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Tech Alert: New Permissible Ingredients Determination (No. 4) 2020

16 Dec 2020 8:14 AM | Anonymous member (Administrator)

A new Permissible Ingredients Determination (No.4)2020 has commenced.

This technical Alert (available in Word or PDF) contains a detailed list of changes with a Notes field for sponsors to use to assist in identifying the changes relevant to products, as part of a table which includes

-Each new or changed ingredient

The original (previous) requirements that applied

New (amended) specific requirements.

This update also includes information on the following substances with more context provided for members on background information leading to the changes: 

- Fallopia multiflora (He Shou Wu or Fo-Ti)

- Arbutin-containing herbs updated to reflect the poisons Standard and increase market access

- Change of transition periods from 'supply' to 'release for supply'

- Other changes to the Determination, including the addition of 27 new ingredients and the expiration of exclusivity on 3 ingredients

In addition, this technical alert includes information on:

 - Targeted industry consultation via CMA on TGA-proposed removal of Gynura japonica from the Permissible Ingredients Determination in March 2021 (closes via CMA on 6 January 2021).

Proprietary Ingredient Consultation delayed until January 2021

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