Pre-submission meetings with TGA

This guidance is for applicants (sponsors, manufacturers and agents) preparing for pre-submission meetings related to applications:

• to enter therapeutic goods on the Australian Register of Therapeutic Goods (ARTG). This includes all medicines, biologicals (cell and tissue-based products), medical devices and other listed and registered therapeutic goods
• for designation of prescription medicines, e.g. orphan drugs, priority review
• for TGA Conformity Assessment Certification (for the manufacture of medical devices)
• for priority applicant determination (medical devices).

It does not apply to applications for a manufacturing licence or Good Manufacturing Practice certification or clearance.

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