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ARGOM: Guidelines on changes to OTC medicines
V1.1, April 2013
Groups Order - summary
The 'Groups Order' specifies the circumstances in which a 'separate and distinct' therapeutic good can be 'grouped' in the same ARTG entry (i.e. under the same AUST R number). In this case, a new OTC medicine can replace the existing product in the ARTG. The Groups Order explains when this is acceptable.
Section 16 of the Act sets out the criteria which make goods 'separate and distinct'. These are:
- a different name or
- different indications or
- different directions for use or
- a different type of container or
- a different dosage form or
- a different formulation or composition or
- a different strength or size (disregarding pack size).
When the Groups Order does not apply, the changed goods must have a separate ARTG entry and bear a separate AUST R number. If this is the case, the sponsor should apply for registration of the changed goods as if it were an entirely new product.
The provisions of the Groups Order (as applied to non-prescription medicines) may be summarised as follows.
Goods may be grouped when the only difference between the new goods and the existing goods is the proprietary name and when the new goods are to replace the existing goods in use.
Change in the amount of an excipient
Goods may be grouped when the formulation of the new goods is to be changed only by increasing or decreasing the amount of an excipient (but not adding or deleting an excipient) and when the new goods are to replace the existing goods in use.
Removal or addition of a fragrance, flavour, printing ink or colour
Goods may be grouped when the formulation is changed only by the addition or removal of a fragrance, flavour, printing ink or colouring agent and when the new goods are to be registered in place of the existing goods.
Revised indications and/or directions for use
Goods may be grouped when only the indications and/or directions for use are changed and the new goods are to be registered in place of the existing goods.