You can use this application form to apply for biologicals (priority applicant) determination.
You must hold a valid (priority applicant) determination before applying for inclusion of your biologicals in ARTG via priority review pathway.
Sponsors must complete the form, including declaration and submit along with supporting documentation to bloodandtissues@health.gov.au.
Further information on the application process is available at Biologicals (priority applicant) determination A step-by step guide.
Form
The 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.