Following the Therapeutic Goods Administration’s (“TGA”) Review of Medicines and Medical Devices Regulation a range of changes to the regulatory framework will be made between 2018 and 2020, with the first changes commencing last month.
The changes mainly relate to the four following areas:
increased penalties for non-compliant advertising from March 2018;
amended Therapeutic Goods Advertising Code from 1 July 2018;
a streamlined complaints handling system from 1 July 2018; and
abolishing the requirement for certain advertisements to be pre-approved from 1 July 2020.
The March 2018 changes amend the Therapeutic Goods Act 1989 by amending existing criminal offence sanctions and penalties, as well as introducing new sanctions and penalties, for example, civil penalties and infringement notices.
The broadened penalties and sanctions are intended to complement the TGA’s education and compliance program to achieve advertising compliance.
Read more about the current and future changes here.