You may remember that last month we featured one of our industry partners, Medical Ethics Pty Ltd.
They have recently completed a number of studies for their Tri-Solfen® anaesthetic and analgesia product. The objective being to verify the safety and efficacy in mitigating pain during and after piglet castration.
We spoke to Allan Giffard, Managing Director of Medical Ethics Pty Ltd to get an update on their progress with registration of the project within the EU.
Medical Ethics Pty Ltd has recently completed a number of studies of the Tri-Solfen® technology in piglets (including two major safety and efficacy studies conducted in Germany and Italy).
The objective of these is to fast-track the market approvals for the Tri-Solfen® technology to mitigate pain during and after piglet castration. The studies have enabled us to submit the first stage of the registration dossier with the European Medicines Agency (EMA) 12 months earlier than originally planned.
Market approvals a priority
Medical Ethics Pty Ltd has also commenced the market approvals stage for the technology in the EU and we are committed to providing a safe, cost efficient and practical solution for the mitigation of pain in piglets and other livestock species undergoing surgical procedures as we have successfully done in Australia and New Zealand.
- The minimal residue levels (MRL) dossiers were submitted to the EMA for Bupivacaine in June 2018 and for Lignocaine in September 2018 both have past the first validation.
- Once the review of the residues is completed we will submit a marketing approval in the EU (submission February to March 2019)
- If the EMA approves the application a market approval could be provided in the last half of 2019 or early 2020.