Veterinary Medicinal Products Unit Fees for 2022
A lot of procedures are going to change as a consequence of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), which is coming into effect on 28 January 2022, for example the classification of changes (also referred to as variations) to a marketing authorisation. Because of these changes the current fee structure is being reviewed and amended where necessary.
Fees and product types
The Veterinary Medicinal Products Unit charges costs for the 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 they hold.
An overview of the current fees (also referred to as duties) can be found here. These fees are derived from the current Veterinary Medicinal Products Regulations, 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 VMR has come into effect, 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 is determined by the work performed by the Veterinary Medicinal Products Unit when processing an application procedure. It is not yet clear how much work these changes will entail as regards the amended and new procedures.
For that reason the Veterinary Medicinal Products Unit is using 2022 as the baseline year to determine appropriate fee changes. The new (substantiated) fees for 2023 will be determined on the basis of that information.
What changes will apply for 2022?
The most important change in procedures in the VMR is the introduction of a new classification system of changes in existing marketing authorisations. As a consequence of the VMR a list has therefore been drawn up of variations for which a scientific assessment is no longer required.
Variations not stated on this list are changes for which an assessment is required. In the current regulations variations 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 the Veterinary Medicinal Products Unit will start charging for the new changes will be those that already apply to Type IA, Type IB and Type II variations. For example, in the case of a variation for which no assessment is required, the IA variation fee will be used.
Applications submitted after 28 January 2022
After 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.
What changes will apply for 2023?
New (substantiated) fees 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.
Stay up to date
During the coming months the Veterinary Medicinal Products Unit is going to organise various online information meetings (in Dutch) to answer your questions about the Veterinary Medicinal Products Regulation.