The new Therapeutic Goods (Permissible Ingredients—Information that Must Accompany Application for Variation) Determination 2023 specifies specifies how applications for substances to vary the Permissible Ingredients Determination must be made. It requires sponsors to meet the information requirements included in the new guidelines, the ‘Mandatory requirements for an application to vary the Permissible Ingredients Determination’ for the evaluation of new substances.

The guidelines which sponsors must meet for new substances are:

• Application requirements for new substances in listed medicines
• Mandatory requirements for an application to vary the permissible ingredients determination
• Requirements for microorganism characterisation in Listed Medicines and Registered Complementary Medicines
• Guidance on using evaluation reports from Comparable Overseas Bodies

In addition, sponsors are still required to also comply with the General Guidance for Listed Medicines and Listed Medicines Evidence Guidelines.

If you need help figuring out how to navigate these requirements and guidelines, contact us to learn how we can support you.