Technical Alerts

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.

The Permitted Indication Determination No. 1 of 2018 and associated TGA guidance is now available. The Listed Medicines application system with Permitted Indications is available today. More information here.

The Therapeutic Goods Amendment Bill No 1. of 2017 has received Royal Assent. The reforms are being implemented from today. More information here.