Sponsors of registered and listed medicines are required to ensure that their medicines are safe and to have an effective Pharmacovigilance program in place.
We are ideally-placed to support organisations with a small-mid size medicine portfolio in Australia and New Zealand.
Our Pharmacovigilance roles and responsibilities model helps to identify activities best suited for outsourcing versus retaining in-house.
Our capabilities include
- An in-house Qualified Person for Pharmacovigilance
- Preparing and monitoring Pharmacovigilance training
- Preparation of local Risk Management Plan (Australian-Specific Annex), submission of Periodic Safety Update Report (PSURs)
- Literature surveillance
Pharmacovigilance for TGA listed medicines, including listed-assessed medicines and sunscreens
By definition, TGA listed medicines are low-risk medicines (listed-assessed medicines having intermediate-risk indication(s)). The TGA actively monitors listed medicines through both laboratory testing and compliance reviews to ensure they comply with all relevant requirements. It is mandatory to have an effective Pharmacovigilance program for TGA-regulated listed medicines.
Many sunscreens are regulated in Australia as TGA listed medicines. Listed medicine sunscreens are subject to he same Pharmacovigilance requirements as other listed medicines.
Our pragmatic yet compliant approach is tailored for low-risk listed medicine portfolios with relatively few cases of Adverse Events or Adverse Reactions.
Contact us for further information.
