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Monday, May 8, 2017

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.
medicine pack with active ingredient in larger font

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 pack with new critical information panel

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

Medicine pack with allergin information highlighted
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.


Medicine pack with space for dispensing label

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.
 




www.gmpviolations.com GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.
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