I, ROHAN HAMMETT, a delegate of the Minister for Health and Ageing, make this Specification under subsection 61 (5D) of the Therapeutic Goods Act 1989.

Dated 5 November 2009

ROHAN HAMMETT

Delegate of the Minister for Health and Ageing

1 Name of Specification

  This Specification is the Therapeutic Goods Information Specification 2009.

2 Commencement

  This Specification commences on the day after it is registered.

3 Definitions

  In this Specification:

Act means the Therapeutic Goods Act 1989.

register means the Australian Register of Therapeutic Goods.

Regulations means the Therapeutic Goods Regulations 1990.

4 Therapeutic goods information

  For subsection 61 (5D) of the Act, therapeutic goods information of the kinds mentioned in Schedule 1 is specified.

Schedule 1 Kinds of information

(section 4)

 1 Product information, within the meaning of subsection 9D (5) of the Act:

 (a) included in the notification to an applicant under subsection 25 (4) of the Act of the decision of the Secretary to register the goods; or

 (b) approved as a condition of registration under section 28 of the Act; or

 (c) varied by the Secretary under section 9D of the Act.

 2 Written information required by regulation 9A or 9B of the Regulations.

 3 Documents prepared by the Secretary for the purpose of evaluating the quality, safety and efficacy of a therapeutic good under paragraph 25 (1) (d) of the Act.

 4 Summary of the post-market pharmacovigilance requirements imposed as a condition under subsection 28 (1) of the Act or by regulation 15A of the Regulations for a registered medicine under section 25 of the Act.

 5 Documents relating to assessments made as part of evaluation of the pharmacovigilance system, quality and non-clinical and clinical data of a therapeutic good under section 25 of the Act.

 6 Documents included in the request of the Secretary of the Australian Drug Evaluation Committee seeking advice in relation to:

 (a) the evaluation of a therapeutic good for section 25 of the Act; or

 (b) the evaluation of a therapeutic good mentioned in Part 1 of Schedule 10 to the Regulations.

 7 The Australian Drug Evaluation Committee’s advice about the evaluation of a therapeutic good for section 25 of the Act.

 8 Minutes, or excerpts of minutes, of meetings of the following:

 (a) Australian Drug Evaluation Committee established under regulation 36 of the Regulations;

 (b) Pharmaceutical Subcommittee of the Australian Drug Evaluation Committee;

 (c) Adverse Drug Reactions Advisory Committee, a subcommittee of the Australian Drug Evaluation Committee;

 (d) Advisory Committee on the Safety of Medicines.

 9 Resolutions or recommendations, or parts of those resolutions or recommendations, of expert committees established by the Regulations, about the suitability for inclusion in the register of therapeutic goods the subject of an application for registration on the register.

 10 Written decisions or excerpts of written decisions, or details of decisions, of the Secretary under section 25 of the Act, including the reasons for the decisions.

 11 Details of the cancellation of registration or listing of a therapeutic good.

1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.