When applying for authorization of a plant protection product in the Northern Regulatory Zone, there are specific requirements in terms of efficacy trials that must be followed. These requirements are given in the “Guidance on requirements for efficacy data for zonal evaluation of a plant protection product in the Northern Zone”. An updated version (version 9.0, August 2022) of this guidance has just been implemented.
The updated version includes updated information on sufficient infestation in trials, number of trials when applying for seed treatment products and how to deal with low-risk products and biologicals.
The Annex 1 table with the minimum number of trials has been updated to include molluscicides and acaricides.
The updated guidance document and Annex 1 is available at Aarhus University homepage: https://agro.au.dk/en/collaboration/guidance-on-requirements-for-efficacy-data.
The Regulatory Consulting Department at Agrolab has dedicated Registration Specialists with expertise with plant protection product registration in the Northern Regulatory Zone.
If you have questions on efficacy data requirements in the Northern Zone, contact Dorte Højland Castberg, dhc@agrolab.dk, or Mandy Rauch, mr@agrolab.se. For specific project inquiries please contact director Kenneth Sørensen, ks@agrolab.dk, mobile +45 27 51 63 75.