THE Therapeutic Goods Administration (TGA) has announced the adoption of a new format for the layout of product information (PI).
The new form was approved 08 Nov and will begin to be used effective from 01 Jan 2018 with a three-year transition period ending on 31 Dec 2020.
Aligning with the format used in Europe and New Zealand, the new layout places critical clinical information towards the front of the PI, the TGA said, adding that the alignment would reduce the burden for sponsors preparing new PIs for use in Australia.
Headings and subheadings have also been updated to align with headings used internationally.
The TGA has posted an FAQ page on its website - tga.gov.au.
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