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Regulatory impact statement (RIS) - update to the Required Advisory Statements for Medicine Labels (RASML)

May 2013

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2. Introduction

2.1 Background

Adverse events associated with medications are common, affecting a substantial number of people and placing a significant burden to health care costs. In Australia, approximately 2-3% (or 190,000) of annual Australian hospital admissions are medication related,i,ii with an estimated cost to the health care system of $380 million to $660 million. About half of these medication-related admissions are due to medication errors which are considered potentially preventable. Overseas studies report similar figures.iii,iv

All medicines have risks associated with their use. Some risks are general risks for all consumers, while other risks are specific to a set of consumers. For example, some medicines should not be taken by pregnant women, as there may be harmful effects on the foetus. Some medicines should not be taken by people with medical conditions such as heart disease, kidney disease or liver damage, or by people taking other medicines at the same time. There are also medicines that can cause side effects that all consumers should be aware of, such as drowsiness at normal doses, or serious side effects in overdose. The risks that a medicine may pose may be reduced by measures such as a smaller pack size and adequate directions on the label. Measures such as these can allow the medicine to be regulated under a lower regulatory framework (e.g. OTC rather than prescription) without compromising patient safety.

2.2 Current regulation of non-prescription medicines in Australia

As of 1 August 2012, there were 14,589 non-prescription medicines (sponsored by 992 companies) included on the Australian Register of Therapeutic Goods ('the ARTG'). Information published by the Australian Self Medication Industry Association (ASMI) indicates that the current value of the Australian non-prescription medicines market (grocery and pharmacy combined) is about $3 billion. Grocery stores (including supermarkets and healthfood stores) account for 26% of the market; pharmacies account for 74% of the market.

Non-prescription medicines supplied in Australia must be either listed or registered on the ARTG in accordance with the requirements of the Therapeutic Goods Act 1989 ('the Act') and the Therapeutic Goods Regulations 1990 ('the Regulations').

Under section 25 and section 26 of the Act, the TGA delegate of the Secretary must be satisfied that medicines that are proposed to be registered or listed on the ARTG satisfy a number of specific criteria, including:

  • acceptable quality and safety (and efficacy in the case of registered medicines)
  • presentation that is not unacceptable
  • compliance with applicable standards.

In addition to its own expert staff, the TGA currently has the following four statutory advisory committees from which it obtains independent expert advice on specific scientific and technical matters to aid the TGA's regulatory decision making.

  • The Advisory Committee on Complementary Medicines (ACCM) advises and makes recommendations to the TGA regarding the entry of complementary medicines on the Australian Register of Therapeutic Goods.
  • The Advisory Committee on Non-prescription Medicines (ACNM) advises and makes recommendations to the TGA regarding the entry of non-prescription medicines on the Australian Register of Therapeutic Goods.
  • The Advisory Committee on the Safety of Medicines (ACSOM) advises and makes recommendations to the TGA on the safety of medicines and risk assessment and risk management of medicines.
  • The Advisory Committee on medicines scheduling (ACMS) advises and makes recommendations regarding how medicines and chemicals will be made available to the public1.

Committee members are appointed by the Minister and must have expertise in relevant clinical or scientific fields or appropriate consumer issues. The advice provided by these committees is an important element in the undertaking by the TGA of its regulatory functions, and forms part of the information that is available to a TGA delegate making a regulatory decision under the Therapeutic Goods Act.

Once a medicine has been approved for supply in Australia, the TGA monitors its ongoing safety and quality by conducting a range of monitoring activities, such as audits of efficacy, manufacturing facilities, collection and assessment of adverse reaction reports and laboratory testing of product samples. The TGA also works with international medicines regulators to identify signals that may indicate a safety issue associated with a medicine.

Where such signals are detected, the TGA has the powers to take prompt and proportionate regulatory action to minimise risks. Such action could include requiring the addition of advisory statements to medicine labels, adding conditions to the continued supply of the medicine, or product recall, suspension or cancellation. The medicines industry is an active participant in this process (e.g. conduct their own monitoring of adverse events etc).

The regular review of medicine labels to reflect new or revised advisory statements is a long standing international industry practice that is conducted in cooperation with medicines regulators in Australia and overseas.

2.3 The importance of labels for non-prescription medicines

Non-prescription medicines can be purchased with minimal advice from health professionals. In particular, medicines available in grocery stores can be purchased with no advice. In the absence of professional health advice, consumers are vulnerable to any potential harm that could be caused by use of the medicines. For users of non-prescription medicines, the medicine label is therefore an important source of information about the medicine. In some cases, the label is the only source of information.

At the point of sale, the information provided on the label of non-prescription medicines must allow the consumer to quickly and easily make a choice about the suitability of the medicine (i.e. is it the right one for their needs). The label should also provide the consumer with information about important risks associated with use of the medicine. The risks may mean that some consumers should not use the medicine at all.

At the point of use, consumers should have access to instructions for using the medicine safely and effectively. This is particularly important for medicines that treat recurring minor ailments such as headaches, coughs and colds. Consumers may store such medicines at home to have available when and if needed, and any verbal advice that was provided when the medicine was purchased may well be forgotten when the medicine is used.

2.4 Current enforcement of mandatory advisory statements on medicine labels

Mandatory advisory statements for non-prescription medicines are currently compiled in the Required advisory statements for medicine labels ('the RASML'). The current RASML is published on the TGA website; and is not a legislative instrument.

The first version of the RASML (published on the TGA website on July 2004) was a compilation of the relevant requirements of the Regulations and the Schedule for the Uniform Scheduling of Drugs and Poisons (SUSDP)2. There have been three updates to the RASML since its initial publication. These updates incorporated the requirements of new 'Listing Notices'3, as well as recommendations of the National Drugs and Poisons Scheduling Committee (NDPSC) in regards to non-prescription analgesics ('pain-killers') and fluoride-containing medicines.

The current edition of the RASML (September 2008) is enforced under the Act through reference in the Therapeutic Goods Order No. 69C - Amendment to Therapeutic Goods Order No. 69 General requirements for labels for medicines ('the Labelling Order'), which is a standard under the Act.

Under the new sections 3(5)(ca) and 3(5A) of the Act, which came into force in 2009, the presentation of a medicine is unacceptable if the medicine's label does not contain advisory statements specified by the Minister by legislative instrument. In the Explanatory Memorandum to these new sections of the Act it was indicated that the RASML was intended to be the basis for this new instrument (the instrument does not yet exist).

However, even where an advisory statement is not included in the RASML, the TGA delegate of the Secretary can still take action under sections 25, 26 and/or 28 of the Act to enforce the advisory statement (or refuse to register or list the medicine), if the safety and/or presentation of the medicine are considered unacceptable without the statement.


  1. Medicines and chemicals are grouped into Schedules according to the appropriate level of regulatory control over their availability (e.g. Schedule 4 - medicines available only by prescription; Schedule 3 - medicines available only from a pharmacist; Schedule 2 - medicines available over the counter in pharmacies).
  2. The SUSDP has subsequently been renamed the Schedule for Uniform Scheduling of Medicines and Poisons, and enabled as the Poisons Standard.
  3. See explanation of Listing Notices in Appendix 1.

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