Section 14 and 14a Notice
Between 5th June 2012 and 17th September 2012, 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 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 | Column 3 | Column 4 | Column5 | Column 6 | Column 7 |
Sponsor | Goods or Classes of Goods | ARTG No. | Standard | Clause | Conditions | Period for which consent is given |
Bayer Australia Ltd | Elevit with Iodine | 174543 | TGO 78 | 11(b) | The estimated average content for each following active ingredient must fall within the respective percentage range relative to the stated content of that active ingredient: Calcium (90 to 110%), phosphorus (90 to 110%), iodine (90 to 110%), copper (90 to 125%), iron (90 to 110%), magnesium (90 to 110%), zinc (90 to 110%), folic acid (90 to 125%), ascorbic acid (90 to 121%), nicotinamide (90 to 115.5%), dl-alpha tocopheryl acetate (90 to 121%), cholecalciferol (90 to 132%), pyridoxine hydrochloride (90 to 121.2%), calcium pantothenate (90 to 115.5%), riboflavine (90 to 121.1%), thiamine nitrate (87.5 to 117.5%), cyanocobalamin (85 to 138%) and biotin (85 to 126.5%). | Goods released for supply prior to 31 July 2013 |
Bayer Australia Ltd | Elevit with Iodine | 174543 | TGO 78 | 11(c) | There are no dissolution requirements for any active ingredient except for folic acid. | Goods released for supply prior to 31 July 2013 |
Pfizer Australia Pty Ltd | Centrum Advance | 193683 | TGO 78 | 10(b) | The upper limits of the active ingredients lutein and lycopene are not more than 165% of the stated content, rather than the required 120%. | Until further notice |
Centrum Advance 50+ | 193642 |
Bausch & Lomb Australia Pty Ltd | Ocuvite Adult 50+ Capsule | 198670 | TGO 78 | 10(b) | The upper limit in the goods of: - Lutein is not more than 135% of the stated content, rather than the required 120%, and
- Zeaxanthin is not more than 190% of the stated content, rather than the required 120%.
| Until further notice |
GNLD | Pro Vitality + | 198326 | TGO 69 | 3(2) | The active ingredients and quantities are not required to be on the individual packets, provided that all other requirements of the Order, including maximum text height are met. | Until further notice |
Blackmores Limited | Blackmores Alive! Men’s Multivitamin | 198733 | TGO 69 | 3(2)(g) | The sponsor may supply, import or export the goods with a product label that does not include the Required Advisory Statements for Medicine Labels (RASML) statements 32 and 33: - ‘WARNING – When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.’
- ‘If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor of pharmacist.’
Additionally the label can include the following abridged version of RASML statement 31: - ‘The recommended daily amount of vitamin A from all sources is 900 micrograms retinol equivalents for men.’
| Until further notice |
Blackmores Alive! Men’s 50+ Multivitamin | 199198 |
Sanofi-Aventis Consumer Healthcare | Golden Glow Men’s One a day Multivitamin | 199301 | TGO 69 | 3(2)(g) | The sponsor may supply, import or export the goods with a product label that does not include the Required Advisory Statements for Medicine Labels (RASML) statements 32 and 33: - ‘WARNING – When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.’
- ‘If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor of pharmacist.’
Additionally the label can include the following abridged version of RASML statement 31: ‘The recommended daily amount of vitamin A from all sources is 900 micrograms retinol equivalents for men.’ | Until further notice |
Pfizer Australia Pty Ltd | Centrum for Men | 200421 | TGO 69 | 3(2)(g) | The sponsor may supply, import or export Centrum for Men – AUST L 200421 with a product label that does not include the Required Advisory Statements for Medicine Labels (RASML) statements 32 and 33: - ‘WARNING – When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.’
- ‘If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor of pharmacist.’
