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Tech Alert: New Permissible Ingredients Determination (No. 2) 2021

13 Aug 2021 2:02 PM | Anonymous member (Administrator)

Permissible Ingredients Determination

A new permissible Ingredients Determination (No.2) 2021 has commenced. 

This technical Alert (available in Word and 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 alert also summarises changes to ingredients including:

  • New requirements for Artemisia annua and Artemisia absinthum
  • Changes to ingredients such as magnesium amino acid chelate and oligofructose;
  • The addition of substances permissible for use in flavours /fragrances /proprietary formulas; and  
  • The addition of the following 2 new ingredients for use in listed and assessed listed medicines: sodium butyrate (active and excipient) and lacto-N-neotetraose (active).

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