The new label standard for non prescription medicines commenced on 30 September 2026. Here is what moves, who it affects and how long you have.
Plumb | Published 15 October 2026 | 6 minute readTGO 116 sets how information is grouped and presented on a medicine label, including how active ingredients are named and which statements must appear on the main panel.
Every sponsor of a listed medicine, which means every label in your range. Larger dosage forms and products with many active ingredients are worth checking first.
The standard commenced on 30 September 2026. Products released for supply after 1 October 2031 must comply.
List every label in your range, map each one against the new requirements, and plan the changes into your next print runs so you are not reprinting twice.
1. Therapeutic Goods Administration, Therapeutic Goods Order No. 116. 2. TGA, medicine labelling guidance for sponsors.
Our TGO 116 label review covers every label, with a transition plan.
Which pathway your product takes, and why it matters.
ClaimsHow to say what your product does without crossing it.
EnforcementWhat the letter asks for, and how to respond.
Tell us where your product is at, and we will come back with a plan.