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).