Tariffs

Tariffs based on an advance payment and subsequent calculation

The application fees can be classified as follows. (All fees and the most important changes to fees can be found in the Tariffs Decree: Tariffs Decree 2025, Update Tariffs Degree 1 july 2024

1. Fees for applications for active substance or Maximum Residue Limit (MRL)

a. Applications actives substance dossiers

See Tariffs Decree, page 6: Addendum ll 1.a. Application for active substance - subsequent costing.

b. Derivation maximum residue limit (MRL)

See Tariffs Decree page 6: Addendum ll 1.b. Application for Maximal Residue Limit (MRL).

2. Fees for product applications

a. Zonal application for a plant protection product authorization with the Netherlands as the Zonal Rapporteur Member state (zRMS)

See Tariffs Decree, page 7: Addendum ll 2. a. Applications for which the Netherlands is zonal Rapporteur.

b. Zonal application for a plant protection product authorization with the Netherlands as a Concerned Member State (CMS)

See Tariffs Decree page 7: Addendum ll 2.b. Applications for which the Netherlands is Concerned Member State.

c. Mutual recognitions plant protection product authorization (WERG)

See Tariffs Decree, page 7: Addendum ll 2.c. Application Mutual Recognition.

d. National extension of a plant protection product authorization with a minor use(s) (NLKUG)

See Tariffs Decree, page 7: Addendum ll 2.e. Application for national extended authorisation with minor uses.

e. National application to amend the current authorisation (NLWG)

See Tariffs Decree, page 8: Addendum ll 2.f. Application for national amendment.

3. Other applications

a. See Tariffs Decree, page 8: Addendum ll 3a. Other application with limited assessment - fixed fee

b. See Tariffs Decree, page 9: Addendum ll 3b. Other application with assessment - fixed fee

See Tariffs Decree page 9: Addendum ll 3c. Other activities

Subsequent costing with advance fee

For most applications for active substances and most plant protection products it is difficult to predict in advance what the assessment cost will be. This is due to the diversity in the required assessment time amongst the different applications within one type of application. That is why fees for these applications are based on subsequent costing with an advance payment.

The total costs for an application are strongly determined by:

Number of active ingredients
Number of metabolites
Number of co-formulants
Whether there is one or there are two dRRs in the dossier
Number of uses requested / the amount of uses in the GAP table
Requested change / extension of the authorization
Number of studies to be evaluated
Presence of population model studies for mammals
Comparative assessment
The dossier quality: both of the dRR and the underlying documents and the consistency between those documents
The number of process steps that have been completed: the costs are lower for applications that are withdrawn by the applicant, or that are declared inadmissible after the intake.
Number of additional questions and response from the applicant
Number and nature of comments received from other Member States during the commenting round (NL=ZRMS)
Number and nature of core dossier subjects that have been transferred to Member State level (NL=CMS)
Clustering of applications based on the same active substance (for example with renewals) or for the same product.

As an indication, recent average costs and highest costs per application type are shown below.

Please note: depending on the contents of an application dossier, the costs for your application may be higher or lower than the average target prices in the tariff decree and may also be higher than the highest amount shown here. After the intake phase, the project manager can indicate what the expected cost for your dossier is based on.

Average and highest cost by application types

Application type	Average cost	Highest cost
Zonal application NL=ZRMS (ZTG)	€ 110,000	€ 220,000
Zonal application NL=ZRMS (low risk)^*	€ 61,000	€ 95,000
Zonal change application NL=ZRMS (.ZWTG)	€ 90,000	€ 196,000
Zonal change application NL=ZRMS (low risk)	€ 70,000	€ 122,000
Zonal renewal application NL=ZRMS^* (ZRG)	€ 115,000	€ 325,000
Zonal application NL=CMS (NLTG)	€ 35,000	€ 77,000
Zonal change application NL=CMS (NLWTG)	€ 22,000	€ 38,000
Zonal renewal application NL=CMS (NLRG)	€ 45,000	€ 112,000
Mutual recognition application (NLWERGZ)	€ 25,000	€ 65,000
National change application (NLWG)	€ 7,000	€ 25,000
National extension minor uses (NLKUG)	€ 17,000	€ 57,000
Deriving a maximum residue limit (MRL)	€ 31,000	€ 69,000
EU substance: new active substance / renewal chemical (TGEURAP/TGEURAPR)	€ 390,000 / 375,000	€ 708,000 / € 783,000
EU substance: new active substance / renewal microorganism^* (TGEURAPM/ TGEURPRM)	€ 200,000 / n.t.b.	€ 263,000 / n.t.b.
EU substance confirmatory data (TGEURPCD)	n.t.b.	n.t.b.
EU substance co-rapporteur (TGEUCORA)	€ 18,000	€ 32,000

*There is an insufficient number of recently processed applications to provide a reliable indication of the expected costs.

There are at least three moments in the application process when an invoice is sent:

Invoice 1

Once the application has been received, the Ctgb will charge the application costs as an advance fee. The advance fee as indicated in the tariff decree is based on the average cost of a dossier up to and including the admissibility check (active substances) or the intake phase (plant protection products).

Invoice 2

After the admissibility check / intake, the Ctgb sends an advance fee invoice for the remainder of the application process. The amount of this advance fee is based on an estimate of the assessment costs for the dossier in question and average costs for the phases that follow the assessment. An adjustment is made for the remaining budget from the application fee (invoice 1). This is the amount charged to the applicant and is the most realistic estimate at that time of the cost of the entire application.

Final invoice

The entire application from intake to final decision will ultimately be invoiced based on the actual costs. Any remaining budget will be refunded. An exception to this rule are applications that are withdrawn before the dossier is actually submitted. In that case, the application fees already paid will not be refunded.

The Ctgb aims to limit the number of invoicing moments to the above three for product applications. An additional invoice applies for active substance applications prior to the start of the European peer review phase. For product and substance applications, it may be necessary to send an additional advance fee invoice in the meantime if the dossier requires more time investment than estimated in advance. When estimating the total costs of the application, averages are taken into account for the phases following the assessment phase, such as assessing additional information or processing comments from other Member States. During the intake it is not yet clear whether additional questions will be asked and how much time it will take to assess the additional information. This also depends on the applicant's answer: withdrawn applications take less time to assess than processing many additional studies.

Fixed fee

Fixed fees apply for other applications. Assessment costs may be charged in addition to the application fee.

Annual fee

In addition, the authorisation holder owes the Ctgb an annual fee for each authorsation. See Tariffs Decree, page 9: Addendum ll 4. Annual fee plant protection product.

Service desks request

Service desks request which have to be answered by scientific, procedural, legal or policy experts will be charged. If the answering of your question requires more than 5 hours you will receive an offer in advance. When you have received an offer it is possible to recall your question. Questions which require no more than 5 hours will be taken care of without prior offer. See Tariffs Decree, page 5: Addendum I Fees and charges, Service Desk.