Overview of product types and fees of the Veterinary Medicinal Products Unit.
Current fees and product types
The Veterinary Medicinal Products Unit charges costs for work that it performs. Costs are charged, for example, for the application and change procedures relating to a marketing authorisation for veterinary medicinal products. Marketing authorisation holders also pay an annual fee for each marketing authorisation. An overview is available of the current fees (also referred to as duties (retributies)). These fees are based on the Veterinary Medicines Regulations (Regeling diergeneesmiddelen), which date from 2013. A product type is linked to each fee. If you are submitting an application, it is important that you refer to this product type. The right fee will then be linked to your application.
Changes to the fees and product types as of 28 January 2022
Once the Veterinary Medical Products Regulation has come into effect on 28 January 2022, the fees for the application procedures and the annual fee will remain the same for the year 2022. The Veterinary Medicinal Products Unit has decided to set the new fees as of 2022.
The fee depends on the work performed by the Veterinary Medicinal Products Unit when processing an application. It is not yet clear how much work these changes will entail as regards the amended and new procedures. The Veterinary Medicinal Products Unit will use the year 2022 to obtain a clearer picture of this work. The new (substantiated) fees for 2023 will be determined on the basis of that information.
Conversion of the rates
The principal change in procedures under the Veterinary Medical Products Regulation is the introduction of a new classification system of changes to existing marketing authorisations. A list has been drawn up of changes for which a scientific assessment is no longer required. Changes not stated on this list are changes for which an assessment is required. In the current regulations, changes are classified as Type IA, Type IB and Type II changes, but this classification will no longer apply.
After 28 January 2022, the fees for new activities will be temporarily linked to the fees for comparable old activities. With this in mind, the Veterinary Medicinal Products Unit will use a conversion table that compares the old situation to the new one. This conversion table will be published on the website before 28 January 2022.
The fees which the Veterinary Medicinal Products Unit will charge for the new changes will be those that already apply to Type IA, Type IB and Type II changes. For example, in the case of a change for which no assessment is required, the IA change fee will be used.
Applications submitted after 28 January 2022
On 28 January 2022, the Overview of fees and product types of the Veterinary Medicinal Products Unit will be updated. In particular, a number of product types will be changed. You should therefore check carefully in advance whether you are using the right product type in your application.
Fees for 2023
The new (substantiated) fees for 2023 will be determined in 2023. This will be done using the information that becomes available in 2022 regarding the quantity of work for each new or changed procedure.
MEB payment conditions
Pursuant to the Medicines Act, a fee is owed for the processing of every application, regardless of the course of this process. The fee for the processing of an application is owed by the applicant at the time of submission of an application. For each marketing authorisation that is maintained, the authorisation holder is liable to pay a recurrent fee on an annual basis.
For payment of the fee for the processing of an application for a (parallel) marketing authorisation, the applicant will receive an invoice once the application has been received. With regard to the annual fee, the authorisation holder will receive an invoice - for the fee owed - in March or April of that year. The marketing authorisation holder must pay a fee for the authorisations that are authorised as from 1 January of the calendar year concerned.
In summary, the payment process of the MEB is as follows. The amount stated on the invoice must be paid within 30 days. Once this period has expired - and the fee has not been paid yet - you will be summoned to pay the amount on the invoice within 30 days. If the invoice has not been paid after this period, the MEB will transfer the invoice to a debt collection agency.
The payment process of the MEB is as follows:
- The term for payment of your invoice is 30 days.
- You must transfer the amount stated on the invoice to bank account number
NL11 INGB 0705003485 in the name of CBG/MEB in Utrecht (Swift code / BIC: INGBNL2A). Always state the payment reference (invoice number and debtor number) with your payment.
Notice of default: If we have not received full payment from you within 30 days of the date on the invoice, we will send you a reminder (payment reminder). This is considered a notice of default. The MEB retains the right to suspend the processing until the full amount of the invoice has been credited to the MEB bank account.
Reasonable period of time: The payment reminder gives you a further opportunity to pay us the amount on the invoice within 30 days.
Default: If we have not received full payment from you within 30 days of the date on the payment reminder, you will have defaulted on the payment.
If you have not paid the amount on the invoice (in full) after the notice period, you will have defaulted on the payment and the MEB will engage a debt collection agency to recover this amount.
All legal and/or extra-judicial costs, including legal interest, related to the recovery of the invoiced amounts will be charged to you.
Your payment will first go towards reducing the recovery costs, then towards reducing the interest and finally towards reducing the principal debt.
If the unpaid invoice relates to the annual fee and you have defaulted on the payment, the MEB can suspend the marketing authorisation.
Withdrawal requests per 31 December (the year-end withdrawals) must be received by the Veterinary Medicinal Products Unit (VMPU) on 1 December at the latest, in order to go into effect per 1 January.
In case your withdrawal request is received at a later moment, it might not be complete by the end of the year. In that case you might have to pay the annual fee for the subsequent year.