Kids Health Info

Medicines for children - about

  • In Australia most, but not all, medicines are registered. This factsheet explains why medicines are registered, and why some medicines that are of benefit to children are not registered for children.

    Why are medicines registered?

    The Therapeutic Goods Administration (TGA) is a federal government agency which is responsible for ensuring medicines available in Australia are safe and are of an acceptable standard.

    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 the medicine has been included on the ARTG.

    An AUST R number means the medicine has been shown to work for particular illnesses.  It 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 a clinical trial. Information gained 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 specific 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.
    • 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
    • it may be too expensive to test or produce some medicines for children
    • it may be too expensive to register a product in Australia that is available overseas.

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

    You will know if your child's medicine is not registered if the information leaflet provided with the medicine does not refer to your child's condition or particular illness. It may also say the medicine should not be used for children under a certain age.

    Medicines which are not registered may be harder to get. Some of these products are only available from the pharmacy at The Royal Children's Hospital (or from other hospital pharmacy departments).

    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 the medicines are registered or not.

    If you still have concerns after reading this factsheet, 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 a certain medicine. They will be able to tell you what side effects your child can expect and the 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, or refer to the RCH Support Group Directory.

    For more information on medicines contact:

    • Drug Information Centre
      The Royal Children's Hospital
      Phone: (03) 9345 5208
    • 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 October 2010

How did you like this fact sheet?
Click here to do a short RCH survey.

Kids Health Info app

The app will enable you to search and browse more than three hundred medical fact sheets and work offline.

Apple store Google play

This information is intended to support, not replace, discussion with your doctor or healthcare professionals. The authors of these consumer health information handouts have made a considerable effort to ensure the information is accurate, up to date and easy to understand. The Royal Children's Hospital, Melbourne accepts no responsibility for any inaccuracies, information perceived as misleading, or the success of any treatment regimen detailed in these handouts. Information contained in the handouts is updated regularly and therefore you should always check you are referring to the most recent version of the handout. The onus is on you, the user, to ensure that you have downloaded the most up-to-date version of a consumer health information handout.