Pre-submission meeting forms

Purpose of pre-submission meetings

A meeting could help you and the TGA:

• reach a shared understanding of the therapeutic good
• clarify what documentation is required for evaluation
• identify issues to resolve before submitting applications
• plan for the submission timing and resource needs

Your form

• Your meeting request form must include enough detail for us to:
• determine whether a meeting is necessary
• identify the right experts to attend
• Use for  
  • Prescription medicine registration 
  • Orphan drug designation, 
  • Priority review prescription medicine designation
  • Over-the-counter medicine
  • Registered complementary medicine
  • Assessed listed complementary medicine
  • Ingredient for use in listed medicines
  • Biological (cell and tissue-based products)
  • Disinfectant (manufacturer or sponsor)

Indicate whether you prefer a teleconference, videoconference or in person meeting.

Email your request

Send the completed form 4 weeks to 2 months before your proposed meeting date to:

• Prescription medicines: streamlinedsubmission@tga.gov.au
• Non-prescription medicines: nonprescriptionmedicines@tga.gov.au
• Biologicals: send to the relevant TGA office
• Biologicals: bloodandtissues@health.gov.au

If meeting outside Canberra, you must organise the venue.