Therapeutic Goods Regulation & Advertising Compliance

​The conduct of clinical trials and the import, export, manufacture and supply of therapeutic goods (such as medicines, medical devices and complimentary medicines and nutritional supplements) in Australia requires compliance with the Therapeutic Goods Act which is administered by the Therapeutic Goods Administration (‘TGA’).  The regulatory regime for approval and advertising of therapeutic goods is complex. In some cases, foods, cosmetics and other products may be ‘therapeutic goods’ as defined by the Therapeutic Goods Act, requiring TGA approval and compliance with the Therapeutic Goods Act and Therapeutic Goods Advertising Code.

Stephens Lawyers & Consultants assists individuals and companies involved in the supply of therapeutic goods with compliance including:

  • Assistance with determination of whether product is a ‘therapeutic good’ and subject to compliance with the Therapeutic Goods Act and Therapeutic Goods Advertising Code
  • Advice in respect of whether certificate under section 26B(1) of Therapeutic Goods Act is required for registration of a medicine or notice of non-requirement for certificate under section 26B(1) can be given to the TGA
  • Review or audit of marketing and advertising material to ensure compliance Therapeutic Goods Act and Therapeutic Goods Advertising Code and Australian Consumer Law
  • Advice and assistance with responding to compliance concerns and infringement notices issued by the TGA in respect of non-compliance with the Therapeutic Goods Act and Therapeutic Goods Advertising Code
  • Advice and assistance with the development of training and educational programs for compliance with the Therapeutic Goods Act and Therapeutic Goods Advertising Code and the Australian Consumer Law

Stephens Lawyers & Consultants as a part of its dispute resolution and litigation practice represents individual and companies in disputes involving patent infringement and validity and in court proceedings commenced by the regulator for non-compliance with the Therapeutic Goods Act and the Therapeutic Goods Advertising Code.

Links to Publications

Regulation of Cosmetics in Australia – Stephens Lawyers & Consultants – May 2022

Advertising Compliance: Australian Consumer Law and Therapeutic Goods Act – February 2021