Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 15A

Conditions of registration and listing of medicines

    For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record - keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors , as in force from time to time.


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