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Therapeutic Goods (Advertising Complaints and Investigations Information) Specification 2019
6Therapeutic goods information
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6 Therapeutic goods information
The kinds of therapeutic goods information set out in column 2 of the table in Schedule 2, as described in column 3 of the corresponding item, are specified for the purpose of subsection 61(5C) of the Act.
Note: Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).
Schedule 2—Specified kinds of therapeutic goods information
Note: See section 6.
| Kinds of therapeutic goods information |
|---|
| Column 1Item | Column 2Information | Column 3Description |
|---|---|---|
| 1 | responsible person | the name of the responsible person in relation to the advertisement or dissemination of generic information that is the subject of the case |
| 2 | therapeutic goods | the name of the therapeutic goods relating to the advertisement or dissemination of generic information that is the subject of the case (the relevant goods) and any other information necessary to identify the relevant goods |
| 3 | Register number | the device number, listing number or registration number of the relevant goods |
| 4 | reference number | the relevant reference number |
| 5 | case number | the relevant case number |
| 6 | risk category | the level of risk assigned to the relevant case by the Therapeutic Goods Administration |
| 7 | case details | the details of the case, including:(a) the alleged breach of the Act, Regulations or Therapeutic Goods Advertising Code;(b) the circumstances in which the relevant goods were advertised or the generic information was disseminated, such as means and location;(c) the complaint, or a summary of the complaint, or reason for the investigation commenced by the Therapeutic Goods Administration on its own initiative, relating to the advertisement or dissemination of generic information; and(d) where the complaint led to a recommendation being made to the Secretary under regulation 42ZCAI of the old Regulations:(i) a summary of, and website link to, the Complaints Resolution Panel’s determination and recommendation; and(ii) any identifying number assigned to the complaint by the Complaints Resolution Panel |