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TGA medicine labelling and packaging review
About this review
The requirements for medicine labels and packaging are specified in Therapeutic Goods Order 69 (TGO 69) General requirements for labels for medicines. This Therapeutic Goods Order has been in place since 2001. Since that time a number of consumer safety risks have been identified that may be avoided by improving the requirements specified in TGO 69. Some stakeholders have also indicated that the way information is presented on some medicine labels and packaging could be improved to make it easier for consumers to understand what is in their medicine and how it should be used and to decrease medication errors made by health professionals. It is therefore timely to conduct a review to assess whether the requirements specified in TGO 69 continue to be relevant to the objectives of the National Medicines Policy.
This review is primarily concerned with the presentation of the information on the medicine containers or on the boxes within which they are supplied. Of particular interest are the visual aspects that contribute to the usability of the information provided and facilitate the safe use of the medicine by health care professionals and consumers.
The key issues to be addressed by this review were determined through collation and analysis of previous consultations with key stakeholders on proposed updates to TGO 69. In preparing this paper the TGA also considered reports from consumer groups; industry feedback; and consultation with other key stakeholders. Further background to issues addressed in this review can be found in the Report on National Round Table on Safer Naming, Labelling and Packaging of Medicines.
The objective of the review of the requirements for medicine labels and packaging is to develop appropriate regulatory solutions that effectively address the consumer safety risks posed by the following issues:
- information about the active ingredient(s) contained in the medicine is not always easy to find
- use of the same brand name for a range of products with different active ingredients resulting in look-alike medicine branding (this is known as brand extension or trade name extension)
- medicine names that look-alike and sound-alike that can lead to use of the incorrect medicine
- medicine containers and packaging that looks like that of another medicine
- lack of a standardised format for information included on medicines labels and packaging
- dispensing stickers that cover up important information
- information provided on blister strips
- information included on small containers
- information provided in pack inserts
The following matters are outside of the scope of this review and, although the TGA may note any submissions received on these issues for future reference, they will not be considered as part of this review.
- Recommendations 6 and 7 of TGA reforms: A blueprint for TGA's future regarding information provided on the labels of listed medicines explaining that the efficacy of these products has not been evaluated by TGA. This issue is being addressed as a part of the reform of the complementary medicines regulatory framework that is currently underway.
- Whether the presence of nanoparticles in medicines should be declared on medicines labels.
- The details of medicine-specific information to be included on labels, for example specific indications or actual directions for the use of a specific medicine, with the exception of medicines containing paracetamol and ibuprofen.
- The Required Advisory Statements for Medicine Labels (RASML).
- Therapeutic Goods Order 80 Child Resistant Packaging for Medicines.
- Code of practice for tamper evident packaging.
- The Standard for the Uniform Scheduling of Medicines and Poisons (Poisons Standard), which specifies the level of access to medicines and poisons as well as the requirements for the pharmacist's dispensing sticker.
- Labelling of medical devices, biologicals and other therapeutic goods not regulated as medicines.
- Electronic access to medicine information, including pack inserts and consumer medicine information.
- The use of tall man lettering. For more information regarding the tall man lettering standard developed by the Australian Commission on Safety and Quality in Health Care, please refer to the National Standard for the Application of Tall Man Lettering.
- Matters covered by Industry Codes of Conduct, such as Patient Support Programs.