Australia's medicine labels are becoming clearer

When you buy prescription and over-the-counter medicines, sunscreens or vitamin supplements, you need important information to help you make an informed choice.

Medicine labels tell you what you are buying, what the medicine can do for you and how to use it.

What?

Why?

When?

Your labels?

 

What is changing under the new labelling rules?

We are changing medicine labels to make important information about your medicine easier to find. These changes are the result of many years of consultation - they bring Australian medicine labels up to date with international best practice.

Active ingredients will be easier to find

The active ingredient is the substance in the medicine that makes it work.
You probably know of paracetamol, ibuprofen or insulin - all of these substances are active ingredients. Under the new labelling rules active ingredients need to be more prominent. You will usually be able to find them below or next to the product name on the front of the medicine pack. Active ingredients will often be in a larger print size on the front label to make them easier to read.
Make sure to look for the active ingredients on your medicine labels so you know what you are taking.

Medicine information will be clearer

Most over the counter medicines will have critical health information in distinctive tables to help you use your medicine safely. Over the counter medicines are medicines that you buy without a prescription.
The new rules mean that critical health information will always be displayed in a consistent order and will be easy to recognise.
Always check the critical health information before you take your medicine.

More information on the label

Under the new rules more substances that could cause an allergic reaction will need to be included on labels. These substances include crustacea, fish, eggs, soya, milk and tree nuts.
For non-prescription medicines this information will be on the label. For prescription medicines this information must appear on the label or in the Consumer Medicine Information leaflet with a prompt on the pack.

More room for important information

The new rules include a minimum space for dispensing labels. These are the labels that pharmacists stick on prescription medicines with information from your doctor.
This space makes it easier for the pharmacist to attach the dispensing label without covering up other important information.

Why are medicine labels changing?

Labelling requirements for Australian medicines are being updated after many years of consultation with industry, health professionals and the community. The changes help bring Australian medicine labels up to date and align them with international best practice. They will help Australians to make more informed choices about their medicines and use them more safely.

When are labels changing?

The new labelling rules took effect from 31 August 2016. There is a four year transition period to allow medicine manufacturers time to update their labels and to sell their existing stock. This means that after 31 August 2016 you may start seeing updated medicine labels, but you could still see older labels as well. During the transition period both versions are acceptable - manufacturers need to meet either the old or the new rules.

From 1 September 2020 all medicine labels will need to meet the new rules.

What other information is on my label?

Labels have all sorts of useful information on them. Next time you look at a medicine keep an eye out for:

AUST R and AUST L numbers

Medicines sold in Australia will have either an AUST R or an AUST L number (but not both).

AUST R numbers

AUST R medicines (also known as registered medicines) are assessed for quality, safety and effectiveness before they can be sold. They include all prescription-only medicines and many over-the-counter medicines.

An AUST R number means the medicine is more tightly controlled and regulated.

AUST L numbers

AUST L medicines (also known as listed medicines) are lower risk self-medication products. They are used for minor health problems and are less regulated than AUST R.

Listed medicines include fish oils, multivitamins and herbal and homoeopathic products.

 

Storage conditions

Labels have to tell you how to store a product - some medicines lose their effectiveness if not stored correctly.

Expiry date

This is similar to the use-by date on food. Medicines should never be used after their use-by date - they can lose their effectiveness or even become unsafe.

Batch number and company address

The batch number and name and address of the supplier can be used to trace a medicine if a problem is found.

 

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TGA Alerts on Sanoma Garden - various therapeutic goods

TGA Alerts on Sanoma Garden - various therapeutic goods

Consumer alert

Consumers are advised not to purchase medicines or medical devices being offered by Sanoma Garden.

Material from Sanoma Garden may create the impression that they have Australian-based operations, with a local post office box address and phone number, however, this is not the case.

Consumers should be aware that therapeutic goods purchased via Sanoma Garden:

are not subject to Australia’s stringent requirements for quality, safety or efficacy (effectiveness), and

are unlikely to deliver on the claims of efficacy that are set out in the promotional material.

