Updating medicine ingredient names - information for sponsors
The transition period for the harmonisation of medicine ingredient names began on 6 April 2016.
The Australian Approved Names list has been updated with new ingredient names. Formulation details of all affected Australia Register of Therapeutic Goods (ARTG) entries have also been updated with the new ingredient names.
Transition period - what sponsors need to do
Sponsors have four years to update their labels and product information (PI) documents with the new ingredient names. These changes do not need to be made at the next subsequent variation to a product.
Major variations to existing medicines that create a separate and distinct good are treated as new products. In these circumstances the new ingredient names must be used on labels and within product information documents.
All new products registered or listed onto the ARTG must now use the new ingredient names on labels and within product information documents. This includes new registrations or listings that are created by variations to existing medicines.
Where a change is needed to a label or PI document, sponsors must submit to TGA a copy of the updated label and PI document for approval. This can be as part of other changes to their labels/PIs or as a separate variation.
For variations to prescription medicines, please note in your variation application that the ingredient name change is due to harmonisation.
For OTC and Registered complementary medicines, use the change code 'IHN' (category 'Other') in TGA Business Services for the ingredient name changes.
Where a change is needed to a label on a listed medicine, sponsors do not need to provide these to the TGA.
Some generic medicine trade names include the old active ingredient name. These names have not been changed within ARTG entries as the trade name of a medicine is owned by the sponsor company.
Sponsors of these medicines can voluntarily update their trade name to the new ingredient name.
This change to a trade name would not be subject to a fee if requested during the transition period.