4Conditions of inclusion in Register—reporting and record-keeping

4 Conditions of inclusion in Register—reporting and record-keeping

For the purposes of paragraphs 32EC(2)(c) and (ca) of the Act, a person in relation to whom a biological is included in the Register must: (a) in relation to each distribution of the biologicals—keep a record of the distribution at least until the end of the period of 10 years after the distribution; and (b) comply with the record-keeping requirements and the reporting requirements set out in the document titled Biovigilance Responsibilities of Sponsors of Biologicals – Australian requirements and recommendations, version 1.0, published by the Therapeutic Goods Administration in December 2017.

Note: A copy of the document mentioned in paragraph 4(b) is available on the Therapeutic Goods Administration website (www.tga.gov.au).