Document ID: chunk:federal_register_of_legislation:F2017L00638:body:0:p1
Version: federal_register_of_legislation:F2017L00638
Segment Type: other
Provision Reference: 
Character Range: 0–3131

Therapeutic Goods Information Specification 2017

Therapeutic Goods Act 1989

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

Dated 31st May 2017

(Signed by)

LARRY KELLY

Delegate of the Minister for Health

1 Name of Specification
  This Specification is the Therapeutic Goods Information Specification 2017.
2 Commencement
  This Specification commences on the day after it is registered.
3 Repeal
  This Specification repeals the Therapeutic Goods Information Specification 2015.
4 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.
       TGA means the Therapeutic Goods Administration which is part of the Department of Health.
5 Therapeutic goods information
  The kinds of therapeutic goods information in Schedule 1 are specified under subsection 61(5D) of the Act for the purposes of subsection 61(5C) of the Act.

   Therapeutic Goods Information Specification 2017  1

 Schedule 1               Specified kinds of therapeutic goods information
(section 5)

The following kinds of therapeutic goods information:
    Note: The following specified kinds of therapeutic goods information may be released by the Secretary to the public under subsection 61(5C) of the Act.
 1 Product information approved by the Secretary under subsection 25AA(1) or 25AA(4) of the Act in relation to therapeutic goods.
 2 Information required by regulation 9A or 9B of the Regulations to be supplied with certain therapeutic goods.
 3 Information in documents prepared for the purpose of evaluating therapeutic goods under subsection 25(1) or subsection 9D(3) of the Act.
 4 Information in relation to post-market pharmacovigilance requirements imposed by the Secretary under section 28 of the Act as a condition of registration on therapeutic goods or by a regulation made for the purposes of paragraph 28(5)(e) of the Act.
 5 Information in documents relating to assessments made of the pharmacovigilance system, quality and non-clinical and clinical data in relation to therapeutic goods for the purpose of evaluating those goods under subsection 25(1) or subsection 9D(3) of the Act.
 6 Information in documents included in a request of the Secretary to:
          * the Advisory Committee on Medicines (ACM) or its subcommittees or
          * the Advisory Committee on Vaccines (ACV),
seeking advice in relation to the evaluation of therapeutic goods under subsection 25(1) of the Act or subsection 9D(3) of the Act, including in relation to post-market pharmacovigilance requirements and the continued suitability for registration of therapeutic goods.
 7 Information in the minutes or outcomes of ACM or its subcommittees, or ACV, about the evaluation of therapeutic goods under subsection 25(1) or subsection 9D(3) of the Act, including in relation to post-market pharmacovigilance requirements.
 8 Information in the minutes or outcomes of any