Fees for processing applications for approval of pesticide active substances and authorisation of Plant Protection Products
The Danish EPA levies a fee on its work on all applications for pesticides.
The fees shall cover all costs associated with the processing of applications in accordance with the rules of the Pesticides Regulation and the Danish Pesticides Order. The fees are charged upon receipt of the application and must be paid to the Danish Environmental Protection Agency.
- The current fees can be found here
For applications where the total fee exceeds DKK 60,000, an amount of DKK 20,000 is charged to cover the Danish Environmental Protection Agency's initial processing of the application. The remaining part of the fee will only be charged once the application is assessed as being complete.
For applications for minor uses, derogations, parallel imports and administrative changes, the fee will be charged upon receipt.
In 2020, the Danish EPA revised the fees and compared them to the time spent by the agency on the different types of applications. This has led to an adjustment of the fees. As a result of a demand for further application types, there has also been an adaptation of the options for application. This adjustment implies that different types of fees (basic fee and additional fee) are differentiated from broad and relatively expensive categories to more specific and cheaper categories.
The fees are composed of a basic fee for the different application types with different supplements, which e.g. depends on whether the uses applied for include crops that can be used for food and feed, and whether it includes a new active substance in Denmark or a reassessment of an already approved active substance. The fees are regulated annually based on price indexation published by the Ministry of Finance.
The fee for an active substance evaluation by the Danish EPA with a view to its inclusion on the list of approved active substances in the Pesticide Regulation is calculated according to the time used on evaluation and may in 2021 amount to a maximum of DKK 2,002,000.
The new adjusted fees entered into force on January 1, 2021.
Renewals of plant protection products
A full approval fee will be charged for the first renewal of authorisation. Authorisation of subsequent applications with the same active substance will not be subject to the fee in Column C.
Assessment of equivalence
The Danish Environmental Protection Agency does not charge a fee when the equivalence assessment has been carried out by another country.
When the Danish Environmental Protection Agency receives an application for derogation of a specific plant protection product that extends over several periods against the same pest in the same year, it will be considered as one application.
When the Danish Environmental Protection Agency has previously evaluated and granted a derogation for the product in question for the same use, a lower fee will be requested.
The basic amount for an application for experimental testing will be charged in the case of a product with an active substance that is approved in Denmark. In the case of a product with an active substance that is not approved in Denmark, an additional fee will be charged.
Only one fee will be charged for an application for a minor application for different crops within the same crop type. This means that applications for e.g. different garden seeds can be treated together. The fee also covers several comparable products (eg products with the same active substance content, which are covered by the same evaluation) in the same application.
The additional fee to AGRO is not a supplement for the evaluation of efficacy, but rather for assessment of whether there exist authorised products with the application in question. This is done to protect the rights of the companies that have applied for a real product authorisation for that specific use and financed studies in that regard. AGRO also assesses whether it is legitimate to give authorisation for minor uses to a product with a different mode of action due to issues of resistance or other reasons.
Regarding the supplement to FVST/DTU, there are two different fees: a full fee if it is necessary to assess new residue data (to be submitted by the applicant), and a lower fee if the residues can be extrapolated from existing data . A fee is charged for each active substance in the product.
In the case of a transfer of a minor application to an identical product, it is considered as an administrative transfer that will be covered by the fee for simple administrative updates.
Fees for having a minor use applied to the label must be covered by the authorisation holder. If this happens in connection with another amendment of the label, no new fee will be charged.
Fee for assessments of active substances for EU approval / renewal
When the Danish Environmental Protection Agency is Co-RMS for an active substance, the amount of the fee to be charged is calculated based on estimated time consumption for the specific agreed division of tasks between the RMS and the co-RMS regarding the active substance in question and the fee is paid in installments as before. Reimbursement is also given for active substance evaluations if the resource consumption is lower than estimated.