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Medicines for children - about

In Australia most medicines are ‘registered' but some are not. This factsheet explains why medicines are ‘registered' and why some useful medicines are not registered for children.

Why are medicines "registered"?

The Therapeutic Goods Administration (TGA) is the part of the Australian Government responsible for ensuring that medicines available in Australia are of an acceptable standard and safe.

Most medicines must be included on the Australian Register of Therapeutic Goods (ARTG). An AUST R or AUST L registration number on a label shows that the medicine has been included on the ARTG.

An AUST R number shows that the medicine has been shown to work for particular illnesses, has been assessed for side effects or risks and has been made to a high standard.

AUST L numbers are given to lower risk products used for minor health complaints or health maintenance. They do not have to undergo the same tests.

How are medicines tested?

To be sure that a medicine works and is safe, it is tested first on a small number of people in what is called a ‘clinical trial'. Information from clinical trials is given to the TGA before the medicine is given an AUST R number.

Why aren't all medicines registered for use in children?

Some medicines are used for illnesses, age groups or conditions not covered in the original application for an AUST R number.

Some reasons for this include:

  • the clinical trials (and product registration) may be for one illness but later it is found that the medicine works well for another illness; or
  • clinical trials may have been in adults but the medicine has been found to work well in children also.

Some medicines are not registered in Australia at all. Examples of these are some liquid medicines for children or medicines used for rare illnesses. These may not be registered because there may not be enough children with the illness to have a clinical trial. Sometimes it may be too expensive to test and produce some medicines for children, or to register a product in Australia that is available overseas.

How will I know that my child's medicine is not registered?

When you read the information leaflet provided with the medicine you might notice that the information does not refer to children. It may not mention your child's particular illness or condition or it may say that the medicine should not be used for children under a certain age.

Medicines which are not registered may be more difficult to obtain. Some of these products are only available from the pharmacy at the Royal Children's Hospital (or other hospitals).

How do I know that such medicines are safe and will work?

Doctors and pharmacists caring for children have a lot of experience with medicines used for children, whether they are registered or not. If you still have concerns after reading this leaflet, please talk to your child's doctor or pharmacist. They have thought carefully about the best medicine for your child. They can also tell you about other available treatments and why they have recommended the medicine. They will be able to give you information on side effects to expect or watch out for and likely benefits or changes the medicine should make to your child's health.

Where can I get more information?

  • Your pharmacist may have made a special information leaflet about the medicine. Please ask.
  • There are often special support groups for children with particular illnesses or conditions. Please ask your doctor, pharmacist or nurse for more information.

For more information on medicines you may contact:

This leaflet has been adapted from information produced by the UK Joint Royal College of Paediatrics and Child Health/Neonatal and Paediatric Pharmacists Group Standing Committee on Medicines.

Developed by the RCH Pharmacy Drug Information Centre.  First published 2005.  Updated June 2008

 

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