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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