Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 43AAB

Definitions

         (1)   In this Subdivision:

"approved person" means a person who is a qualified accountant under section 88B of the Corporations Act 2001 , but does not include:

                (a)    a person who, under this Subdivision, is required to submit to the Secretary a statement signed by an approved person; or

               (b)    an employee of that person.

"existing entry" , for a therapeutic good, means an entry for registration, listing or inclusion of the therapeutic good in the Register that is not a new entry.

"low value turnover" means a turnover of not more than 15 times the annual registration charge, the annual listing charge or the annual charge for inclusion in the Register payable for a financial year.

"new entry , " for a therapeutic good, means an entry for registration, listing or inclusion of the therapeutic good in the Register that commenced in the financial year.

"turnover" , for a therapeutic good, means gross dollar receipts (excluding GST) from sales of the therapeutic good in Australia for a financial year, including retail and wholesale sales.



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