COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 24 September 2015, a delegate of the Secretary of the Department of Health, on the application of Bayer Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of:
ARTG Registration Number | ARTG Name |
91116 | AERIUS desloratadine 5mg tablet |
97260 | AERIUS FOR CHILDREN SYRUP desloratadine 2.5mg/5ml oral liquid |
53516 | CLARATYNE-D WITH DECONGESTANT tablet |
136194 | DEMAZIN CHESTY COUGH RELIEF SYRUP oral liquid |
97036 | DEMAZIN COLD & FLU tablet |
97031 | DEMAZIN COUGH, COLD & FLU tablet |
18813 | DEMAZIN COLD RELIEF BLUE SYRUP bottle |
57378 | DEMAZIN COLD RELIEF COLOUR FREE SYRUP bottle |
151700 | DEMAZIN COUGH & COLD RELIEF SYRUP bottle |
133205 | DEMAZIN DAY & NIGHT COLD & FLU tablet |
218997 | DEMAZIN 12 HOUR RELIEF NASAL SPRAY oxymetazoline hydrochloride |
161596 | DRIXINE DECONGESTANT NASAL SPRAY oxymetazoline hydrochloride |
181889 | DRIXINE NO DRIP FORMULA MENTHOL AROMA PUMP MIST NASALSPRAY oxymetazoline hydrochloride 500mcg/ml |
179875 | DRIXINE NO DRIP FORMULA MOISTURISING PUMP MIST NASAL SPRAY oxymetazoline hydrochloride 500mcg/ml |
166852 | DRIXINE NO DRIP FORMULA ORIGINAL PUMP MIST NASAL SPRAY oxymetazoline hydrochloride 500mcg/ml |
that will not conform to the requirements of paragraph 3(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicine, in that the medicine labels do not include all of the advisory statements that are required by schedule 2 of the Medicines Advisory Statements Specification 2014 (the Specification), which is due to come into effect on 12 December 2015.
In particular, the labels of the medicines do not include the following advisory statements required by the Specification (or alternative statements that fully convey the same intent), as applicable:
- For the medicines containing pseudoephedrine: ‘This product may cause sleeplessness if it is taken up to several hours before going to bed.’
- For the medicines containing desloratadine: ‘If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine’.
- For the medicines containing oxymetazoline: ‘Do not give to children aged between 6 and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner’.
- For the DEMAZIN oral liquid medicines: ‘Do not give to children aged between 6 and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner’.
- For the DEMAZIN oral liquid medicines containing phenylephrine: ‘This product may cause sleeplessness’.
The consent is effective from 12 December 2015 until 12 December 2016.
The consent is subject to the following condition:
- The labels to which this consent applies are those previously approved by the TGA for the former sponsor Merck Sharp & Dohme (Australia).
Overview
The Therapeutic Goods Act 1989 was enacted to ensure that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy. It was introduced to address the need for comprehensive regulation of therapeutic goods, including medicines, medical devices, and blood and blood components, to protect public health. This Act provides the legal framework for the regulation of therapeutic goods, ensuring that they are safe and of acceptable quality, and that information about these goods is available to health professionals and consumers. The Therapeutic Goods Administration (TGA), as the delegate of the Secretary of the Department of Health, administers this Act, with the overarching policy objective being to safeguard public health by ensuring that therapeutic goods are safe, of high quality, and that their benefits outweigh any risks.
In a specific instance, the TGA granted a consent under sections 14 and 14A of the Therapeutic Goods Act 1989 for Bayer Australia Pty Ltd to import and supply certain medicines that do not conform to the requirements of Therapeutic Goods Order No. 69 concerning the inclusion of certain advisory statements on medicine labels. This consent was effective from 12 December 2015 until 12 December 2016, subject to conditions that aimed to mitigate any potential risks associated with the non-compliance of the product labels with the regulatory requirements.
Scope and Application
The Therapeutic Goods Act 1989 applies to a wide array of therapeutic goods, encompassing medicines, medical devices, blood, tissues, and other related products, as well as their advertising and labelling. The Act governs entities such as manufacturers, importers, suppliers, and sponsors of these goods, as well as individuals and businesses involved in the supply chain, ensuring that all therapeutic goods meet certain safety, quality, and efficacy standards before they can be marketed or supplied in Australia. This Act applies nationally across the Commonwealth of Australia and is enforced by the Therapeutic Goods Administration (TGA), which is a part of the Department of Health. The Act’s jurisdictional reach is thus comprehensive, applying to all therapeutic goods regardless of where they are manufactured, imported, or supplied within Australia. There are, however, specific exclusions and exemptions outlined in the Act, such as goods for personal use, prescribed medical devices for clinical trials, and blood products for personal use. Additionally, the Act allows for certain therapeutic goods to be exempt from some of its provisions under specific circumstances, such as for research and testing purposes or for clinical trials. The scope of the Act can be extended or restricted through subordinate instruments, such as therapeutic goods regulations and orders, which provide further detail and specificity regarding the application of the Act.
Key Provisions
Under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act), the Secretary of the Department of Health has granted consent to Bayer Australia Pty Ltd for the importation and supply of specific therapeutic goods that do not fully comply with the labelling requirements set out in the Therapeutic Goods Order No. 69 (section 14(1)(a)(i)). This consent is for a period from 12 December 2015 until 12 December 2016 (section 14A(2)). The consent applies to several products, including AERIUS desloratadine 5mg tablets, AERIUS FOR CHILDREN SYRUP, various DEMAZIN products, and DRIXINE products. These products will not include all the advisory statements required by the Medicines Advisory Statements Specification 2014, which came into effect on 12 December 2015.
The Act imposes several obligations on Bayer Australia Pty Ltd and other entities governed by it. Primarily, they must ensure that the labels of the specified products accurately reflect the consent granted by the Secretary of the Department of Health. This means that while the products may not comply with certain labelling requirements, they must still provide clear and appropriate information to consumers to ensure safe use. The consent also mandates that the labels must be those previously approved by the Therapeutic Goods Administration (TGA) for the former sponsor, Merck Sharp & Dohme (Australia). This ensures continuity and compliance with existing standards, except where specifically noted in the consent.
Failure to comply with the conditions of this consent, or any other provisions of the Therapeutic Goods Act 1989, may result in various civil and criminal consequences. Under section 27 of the Act, any person who contravenes the provisions of the Act or the regulations may be liable to penalties. Specifically, for corporations, the maximum penalty for each contravention is $210,000, while for individuals, the maximum penalty is $42,000. Additionally, under section 30A of the Act, a court may order the confiscation of goods that are the subject of an offence, or that were used in the commission of the offence. These penalties underscore the importance of adhering to the legislative requirements and conditions set out in the consent.