TGA’s Amendments to TGO 91, and 92. What Should You Decode?

TGA’s Amendments to TGO 91, and 92. What Should You Decode?

Since 31st August 2016, the Therapeutic Goods Administration (TGA) is continuously working to update its guidelines for labeling of medicines supplied in Australia to ensure companies be aligned with international labeling best practices and reduce medication errors. As part of the ongoing changes, following the recent updates in August, the Australian Health Authority, post consulting different stakeholders and decoding their views, has announced few amendments to the new labeling orders.

  • The Therapeutic Goods Order No. 91 (TGO 91) for labels of prescription and related medicines, and
  • The Therapeutic Goods Order No. 92 (TGO 92) for labels of non-prescription medicines.

The agency opines that the general changes are necessary to:

  • replace the name of new Therapeutics Goods Order 69 updated in 2017, removing the older Therapeutics Goods Order 69
  • provide that medicines which do not require to be included in the Register before their lawful supply under the health practitioner notification arrangement under subsection 19(7A) of the recently included, Therapeutic Goods Amendment (2016 Measures No.1) Act 2017, are not required to comply with the Orders

However, with the deadline set for transition is just three years away, i.e. 2020, decoding the TGA Labeling Orders (TGO 91 and TGO 92) can be a bottleneck for the sponsors. Organizations who wish to market their product in Australia are required to consult a local/regional Regulatory expert to decode the therapeutic goods for which these orders apply, and for which these are exempted, what should be the information to be included on the label and on the main label and what are the special requirements, if any. Be compliant with the regional Regulatory best practices followed.

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