Australia’s Therapeutic Goods Administration (TGA) ends its pre-approval requirement for advertisements of medicines previously specified in Therapeutic Goods Regulations 1990. The ads can now be published or broadcast in established “specified media. ” The legislation ends it pre-approval requirement on 30th June 2020. This legislative, however, does not change the requirement for approval for the use of restricted representations. This approval requirement will remain.

Specified Media:

As of July 1, 2020, medicine advertisements in specified media will no longer need pre-approval from the Therapeutic Goods Administration (TGA). The TGA will continue to regulate the advertising of therapeutic goods, and advertisers must still meet the requirements under the therapeutic goods legislation, including the Therapeutic Goods Advertising Code.

“Specified media” which includes the following:

  • Magazines
  • Newspapers
  • Newsletters
  • Catalogues
  • Cinema advertising
  • Public displays about goods (posters, billboards and displays in/or public transport).

TGA changes to a Self-regulatory Approach:

 A broad range of enforcement powers have been put in place to support self-regulatory approach. TGA has set forward a set of guidelines for advertisers to comply with the regulatory framework as per the Australian Regulatory Guidelines for advertising Therapeutic Goods (ARGATG). According to  guidelines, the TGA can take any of the following actions is found non-compliant:

  • Educational letter or educational visits
  • Referral
  • Warning letter
  • Substantiation notice
  • Direction from the secretary
  • Suspension or cancellation of therapeutic goods from the ARTG
  • Public warning notice
  • Infringement notice
  • Enforceable undertakings
  • Criminal prosecution
  • Civil action

About Global Regulatory Partners:

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations..  To learn more, please contact us at  info@globalregulatorypartners.com

More Resources:

Australia’s TGA


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