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Notification of an authorisation to use a protected ingredient
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.
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.