As an authorisation holder you may apply for an authorisation for the same plant protection product, the same use and under the comparable agricultural practices in another Member State under the mutual recognition procedure on the basis of an authorisation granted by another Member State, a reference Member State. Please note that the relevant biological efficacy trials must have been performed on an area where climate conditions are comparable to Finnish climate.
Official or scientific bodies or professional agricultural organisations may also apply for an authorisation.
Applying for an authorisation under the mutual recognition procedure
- Fill in the application form
- Include in the application:
- a registration report of the reference Member State as a Word file
a separate national part A of a registration report as a Word file. Part A has to be prepared according the Northern Zone guidance document valid at the time that the authorization has been sought in the reference country. In some cases Tukes can require the applicant to update the part A with a Northern zone guidance document which is valid at the time of the mutual recognition application in Tukes.
- the reference Member State's authorisation decision including a translation into Finnish, Swedish or English
- the reference Member State's instructions for use for the product in English
- justifications on the similarity of agriculture and climate
- GAP table
- draft label text in Finnish and Swedish
- if necessary, a letter proving the right to use the material of another company including the consideration of data protection and justifications
submit a predicted environmental concentration in soils for plant protection products calculated using the Nordic PECsoil calculator (calculator and user manual) and a risk assessment of the soil organisms prepared on the basis of the calculated results. However, for applications submitted earlier than 1.11.2018 it is allowed to calculate PECsoil using the Finnish PECsoil calculator.
- comparative assessment if the product contains an active substance that is a candidates for substitution.
- complete research material of the product
- Submit the application with relevant documentation to the address ppp (at) tukes.fi
- Send the research material on CD discs (3 pc) by post to Tukes, P.O.Box 66, FI-00521 Helsinki.
Processing time: 120 days
|Mutual recognition, Art. 40||basic fee 6,300 euros||additional evaluation 99 euros/h||maximum fee 15,000 euros|