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Advertisers Slapped With Infringement Notices For Non-Compliant Advertising Of Therapeutic Goods
Advertisers are reminded the Therapeutic Goods Advertising Code 2018 (TGAC) was recently amended by the Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument 2019.
Australia
13 Sep 2019
2
The Therapeutic Goods Administration Flexes Its Enforcement Muscles
The TGA has successfully brought a claim against Peptide Clinics Australia Pty Ltd for non-compliance with the new advertising regime which includes higher penalties for therapeutic goods advertising offences.
United States
16 Aug 2019
3
Implant Cards And Information Leaflets: Strengthening Requirements For Permanently Implantable Devices
In October 2017, a new regulatory regime consistent with the EU Medical Devices Regulation (MDR 2017/745) was introduced for implantable and active implantable devices supplied in Australia.
United States
23 Nov 2018
4
Increased Penalties Under The Australian Consumer Law Now In Effect
Increases to the financial penalties under the Australian Consumer Law (ACL) will come into effect on 1 September 2018 following the royal assent of the Treasury Laws Amendment Act 2018 (Act) on 31 August 2018.
Australia
9 Sep 2018
5
New Therapeutic Goods Advertising Code: What You Need To Know
The Therapeutic Goods Advertising Code (Code) is the latest legislative instrument to be implemented as part of the Australian Government's response ...
Australia
20 Jul 2018
6
How To Submit Advertising Complaints About Therapeutic Goods
As part of the recent advertising reforms, the Therapeutic Goods Administration (TGA) has now become the single agency for therapeutic goods advertising complaints management.
Australia
12 Jul 2018
7
Higher Penalties For Therapeutic Goods Advertising Offences
General advertising offences are contained in section 42DL of the Therapeutic Goods Act 1989 (the TG Act).
Australia
9 Mar 2018
8
New Therapeutic Goods Legislation: What You Need To Know
The Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017 passed through both Houses on 15 February 2018. The bills have yet to receive Royal Assent.
Australia
2 Mar 2018
9
ACCC's 2018 Enforcement Priorities: What You Need To Know
The ACCC has released its 2018 enforcement priorities. Industries targeted should review their compliance strategies and think about how they would respond to a regulatory enquiry.
Australia
1 Mar 2018
10
New Uniform Recall Procedure For Therapeutic Goods
The new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) was published on 3 October 2017. This version replaces its 2004 predecessor.
Australia
25 Jan 2018
11
Developments In The Australian Medicinal Cannabis Industry
There have been significant developments in the Australian medicinal cannabis industry with the Turnbull Government now permitting the export of Australian manufactured medicinal cannabis products.
Australia
12 Jan 2018
12
Advertising Of Unapproved Therapeutic Goods May Soon Be Permitted
The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017 (collectively, the Bills) propose to bring significant changes ...
Australia
20 Dec 2017
13
Aligns With The European Medical Device Regulatory Framework
In July 2017, the TGA sought comments from interested parties to further align Australian and European medical device regulatory requirements to...
Australia
6 Nov 2017
14
TGA Response: Changes To Accessing Unapproved Therapeutic Goods Through The Authorised Prescriber (AP) And Special Access Schemes (SAS)
Category B patients are those who require the use of unapproved therapeutic goods and do not have a life-threatening condition or illness.
Australia
19 Oct 2017
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