Amoeba: slight delay in the calendar of European regulatory dossiers











Photo credit © Amoeba


(Boursier.com) — Amoeba has updated the regulatory schedule for its applications currently under evaluation in Europe.

Regarding the biocidal application in Europe, the application for approval of the active substance, submitted in 2019, is currently being assessed by the Maltese authority (MCCAA). In November 2021, the Maltese authority had undertaken to submit the active substance assessment report to the company no later than March 31, 2022. In March 2022, the MCCAA informed Amoéba that a few additional weeks would be needed to fully finalize the evaluation report.

Regarding the biocontrol application in Europe, the application for approval of the active substance, submitted in 2020, is currently being assessed by the Austrian authority (AGES). In December 2021, AGES informed the Company that the valuation report should be finalized at the end of March 2022). In March 2022, AGES informed Amoéba that, due to the exceptional pandemic situation in Austria, many expert assessors were either incapacitated or in quarantine, leading to an extension of the assessment for a few weeks.

For the other applications under evaluation (biocide in the USA and Canada; biocontrol in the USA and Brazil), the information provided in the press release of December 14, 2021 is still valid.


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