Reformatting Product Information: frequently asked questions

TGA

6 March 2020 - A new product information form was approved on 8 November 2017, with a commencement date of 1 January 2018. 

From this date, product information (PI) documents that must accompany relevant registration applications will need to be prepared in accordance with the format of this new form. The PIs for all marketed products will need to be in the new format by 31 December 2020.

A revised version of this form was approved on 8 March 2018 following amendments to the Therapeutic Goods Act 1989 (the Act). The revised version includes updated references to the Act as well as updates to the form to improve its clarity and provide some additional instructions. These revisions do not change the form substantively from that which commenced in January 2018.

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Michael Wonder

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Michael Wonder