As a sponsor of medicines approved for supply in Australia, you are legally responsible for meeting pharmacovigilance reporting requirements for your medicine. The sponsor must:
- Advise the TGA who your Australian pharmacovigilance contact person is
- Submit any serious adverse reaction reports to the TGA
- Notify the TGA of any significant safety issues you identify
- Keep records pertaining to the reporting requirements and safety for your medicine (under Subsection 28(5)(ca) of the Therapeutic Goods Act 1989 (the Act))
- Answer any request from the TGA for additional information fully and within the specified timeframe (under Subsection 31(1) of the Act).
The TGA expects the sponsor to have an effective pharmacovigilance system in place in order to:
- monitor and take responsibility for the safety of your medicine
- meet legislative requirements for reporting serious adverse reactions and significant safety issues
- identify any changes to the benefit–risk balance of your medicine
- take appropriate action in a timely manner when necessary
- update product labels and product information (PI) with new safety information in a timely way.
A list of frequently asked questions can be found here.