EFFECTIVE 01 Jan this year, all product information (PI) documents that must accompany relevant registration applications will need to be prepared in accordance with the format of the new form which was approved 08 Nov 17, the Therapeutic Goods Administration (TGA) has said.
Further, the PIs for all marketed products will need to be in the new format by 31 Dec 2020.
The TGA has developed a Frequently Asked Questions (FAQ)section on its site to assist sponsors with reformatting their approved PI, or preparing a new PI in the revised format.
The FAQ section addresses the rationale behind changes, timing requirements, transitional arrangements and associated changes such as package inserts.
Visit tga.gov.au for access.
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