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TGA medicine labelling and packaging review


24 May 2012

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Appendix 4: Questions & answers about the labelling and packaging review

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The provision of good quality information presented on the labelling and packaging of medicines is intended to provide advice to patients and consumers on how to take their medicine safely and effectively.

This overarching principle applies whether the product is purchased from a supermarket or a pharmacy without a prescription, or following a consultation with a doctor and the pharmacist at the point of dispensing.

The TGA is aware that aspects of the current labelling and packaging requirements need to be reviewed in the context of promoting the safe and effective use of medicines. This review is being conducted in order to address issues and make recommendations on how medicine labels and packages can be presented in a way that is easy to understand by all consumers.

The key objective of this review is to develop changes for medicine labels to improve consumer safety when using medicines. Examples of consumer safety risks associated with medicines include accidental overdose, taking incorrect medicines for an illness or giving an incorrect medicine to a family member. Changes to medicine labels will also help consumers make informed choices about their medicines.

The active ingredient is the ingredient of the medicine that provides the health benefit to the consumer. It is common for medicines that contain the same active ingredient to be marketed by different companies. As a result, consumers have access to medicines with different labels, packaging and trade names, but with the same active ingredient.

Knowing the active ingredients of a medicine helps consumers:

  • to recognise when two different brands include the same active ingredient
  • to identify the differences between different medicines
  • to identify any ingredients that may cause allergic reactions, or interactions with other medicines
  • to identify suitable alternatives to well tolerated medicines when travelling overseas and Australian brands are not available
  • avoid accidental overdose.

Look-alike medicine branding can occur when two or more products are marketed under the same brand name. This may include products for treating a range of illnesses, usually of a similar type, being marketed under a single brand name, for example products for different types of coughs. This type of branding is also known as brand extension, or trade name extension.

Marketing in this way helps create brand recognition, trust and loyalty amongst medicine users, however it may also lead to confusion about the medicines which can compromise safety.

Look-alike medicine branding may result from extending an existing brand name to include a product that has been reformulated to include an active ingredient that was not previously included in the brand product range. Consumers who take the medicine based on the brand name without checking the active ingredients may suffer from adverse reactions to the newly formulated medicine. Another health risk to consumers arises when they inadvertently take more than one medicine with the same active ingredient, which may lead to an accidental overdose.

Look-alike, sound-alike (LASA) names are medicine names that look or sound the same as other medicine names when written or spoken. Look-alike medicine packaging refers to medicine containers or primary packaging that looks like that of another medicine, or that looks like a toy or a food.

Key risks to consumers from LASA medicine names result when they are accidentally given the wrong medicine by a pharmacist or health care professional or they select the wrong medicine themselves due to the similarity of the name or packaging of a medicine.

Look-alike medicine packaging also poses a risk to consumers from being provided a medicine that they were not prescribed by their health care practitioner. In the case where the medicine container or primary packaging looks like a toy or a food, as may be the case with some inhalers, there is a risk that children may be inadvertently exposed to the medicine.

A medicine information box is a standardised format for the information required on the labels of over-the-counter and complementary medicines. It is based on the "Drug Facts" box used by the US FDA to convey this information on over-the-counter medicines.

Information is presented in the same format and consistent location on primary packaging and medicine containers to help consumers find the information they need to make informed decisions about their medicines.

When a dispensing label is attached to this packaging, it is possible that important information is covered by the dispensing label, such as dosage instructions, instructions for appropriate storage or additional warnings. Without access to this information, there is a risk that the consumer may not use the medicine appropriately, which may result in an adverse event or the desired health benefit not being achieved.

The trade name of the medicine, the active ingredient and amount of active ingredient, batch number and expiry date must be repeated at least once every two units or each detachable segment of a blister strip.

The TGA is proposing changes to the labels of containers less than 20 mL in size to improve the access to necessary information. The amount of information on the label of the container has been reviewed and requirements for primary packaging are being considered.

Advertising material should not be included as a separate pack insert or incorporated into an approved pack insert. And, a pack insert must be in a form separate to the packaging; i.e. it cannot be printed on the inside of a carton.

The review has focused primarily on the presentation of information on the label of medicines, with particular focus on the visual aspects that contribute to the usability of the information provided and facilitate the safe use of a medicine by consumers. Addressing the identified consumer safety issues with the proposed regulatory changes will allow improvements to be made to medicine labels in the near future. It is expected that matters regarding the content of the medicine label will be addressed over time.

These issues were determined through collation of previous consultations conducted by the TGA on labelling requirements together with feedback and reports from consumer groups, industry and consultation with key stakeholders. The proposed changes were developed in conjunction with an external reference group representing consumers, health care professionals and industry.

The TGA is interested in the views of all stakeholder groups—consumers, industry and health care professionals—on the proposed regulatory changes. Details of the proposed regulatory changes can be found at TGA medicine labelling and packaging review. Alternatively, a hardcopy of the consultation can be arranged by phoning 1800 020 653.

For each of the issues, the TGA is seeking feedback for the proposed regulatory changes. Interested stakeholders are encouraged to provide a response to the general questions at the end of each section relating to the proposed regulatory changes. Stakeholders may respond to as many or as few of the questions as they wish.

Submissions to the general questions and industry specific information should be lodged electronically to Or if hardcopy is preferred please mail your submissions to TGA Labelling and Packaging Review, PO Box 100, Woden, ACT, 2606.

The closing date for submissions is close of business 24 August 2012.

Submissions will be published on the TGA website throughout the consultation period. At the close of the consultation period, the TGA will collate and analyse submissions on matters that are within the scope of this review. Any submissions related to other matters will be archived and may be considered at some point in the future. The TGA will make any refinements or amendments of the proposed regulatory options as appropriate.

These should be submitted to, or if hardcopy is preferred please mail your submissions to TGA Labelling and Packaging Review, PO Box 100, Woden, ACT, 2606. If they are within the scope of the review, they will be analysed and may be used to further refine and amend the proposed regulatory changes. Any submissions related to other matters will be referred on where relevant or noted and may be considered at some point in the future.

It is anticipated that the revised Therapeutic Goods Order for medicine labelling will be registered as a legislative instrument in mid-2013. This timeframe allows for the required consultation on the economic impact and the Therapeutic Goods Order to occur. From the time the new TGO is registered as a legislative instrument there will be a transition period, at this stage proposed to be three years. New medicines that are approved once the new requirements come into force will be required to comply immediately.

When considering the labelling of therapeutic goods (including sunscreens regulated by the TGA), the Australian Government aims to ensure that information provided is based on medical and scientific evidence. The reason for providing information on therapeutic goods labels is to support the consumer in the appropriate and safe use of the therapeutic good. To date, the TGA has not identified any evidence that supports changing requirements to include information about particle sizes. There is currently no evidence to suggest that sunscreen products which incorporate nanotechnologies pose greater safety risks than conventional products.

This review is focused on addressing issues related to consumer safety associated with the presentation of medicines information. Addressing these issues is a priority for improving consumer safety and can be achieved in a timely manner. It is envisaged that specific information included on labels will be reviewed separately when required.

Child resistant packaging requirements are addressed in Therapeutic Goods Order 80, which will be subject to a separate review process in due course.

Tall man lettering is outside of the scope of this review because it would be of most benefit to health care professionals and in a medicines dispensing setting; not as a direct solution for consumers.

Recommendations 6 and 7 of TGA reforms: A blueprint for TGA's future (information provided on the labels of listed medicines explaining that the efficacy of these products has not been evaluated by TGA) are being addressed as part of the reform of the complementary medicines regulatory framework that is currently underway.

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