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Notification of an authorisation to use a protected ingredient

17 September 2020

This form is to be completed by the ingredient owner to authorise sponsors to use a protected ingredient that is the subject of an exclusivity period to list a medicine in the Register.

The ingredient owner is the person named in the Therapeutic Goods (Permissible Ingredients) Determination as having exclusive use of the protected ingredient in a listed medicine.

There is no fee required for this notification but it must be submitted along with or after an Application for evaluation of a substance for use in listed complementary medicines form.

Please ensure you read Part C of the Australian Regulatory Guidelines for Registered Complementary and Listed Medicines (ARGCM) prior to completing and submitting this form.

Form

How to access a pdf or Word document

This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.