5.8 Providing documents after lodging a submission
For submissions where the TGA delegate’s overview is provided with the submission documents, additional regulatory documents may be updated while the submission is being considered by the PBAC. Sponsors should provide the PBAC with electronic versions of any TGA documentation such as updated Product Information, confirmation of registration on the Australian Register of Therapeutic Goods, an AusPAR or a TGA Risk Management Plan.
For submissions evaluated under the TGA parallel process (medicines only), the relevant TGA documents not available when the submission is lodged (including the clinical evaluator’s report, TGA delegate’s overview and the recommendation of the Advisory Committee on Prescription Medicines) should be provided to the department as soon as possible.
New clinical evidence or cost-effectiveness analyses are generally not accepted once evaluation of major submissions is under way. However, if the sponsor becomes aware of new publications or further data analyses that have relevance to consideration of the submission by the PBAC, the sponsor should contact the PBAC Secretariat to discuss the potential effect of this information (refer to Appendix A for contact details).