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Changes to ingredient names: End of transition period - are you ready?
The transition period for updating medicine ingredient names ends on 30 April 2020.
This means that from 1 May 2020 all medicines released for supply in Australia must use the new ingredient names.
The four year transition period has provided sufficient time for sponsors to move over to using the new names. With less than 12 months left, consumers and health professionals are expecting to see the new ingredient names on medicine labels and relevant documentation.
We want to help sponsors meet their regulatory obligations. That's why in 2016 we wrote to all affected sponsors with details of the medicines that were affected by the name changes.
Below is a useful checklist of things to think about when checking to see if your medicines' documentation needs to be updated.
- Do you have a medicine that contains an ingredient on the affected ingredients list
- If the ingredient is used as an active ingredient, is the right ingredient name displayed on your medicine labels?
- If the ingredient is used as an excipient and you include the names of excipients on your labels, is the right ingredient name displayed?
- If the medicine has an associated product information or consumer medicine information document, is the right ingredient name used in those documents?
- If you have advertising materials for your medicine that include ingredient names, is the right ingredient name used in those materials?
Update your labels and other materials
Sponsors need to make sure that all relevant documentation is being updated and to minimise stock that still use old ingredient names. This will help to reduce confusion for consumers as we approach the end of the transition period.
Generic sponsors can update ingredient names in their medicines documentation without waiting for the innovator to change their products.
Further information on the process for updating your documentation is available at information for sponsors.
Don't let 1 May 2020 sneak up on you - make your changes as soon as possible.