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
Existing products
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.
New products
All new products listed onto the ARTG must now use the new ingredient names on labels and within product information documents. This includes new listings that are created by variations to existing medicines.
Listed medicines
Where a change is needed to a label on a listed medicine, sponsors do not need to provide these to the TGA.
The list of affected ingredients can be found here
