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Tech alert: TGO 92 update – Section 14/14A consent to supply

14 Apr 2022 8:15 AM | Anonymous member (Administrator)

The TGA have advised that the public consultation of Therapeutic Goods Order 92 (TGO 92) has been delayed until mid-year, due to the release of other consultations and the Government caretaker period.

Intent of TGO 92 Consultation

The TGA have advised that the review of TGO 92 is not intended to introduce new labelling requirements, but to clarify existing requirements around issues such as dosage form and expression of product name, and to correct identified minor errors. These changes should largely provide extra flexibility and therefore reduce existing impacts. For example:

 - More flexibility around dosage form names on medicine labels.

 - Enabling most sponsors whom have section 14/14A consents for product names on medicine labels in relation to subsection 9(2) of TGO 92 to be compliant rather than non-compliant. Some sponsors have received section 14/14A consents to allow continued supply of those medicines and medicine labels with product names that may not conform to the TGA 92 labelling requirements in subsection 9(2). These exemptions are due to expire in September 2022. 

Medicine Names under section 9(2) – Section 14/14A consents

The TGA have provided that the revised TGO 92 is expected to be released by 1 September 2022 at which time most, if not all labels that are currently non-compliant with Section 9(2), will now be compliant.

If the updated TGO 92 is released by 1 September, this would therefore negate the need for further extensions to Section 14/14A exemptions for sponsors. However, if there are further delays to the timing, assurance has been provided to CMA by the TGA that affected sponsors who already hold a section 14/14A exemption will be contacted by the TGA, and a further section 14/14A extension provided to ensure business continuity.

While the outcome of the public consultation for all products cannot be guaranteed, the TGA have provided that, if there are a few sponsors who have already been granted a 14/14A exemption but find that their product(s) label continues to be non-compliant when the updated TGO 92 is released after public consultation, the TGA will make further arrangements for those sponsors for labelling to continue for period of time to allow transition.

The TGA have also provided that Therapeutic Goods Order 91 (TGO 91) for prescription medicines will be reviewed to align with the TGO 92 review. It is proposed that the TGO 92 and TGO 91 guidance will be separated to make it easier to separately refer to requirements for non-prescription and prescription medicines.

Any general queries or issues about the above may be directed to technical@cmaustralia.org.au, if you have queries about your specific product, please contact the TGA's Complementary Medicines & OTC Branch.

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