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Section 16(1) and (1A) of the Therapeutic Goods Act 1989 list the differences that result in goods being considered separate and distinct from other goods.
Some therapeutic goods are considered to be in a 'gazetted therapeutic goods group'. Gazetted therapeutic goods groups are determined by orders published in the Gazette.
However, individual products within the group remain separate and distinct products under section 16(1) and (1A).
- Therapeutic Goods (Groups) Order No. 1 of 2001
Therapeutic goods order in relation to variation in excipients (or non-active ingredients) used in medicines - Therapeutic Goods (Groups) Order No. 1 of 1992
The majority of this Order has been revoked by Therapeutic Goods (Groups) Order No. 1 of 2001. However, Section 11 of this Order, which includes amendments to Clause 4 of Therapeutic Goods (Single Therapeutic Goods) Order No. 1 of 1991, remains effective.
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