Upcoming TGA Deadlines for Medicine Labelling and Product Information Reform


Author: Reena Patel

2020 was flagged to be a big year for TGA Sponsors of Medicines with two long-standing milestones on the horizon. Whilst there is no doubt this won’t be a year we forget in a hurry; it is timely to remind ourselves of some forthcoming deadlines.

Therapeutic Product Labelling Reform
The 31st of August 2020 marks the end of the medicines packaging reform which commenced in 2016. The intent of the reform was to make Australian medicine labels clearer and more informative for patients and consumers.

What is it and why is it happening?
The TGA introduced updated labelling requirements for medicines supplied in Australia that saw two new labelling orders to replace the existing Therapeutic Goods Order No. 69 – General requirements for labels of medicines (TGO 69):

These new labelling orders came into effect 31 August 2016, with a four-year transition period. During the transition period companies could choose to comply with the old labelling requirements under TGO 69 or the new labelling requirements. Sponsors can continue to store and supply medicines that are compliant with TGO 69 if they are released for supply on or before 31 August 2020. However, from 1 September 2020 all medicines released for supply must comply with either TGO 91 or TGO 92.

TGO 91 and TGO 92 are available on the Federal Register of Legislation and the TGA website includes a guidance document to assist companies update the labelling of products to comply with the new requirements.

What types of products are affected?
All therapeutic products registered on the Australian Register of Therapeutic Goods (ARTG) unless exempted in the applicable TGO.

What do I need to do?
If you have therapeutic products within scope, you should review your product labelling to ensure it complies with the applicable updated TGO. If not, you need to submit an application to the TGA to update your product labelling.

Anything else I should consider?
Yes! All medicines released for supply from 1 September 2020 must comply with TGO 91 or 92. Therefore, to ensure continuity of your medicine supply you may wish to confirm you have released sufficient stock for supply on or before 31 August 2020, and you have enough time to implement your revised labelling to avoid any disruption.

Product Information Reformat
Australian Product Information (PI) documents for marketed products will need to be in the TGA’s new format by 31 December 2020, marking the end of a 3-year transition period.

What is it and why is it happening?
The format of Australian Product Information (PI) documents were updated in November 2017. The format was developed in consultation with health professionals and sponsors to ensure critical clinical information was more accessible and structure aligned with the formatting requirements of comparable international regulatory agencies. The updated PI format came into effect on 1 January 2018, and a revised version of the Form for providing Product Information was approved on 8 March 2018. Revisions included updated references to the Therapeutic Goods Act, updates to improve Form clarity and additional instructions.

What types of products are affected?
In Australia, it is a legal requirement to have a PI for all restricted medicines and selected other medicines. Restricted medicines include:

  • Prescription medicines (ie all medicines in Schedules 4 and 8 of the Poisons Standard)
  • Pharmacist only medicines (ie medicines that contain a substance in Schedule 3 of the Poisons Standard)

PI’s can also be requested for other medicines that are being evaluated by the Prescription Medicines Authorisation Branch.

The deadline for implementation only applies to marketed products. PI’s for non-marketed products can remain in the old format, however they will need to be reformatted before the product can be marketed.

What do I need to do?
If your product has a PI, it is still in the old format, and you intend to supply your product from 1 January 2021, you need to submit an application to the TGA to update it. Reformatted PIs can be submitted with any other application type related to that medicine, including minor variations, safety related requests, and applications to update medicine ingredient names. Reformatted PIs submitted with any other application type do not attract an additional fee.

Reformatted PIs can also be submitted as a stand-alone application. Applications should be submitted as a Minor Editorial Change (MEC) through the TGA eBS portal, using the Prescription Medicine Minor Variation e-form. Applications where the only variation proposed is to reformat the PI, with no other editorial changes, will be exempt from fees between 1 January 2020 and 31 December 2020.

Anything else I should consider?
The TGA have recently updated the format requirements for Consumer Medicine Information (CMI) and released a new CMI template, so you might want to take the opportunity to update the CMI at the same time. You can find more information on the CMI reform here.Contact us


The contents of this article/presentation are solely the opinion of the author and do not represent the opinions of PharmaLex GmbH or its parent AmerisourceBergen Corporation. PharmaLex and AmerisourceBergen strongly encourage readers/listeners to review available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto.

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