Section 14 and 14a Notice
R12/ 1048892
Between 18th September 2012 and 24th December 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 |
Pfizer Australia Pty Ltd | Centrum for Men | 200421 | TGO 78 | 10(b) | The upper limit for the contents of lutein and lycopene in the tablets can increase from 120% to 165.0% of the stated content. | Until further notice |
Centrum for Women | 200414 |
Health World Limited | Metagenics Estrofactors | 197988 | TGO 78 | 10(b) | The upper limit of 150% for calcium folinate as specified in TGO 78 can be exceeded in one packaged batch made from bulk batch 15291 | Applicable to Batch 15291 only. |
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi-Aventis Consumer Healthcare | Cenovis Men’s Multi Performance | 202158 | TGO 69 | 3(2)(g) | Product label 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 or pharmacist.’
Label that includes 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. |
Pharmacare Laboratories Pty Ltd | Nature’s Way High Strength Olive Leaf 6000mg | 192703 | TGO 78 | | The upper limit of 120% for oleuropein can be waived. | Applicable to packaged batch made from bulk batch 15659 of capsules. |
Nestle Australia Ltd | Anticol Extra Strong | 203083 | TGO 69 | 3(12)(a) | The individual unsealed wrapper around each lozenge is not required to include the product name, the names of all the active ingredients and their quantities, provided the individual wrappers include the name of sponsor, and the outer label of the pack complies fully with TGO 69 | Until further notice |
Bausch & Lomb Australia Pty Ltd | Ocuvite Lutein capsules | 200282 | TGO 78 | | Adopt limits of 90.0 – 150.0% for the content of lutein in each capsule. | Until further notice. |
Overview
The Therapeutic Goods Act 1989 was enacted to provide a regulatory framework for the control of therapeutic goods in Australia, aiming to ensure that these goods are of acceptable quality, safety, and efficacy. The Act was introduced to address the need for a comprehensive legal structure to govern the manufacture, supply, and importation of therapeutic goods, thereby protecting public health. Enacted by the Parliament of Australia, the Act establishes the Therapeutic Goods Administration (TGA) to administer and enforce the provisions, with a policy objective of safeguarding the health and safety of the Australian population by regulating the therapeutic goods market. This legislation ensures that therapeutic goods available in Australia meet necessary standards and are appropriately advertised and labelled to inform consumers about their use and potential risks.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing a wide range of products including medicines, medical devices, blood, and tissues. The Act applies to individuals and entities such as sponsors and manufacturers who supply, import, or advertise therapeutic goods. The scope of the Act extends to all therapeutic goods within Australia, including those that are manufactured locally or imported into the country. Section 14 and 14A of the Act allow the Secretary of the Department of Health and Ageing to provide consent for certain therapeutic goods to be supplied or imported without full compliance to the Therapeutic Goods Order (TGO) standards, subject to specific conditions and for a defined period. The consent is given for specific therapeutic goods and allows for certain clauses of the TGO standards to be varied or waived. These consents are typically granted to accommodate unique circumstances or to facilitate access to certain therapeutic goods while still ensuring a level of safety and efficacy. The Act’s jurisdiction is national, applying uniformly across all states and territories in Australia. Subordinate instruments, such as the Therapeutic Goods Orders, provide additional detail and specifications that further define the application of the Act.
Key Provisions
Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) pertain to the circumstances under which consent may be given for the supply or importation of therapeutic goods that do not fully conform to certain standards. Specifically, section 14 allows the delegate of the Secretary of the Department of Health and Ageing to give consent for such supply or importation if certain conditions are met. Section 14A, meanwhile, sets out the conditions under which such consent may be granted. These provisions were exercised between 18 September 2012 and 24 December 2012, as evidenced in the notice (R12/ 1048892), allowing specified therapeutic goods to be supplied or imported without full compliance to the relevant standards, subject to certain conditions and for a specified period.
The Act imposes a variety of obligations on the parties involved, primarily the requirement to meet all conditions specified in the consent given by the delegate. For example, Pfizer Australia Pty Ltd was permitted to supply Centrum for Men and Centrum for Women without fully conforming to the specified standard, provided that the upper limit for lutein and lycopene content and calcium folinate could be exceeded under certain circumstances. Similarly, Health World Limited, Sanofi-Aventis Healthcare Pty Ltd, Pharmacare Laboratories Pty Ltd, Nestle Australia Ltd, and Bausch & Lomb Australia Pty Ltd were each granted consent to supply their respective products under conditions that deviated from the standard requirements. These conditions include modifications to product content, label statements, or the application of specific batch limits.
Failure to comply with the terms and conditions of the consent granted under sections 14 and 14A of the Act may result in various legal consequences. Although the notice does not explicitly state penalties, breaches of the Act generally incur civil or criminal penalties depending on the nature and severity of the offence. Civil penalties can include fines up to a significant amount as stipulated by the Act, while criminal penalties can result in imprisonment, particularly for more serious violations. The exact penalties are usually detailed in other sections of the Act or in related regulations.
In summary, sections 14 and 14A of the Therapeutic Goods Act 1989 allow for the supply or importation of therapeutic goods that do not fully conform to the applicable standards, subject to the delegate's consent and specific conditions. These conditions vary between products and include modifications to content limits, label statements, and batch-specific restrictions. Compliance with these conditions is mandatory, and failure to adhere to them may lead to legal penalties, including fines and imprisonment.