may result in civil or criminal penalties. The Act does not specify maximum penalties for breaches of these sections, but breaches of the Act generally may result in fines, imprisonment, or both, depending on the severity of the offence. Additionally, the Therapeutic Goods Administration may take enforcement action, such as recalls or prohibitions on the supply of the non-compliant goods.