A new Product Information (PI) form was approved on 8 November 2017, with a commencement date of 1 January 2018. The new format is being introduced with a 3-year transition period, ending 31 December 2020. The new form brings the critical clinical information together at the front of the PI. It also aligns with the format used in Europe and New Zealand, reducing the burden for sponsors preparing new PIs for use in Australia.
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.
The Reformatting Product Information page has been updated to provide more detailed advice on these changes.
If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
Restricted medicine specification 2011
The Restricted Medicine Specification 2011 lists the medicines or classes of medicine that are to be 'restricted medicines' for which a draft PI document is required as part of the submission dossier.
Approval of the form
Approval of the form, under subsection 7D(1) of the Therapeutic Goods Act 1989, for providing PI for a restricted medicine or other medicine in relation to which the secretary requires Product Information to be provided.
Form for providing Product Information
As a part of an application to register a restricted medicine, a draft PI document must be lodged in a form approved by the secretary under section 7D(1) of the Therapeutic Goods Act 1989.
This form is specified in the approved form for Product Information.
Reformatting Product Information
The TGA has developed a frequently asked questions page to assist sponsors with reformatting their existing PI and drafting new PIs in the updated format.