In addition, consumers should be aware that purchases made via Sanoma Garden:

are unlikely to be protected by Australian Consumer Law(link is external) or other fair trading laws, and

may result in personal details, including credit card information, being sent to unknown overseas entities.

Products supplied by mail order from overseas are not regulated by the TGA. If care is not taken, consumers may inadvertently risk their health and waste their money.

Sanoma Garden may also promote health products as foods.

Information for consumers

If you, or someone you care for, have purchased medicines or medical devices from Sanoma Garden, the TGA recommends that you stop using them and take any remaining product to a pharmacy for safe disposal(link is external)

Examples of products being sold by Sanoma Garden include 'Algicaps', ‘Double shot weight loss pills’, foot patches for detoxification and ionic bracelets for pain relief. Many of these products are being promoted for the treatment of serious conditions that require diagnosis and treatment by a health professional, such as cardiovascular disease, osteoarthritis, osteoporosis, diabetes and high cholesterol. If you suspect that you, or someone you care for, has a serious condition, a health professional should be consulted.

Information for health professionals

If you are treating a patient who is using a product supplied by Sanoma Garden, advise them to discontinue use and take any remaining product to a pharmacy for safe disposal(link is external).

Additional information

As the source, quality and safety of the goods from Sanoma Garden cannot be verified, the TGA advises consumers they should not purchase therapeutic goods sold by this company and to exercise general caution if purchasing therapeutic goods advertised via direct mail or the internet.

Consumers should be particularly vigilant if the advertising refers to:

emotive and sensational phrases with exclamation marks, such as ‘miracle cure' and 'scientifically proven breakthrough',

'testimonials' from cured customers or medical experts,

claims that the product can cure or treat serious or incurable diseases,

greatly reduced/discounted prices, but which may still be of high dollar value, and

offers of money back or other guarantees and other incentives (such as free gifts or free trials).

See Buying medicines and medical devices online for more information.

Reporting problems

If you have encountered promotional material or products that you are concerned about, you can Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products.

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Warning about weight loss products on the web by TGA

30 August 2016

Australia's medicines regulator, the Therapeutic Goods Administration (TGA) has warned of the dangers of buying weight loss medicines online, particularly from unknown overseas websites.

The TGA's Principal Medical Adviser, A/Professor Tim Greenaway, said today the TGA had received many reports about overseas based websites offering 'herbal' or 'drug free' weight loss products.

"Far from being 'natural', many of these products contain ingredients which may be harmful and are not disclosed on the product label," Professor Greenaway said.

"In Australia, many weight loss products are considered medicines. Because of this they are regulated by the TGA and have to meet quality and safety standards but we have no control over medicines and supplements purchased from overseas by consumers on the web."

"Not only have many of these products not been evaluated for safety by the TGA, some are not approved for supply in Australia."

Dr Greenaway said it is most concerning that analysis of seized products by the TGA Laboratories has found products that contain contaminants such as undisclosed pharmaceutical substances, including:

• Sibutramine - a prescription-only substance in Australia. Sibutramine was withdrawn from world markets in 2010 due to increased risk of cardiac events (like heart attack) and stroke.
• Phenolphthalein - was withdrawn from sale on many markets in the late 1990's due to concerns over increased risk of cancer with long term use.

"Both Sibutramine and Phenolphthalein can cause dangerous interactions with other medications which could have serious consequences for your health," Professor Greenaway said.

"We strongly urge Australians to use extreme caution when considering buying weight loss medicines online from unknown websites."

"People should also be suspicious of wild claims. If a website or product seems too good to be true, it probably is. Make sure you're buying from a legitimate Australian pharmacy."

Professor Greenaway said if anyone is concerned about products they may have taken they should consult their pharmacist or GP.

More information is available on the TGA website, including details of where to lodge a complaint, at:Buyer beware when considering weight loss products from overseas websites

Source: TGA

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