Benchmark Holdings PLC (LON:BMK) has revealed that the European Medicine Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has adopted an opinion recommending the inclusion of BMK08's active pharmaceutical ingredient in fin fish as an allowed substance regarding maximum residue limits (MRL) in foodstuffs of animal origin.
The aquaculture biotechnology business noted that the MRL opinion is an important step towards the launch of BMK08 together with the company's water purification system CleanTreat in the second quarter of its financial year to end-September 2021.
It pointed out that the MRL opinion is without prejudice to the European Commission's decision and ratification into EU law, which represents the next milestone for BMK08 together with CleanTreat, and is a condition for obtaining Marketing Authorisation (MA) in Norway.
In a statement, Trond Wiliksen, Benchmark’s CEO commented: "The MRL opinion is a significant stepping stone towards the launch of our novel sea lice treatment BMK08, together with CleanTreat which purifies the treatment water. The positive opinion of the European Medicine Agency's experts in medicine safety is a critical step in a 10-year data collection and assessment process which ensures that the medicine is safe to use and safe for consumers."
"I congratulate our teams for getting us to this point and we look forward to making further progress towards a launch in Q2 CY 2021," he added.