Federal Register of Legislation - Australian Government

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Specifications as made
This instrument permits the Secretary of the Department of Health to release to the public specified kinds of information under subsection 61(5C) of the Therapeutic Goods Act 1989.
Administered by: Health
Made 26 Nov 2015
Registered 01 Dec 2015
Tabled HR 02 Dec 2015
Tabled Senate 03 Dec 2015
Date of repeal 01 Jul 2018
Repealed by Therapeutic Goods Information (Outcomes of Advertising Complaints Investigations) Specification 2018

Therapeutic Goods Administration

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

Dated this 26th day of November 2015

(Signed by)

Lawrence Kelly


1              Name of Specification

                This Specification is the Therapeutic Goods Information (Outcomes of Advertising Complaints Investigations) Specification 2015.

2              Commencement

                This Specification commences on the day after it is registered.

3              Interpretation

In this Specification:

Act means the Therapeutic Goods Act 1989.

advertiser, in relation to an advertisement, has the same meaning as “person apparently responsible” as in regulation 42ZCAA of the Regulations.

ARTG means the Australian Register of Therapeutic Goods.

complaint has the same meaning as in regulation 42ZCAA of the Regulations.

complaint register means a register of complaints and related information published by the Complaints Resolution Panel on the Internet, under regulation 42ZCAL of the Regulations.

Panel means the committee, known as the Complaints Resolution Panel, established under regulation 42R of the Regulations.

recommendation means a recommendation of the Panel made under regulation 42ZCAI of the Regulations about an advertisement.

Regulations means the Therapeutic Goods Regulations 1990.

TGA means the Therapeutic Goods Administration, which is part of the Department of Health. 

4              Therapeutic goods information

 

The kinds of therapeutic goods information mentioned in Schedule 1 are specified for the purposes of subsection 61(5D) of the Act.


Schedule 1        Specified kinds of therapeutic goods information

(section 4)

 

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.

 

Kinds of therapeutic goods information relating to outcomes of TGA investigations into advertisements for therapeutic goods, following recommendations from the Panel arising out of a complaint about that advertisement

 

 

Item

Information

Description

(a)

Advertiser name

The name of the advertiser in relation to the advertisement that is the subject of the complaint and the recommendation to the Secretary (the advertisement).

(b)

Name of therapeutic goods

The name of the therapeutic goods that are the subject of the advertisement.

(c)

ARTG number

The ARTG number of the therapeutic goods.

(d)

Date recommendation received

The date the Panel’s recommendation relating to the advertisement was received by the Secretary.

(e)

Date investigation finalised

The date that the TGA’s investigation into the advertisement, following the recommendation from the Panel, was finalised.

(f)

Complaint summary

A summary of the complaint relating to the advertisement.

(g)

Panel’s determination

A reference, or link, to the Panel’s determination relating to the complaint, containing details of the complaint as published in the complaint register. 

(h)

Investigation outcome summary

A summary of the outcome of the TGA’s investigation into the advertisement, conducted after receipt of the Panel’s recommendation – this may also include a summary of any action taken by the advertiser in relation to the advertisement.

 

Note

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