Is your business at risk of fines in excess of $13,000?
The TGA recently fined a sponsor $13,320 for not having advised the TGA of their pharmacovigilance contact person. Pharmacovigilance is a system to detect, assess, understand and prevent adverse effects and other medicine-related problems. Every sponsor must implement a system.
Notifying the TGA of a sponsor’s pharmacovigilance contact person is a requirement under the Therapeutic Goods Act 1989. Sponsors must provide the TGA with the contact details of a nominated pharmacovigilance contact person in Australia within 15 calendar days of your first medicine’s entry on the Australian Register of Therapeutic Goods (ARTG). If you have not done this you are at risk of being audited and/or fined as your company would be considered at high risk of not having a suitable PV system in place, given this is the first requirement in their pharmacovigilance responsibilities guidance.
Listed medicines are subject to TGA post-market reviews and audits for compliance with applicable standards and legislative requirements. It is your responsibility as the sponsor of listed medicines to ensure that you meet your pre and post market responsibilities or your product can be cancelled from the ARTG.
For example:
- Stability requirements: Sponsors must hold ongoing stability data to demonstrate the medicine meets all specifications for the shelf life of the medicine to substantiate the recommended storage conditions and the expiry date stated on the label.
- Pharmacovigilance (PV) requirements: The TGA’s Pharmacovigilance Inspection Program (PVIP) commenced on 1 September 2017 and any sponsor who has at least one medicine included in the ARTG can be subject to an inspection at any time. Sponsors must meet PV responsibilities which include record-keeping and reporting of adverse events and significant safety issues to the TGA.
Do you have a pharmacovigilance system in place?
Subsection 28(5)(ca) of the Therapeutic Goods Act 1989 requires sponsors of medicines to keep records pertaining to the reporting requirements and safety for their medicine.
Audits to date have shown that the TGA are taking pharmacovigilance seriously and the expectations are that all sponsors have a pharmacovigilance record-keeping and reporting system in place for all of their listed medicines.
AWRS offers a pharmacovigilance system which can be implemented with ease, immediately!
We have created a comprehensive system, based on the TGA guidelines for Pharmacovigilance ‘Pharmacovigilance responsibilities of medicine sponsors – Australian recommendations and requirements’ and outcomes of audits and with reference also to the EMA Pharmacovigilance Guidelines where the TGA Guidance documents were found wanting. Based on the comprehensive nature of the AWRS Pharmacovigilance System it takes minimal effort to implement to be ready for a TGA audit.
We also offer training to increase team knowledge and understanding
As an extension to the AWRS Pharmacovigilance System, we also offer a training program (approx 3 hours duration) for sponsors and their nominated pharmacovigilance staff that can be completed via Zoom, Teams or in person.
Please contact us for more information or to purchase this system.
