Cosmetic Compliance
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Standard for labels of non-prescription medicines
Local Title:
/
Country/Region:
Australia
Competent Authority:
Therapeutic Goods Administration
Type:
Regulation
Status:
In force
Release Date:
2016-08-02
Implementation Date:
2016-08-02
Document
Language Source Title Access
EN
Official therapeutic_goods_order_no._92_-_standard_for_labels_of_non-prescription_medicines.pdf
Summary

(1)     This Order sets out what kinds of information are required to be included on the label of medicines of the kind described in section 3, and in what circumstances.
(2)     The purpose of the label on a medicine is to provide information about the medicine such as its identity, potency, content, storage, expiry date, dose, directions for use, sponsor details and registration/listing status.  Labels on medicines can also include other information not required by this Order but which may be required by other legislation or for commercial purposes such as the sponsor’s logo.
(3)     The information included on a label contributes to the quality use of medicines.  Quality use of medicines means selecting management options wisely, choosing suitable medicines if a medicine is considered necessary, and using those medicines safely and effectively.
(4)     The requirements set out in this Order are consistent with the National Medicines Policy which aims to meet medication and related service needs, so that both optimal health outcomes and economic objectives are achieved. The four central objectives of the policy are:
·timely access to the medicines that Australians need, at a cost individuals and the community can afford;
·medicines meeting appropriate standards of quality, safety and efficacy;
·quality use of medicines; and
·maintaining a responsible and viable medicines industry.
(5)     This Order also sets out general requirements for the labels of non-prescription medicines.  The purpose of the Order is to facilitate the quality use of those medicines by consumers and health professionals by ensuring appropriate labelling. Consideration of the following objectives in designing labels, and assessing and determining compliance with the requirements of this Order, will assist in achieving that purpose:
·minimising the risk of prescribing, dispensing and self-selection errors;
·enhancing consumer safety;
·avoiding consumer confusion and the inappropriate use of medicines (including misuse, over-use, and under-use);
·assisting the appropriate selection of those medicines;
·assisting the safe and effective use of those medicines;
·optimising identification and usability of necessary information;
·improving consumers’ ability to solve problems related to those medicines, such as managing multiple medicines; and
·where relevant, ensuring consumers are aware of where to go for further information about their medicine.
(6)     Guidelines to assist in the design of medicine labels are available on the Therapeutic Goods Administration website (http://www.tga.gov.au).
(7)     Under the Act:
·whether a medicine conforms to a standard applicable to the medicine is a matter the Secretary must take into account in deciding whether to include the medicine in the part of the Register for registered goods
·an applicant for the listing of a medicine must certify that the medicine conforms to every standard applicable to the medicine
·failure to conform to a standard applicable to a medicine is grounds for the Secretary to suspend or cancel the registration or listing of the medicine
·failure to conform to a standard applicable to a medicine is grounds for the Secretary to require public notification and recovery of the medicine
·it is an offence to supply medicines in Australia that do not comply with a standard applicable to the medicine relating to labelling or packaging and civil penalties may be payable in relation to such supply
·whether the presentation of a medicine is acceptable is a matter the Secretary must take into account in deciding whether a medicine can be registered – ‘presentation’ means the way in which the medicine is presented for supply and includes matters relating to the labelling and packaging of the medicine.Subject to specified notice requirements, the Secretary may decide to suspend or cancel the registration of a medicine, if it appears to the Secretary that the presentation of the medicine is not acceptable
·an applicant for the listing of a medicine must certify that the presentation of the medicine is not unacceptable. Unacceptable presentation is a ground for suspension or cancellation of the listing of a medicine
·there are also grounds for the Secretary to require public notification and recovery of supplied medicines if:
o   in the  case of registered medicines, it appears to the Secretary that the presentation of the medicine is not acceptable; and
o   in the case of listed medicines, it appears to the Secretary that the presentation of the medicine is unacceptable.
(8)     To avoid doubt, this section is not part of the Order.