Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 15A

Conditions of registration of therapeutic goods

         (1)   For the purposes of paragraph 28 (5) (e) of the Act, a person to whom the registration of a therapeutic good specified in Part 1 of Schedule 10 relates must comply with the reporting requirements set out in the document entitled 'Australian Guideline For Pharmacovigilance Responsibilities Of Sponsors Of Registered Medicines Regulated By Drug Safety And Evaluation Branch' published by the Therapeutic Goods Administration, as in force from time to time.

         (2)   For the purposes of subregulation (1), a reference to a registered medicine or a registered medicinal product in the document mentioned in that subregulation is taken to be a reference to a therapeutic good.



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