Mutual recognition
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
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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 requirements concerning environment and if necessary agriculture, Tukes requires the applicant to update the part A according the time of the mutual recognition application takes place in Tukes. These requirements comply with the current guidelines for the Northern zone.
- 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
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comparative assessment if the product contains an active substance that is a candidates for substitution.
- complete research material of the product
- Submit the composition data of the co formulants contained in the plant protection product or ask the manufacturer of the co formulants to provide the composition information of the co formulants contained in the plant protection product using this form. Compositional information must also be submitted for alternative co formulants. If the name of the plant protection product cannot be told to the co formulant manufacturer, ask Tukes for the code number for the plant protection product in order to supply the compositions of the co formulants.
- Submit the application with relevant documentation to the address ppp (at) tukes.fi
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You can submit research material through the applicant's own cloud service or alternatively send the material on CD disc (1 pc) by post to Tukes, P.O.Box 66, FI-00521 Helsinki.
Guidelines:
Processing time: 120 days