Additionally the label can include the following abridged version of RASML statement 31: ‘The recommended daily amount of vitamin A from all sources is 900 micrograms retinol equivalents for men.’ | Until further notice |
Pfizer Australia Pty Ltd | Centrum for Women | 200414 | TGO 69 | 3(2)(g) | The sponsor may supply, import or export Centrum for Women – AUST L 200214, with a label that includes the following abridged version of RASML statement 31: ‘The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women.' | Until further notice |
Prinz Herget Pty Ltd T/A Natural Therapy Imports | Mutaflor capsules | 194957 | TGO 69 | 3(13)(a) | The particulars referred to in subclause 3(13)(a) must appear on the blister pack label except the batch number and expiry date may be void of the required prefixes. | Applicable to Batch 221590 only |
Overview
The Therapeutic Goods Act 1989 (the Act) was enacted to provide a regulatory framework for the control of therapeutic goods in Australia, ensuring their safety, quality, and efficacy. The Act was introduced to address the need for a comprehensive legislative framework that would govern the manufacturing, supply, and importation of therapeutic goods, including medicines, medical devices, and blood and blood components. The Act was enacted by the Parliament of Australia, and its primary policy objective is to protect public health by ensuring that therapeutic goods available in Australia are of an acceptable standard.
The Therapeutic Goods Act 1989 provides a mechanism for the regulation of therapeutic goods through the Therapeutic Goods Administration (TGA), which is responsible for administering the Act. The Act allows the TGA to grant consent for the supply and importation of therapeutic goods that do not conform to certain standards, subject to specific conditions. This mechanism is intended to provide flexibility in the regulation of therapeutic goods, while still ensuring that they meet acceptable standards of safety, quality, and efficacy. The consent granted by the TGA is subject to the conditions specified in the Act, and is given for a specified period, provided all other requirements of the standard are met.
Scope and Application
The Therapeutic Goods Act 1989 (the Act) governs the regulation of therapeutic goods in Australia. Section 14 and 14A of the Act provides a mechanism whereby the delegate of the Secretary of the Department of Health and Ageing can give consent for the supply or importation of therapeutic goods without conforming to certain clauses of the standards otherwise applicable to the goods. This consent is given subject to specified conditions and for a defined period. The Act applies to therapeutic goods and their sponsors, which can include individuals and companies involved in the manufacture, supply, importation, or exportation of these goods. The geographic reach of the Act is national, applying across Australia, and it extends to all therapeutic goods within the country. The Act does not specify exclusions or thresholds in the provided text, but it allows for the modification of certain standards through subordinate instruments, which can be tailored to specific goods and their respective requirements. The consent granted under section 14A is specific to the goods listed in the Table, with each entry detailing the sponsor, the goods or classes of goods, the ARTG number, the applicable standard, the clause of the standard not to be conformed to, the conditions of consent, and the duration of consent.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) authorises the Secretary of the Department of Health and Ageing to give consent to the supply or importation of therapeutic goods under certain conditions (s 14). Between 5th June 2012 and 17th September 2012, the delegate of the Secretary gave consent to specified therapeutic goods to be supplied or imported without full compliance to certain clauses of the standards that otherwise apply to them. This consent is subject to specific conditions and is valid for a set period (s 15). For example, Bayer Australia Ltd was granted consent to supply Elevit with Iodine with specific conditions on the active ingredient content and dissolution requirements, valid until 31 July 2013 (Table, Column 6 and 7).
Entities granted consent under the Act must adhere to the specific conditions outlined in the consent. For instance, Bayer Australia Ltd must ensure the active ingredients in Elevit with Iodine fall within specified percentage ranges relative to the stated content (Table, Column 6). Similarly, Pfizer Australia Pty Ltd must ensure the upper limits of lutein and lycopene in Centrum Advance are not more than 165% of the stated content, rather than the required 120%. These conditions must be strictly followed to maintain the validity of the consent and to ensure the therapeutic goods meet the necessary safety and quality standards.
Failure to comply with the conditions of consent can result in legal consequences. The Act provides for both civil and criminal penalties for non-compliance. For example, under section 14A(3), any person who contravenes a condition of consent may be guilty of an offence. The maximum penalties can include fines and imprisonment, depending on the severity of the breach. Additionally, the Therapeutic Goods Administration may take enforcement actions such as seizing non-compliant goods or imposing additional administrative penalties.
In summary, the Therapeutic Goods Act 1989 allows for consent to be given for the supply or importation of therapeutic goods under specific conditions. Entities granted such consent must comply with these conditions to avoid legal consequences, which can include substantial fines and imprisonment. The Act ensures that therapeutic goods entering the market meet necessary safety and quality standards, thereby protecting public health.