Description
- Regulatory framework
- Steps in preparing a listing application
- Prerequisites for the listing application
- Sponsor ID
- Authority to prepare / submit
- Required documentation / information
- Determine the medicine is eligible for listing
- Preparation of the listing application
- Validation of the listing application
- Submission of the listing application
- Certification / Declaration
- Conditions of listing
- Listing application tips
- Example listing application
- SOP Checklist supplied
- This course includes access to TGA Business Services (TBS) through RTD’s organisation for one participant. This one participant will be guided through the process of preparing and validating a listing application based on a mock Finished Product Specification prepared by RTD. This practical part of the session only allows for one participant to engage in the process of preparing and validating a listing application. If you book a session for multiple attendees, we recommend all participants be present in the same room so a large screen can be shared for the other participants to view the process. If all participants want TBS access and to prepare and validate a listing application during the live training separate course sessions will need to be booked and this will be changed accordingly.
Duration: 1.5 hrs
*10% GST is added if we are billing an Australian company
Extra attendees – $50 per person
