Technical Alerts

Today's technical alert includes information on the newly published Permissible Ingredients Determination, including a combined PDF of the 6 volumes for member's convenience and information about changes and transition arrangements. More information here.

The TGA has been assessing submissions to the consultation on the draft 2018 Therapeutic Goods Advertising Code and making changes accordingly, including many that are in accordance with the submissions from Complementary Medicines Australia and member companies.
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The TGA has published an update to the medicine labelling guidance, ‘Medicine labels: Guidance on TGO 91 and TGO 92’, on the TGA website. This version 1.1 of the guidance is the second version and replaces version 1.0 that was published in August 2016.

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- TGA Public Consultation & Survey: Options for the implementation of a claimer for efficacy assessed non-prescription medicines
- Priority Sponsor Review of Arbutin-containing Herbal Products
- Delayed changes to Caffeine in Listed Medicines – for further review
- CMA submission on Plain English Allergen Labelling in foods
- Mandatory Labelling of Lupin on Food Products in effect 26 May 2018
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The proposed new model for handling advertising complaints for therapeutic goods is open for consultation, available here on the TGA website.  Click Here to read more

A summary of the advertising reforms and proposed complaint handling procedures here

The following is now publicly available:

• Therapeutic Goods Advertising Code – Public Consultation
• Incorporated Therapeutic Goods Act 1989;
• New Ingredients - Updated Application Form and Guidance
• Guidance for pre-assessed medicine applications including AUST LA (Assessed Listed) and AUST R (Registered) Complementary Medicines
• ACCC Country of Origin Guidance for Complementary Healthcare Products
• Registration forms and program for the TGA Inaugural GMP Forum

The TGA has formally released the new Assessed Listed pathway for complementary medicines. More information including transition arrangements here.

The Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 making amendments for new ingredients and the new listed assessed pathway is now registered on the Federal Register of Legislation. Availability of the processes are pending TGA finalisation.

No action is currently required on Curcumin / Curcuminoids. For more information please click here.

The Permissible Ingredient Determination No. 1 of 2018 has been registered on the Federal Register of Legislation. The updated Therapeutic Goods Regulations containing important regulatory reform details for complementary medicines will be published this week. For more information, please click here.