Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 16AA

Information or documents that Secretary may require

Information or documents relating to registered goods

  (1)   For paragraph   31(1)(k) of the Act, the following matters are prescribed:

  (a)   matters relating to the scheme provided in Subdivision   2 of Division   1 of Part   7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;

  (b)   matters relating to an application to the Secretary under regulation   43AAH to waive the annual registration charge in respect of the goods for a financial year.

Information or documents relating to listed goods

  (2)   For paragraph   31(2)(h) of the Act, the following matters are prescribed:

  (a)   the efficacy of the goods for the purposes for which the goods are to be used;

  (b)   matters relating to the scheme provided in Subdivision   2 of Division   1 of Part   7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;

  (c)   matters relating to an application to the Secretary under regulation   43AAH to waive the annual listing charge in respect of the goods for a financial year.

Information or documents relating to biologicals

  (3)   For paragraph   32JA(1)(p) of the Act, the following matters are prescribed:

  (a)   matters relating to the scheme provided in Subdivision   2 of Division   1 of Part   7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;

  (b)   matters relating to an application to the Secretary under regulation   43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.


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