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ARGOM: Guidelines on changes to OTC medicines
V1.1, April 2013
Does the change make the therapeutic goods 'separate and distinct'?
Some changes may render the changed therapeutic goods separate and distinct from the present goods. Section 16 of the Act lists those criteria which make goods separate and distinct.
Where the Therapeutic Goods (Groups) Order (the 'Groups Order') applies, the sponsor of an OTC medicine can replace the existing product in the ARTG with a new OTC medicine. An example of this is when a sponsor changes the name of an existing OTC medicine in the ARTG. For a summary of the provisions of the Therapeutic Goods (Groups) Order, refer to the Groups Order - summary.
However, if a new OTC medicine is separate and distinct from the existing medicine and the Groups Order does not apply, the sponsor will need to submit a new application for registration of the medicine.
Applications to register separate and distinct OTC medicines (regardless of whether the Groups Order applies or not) do so under the provisions of Section 23 of the Act.