Veterinary Medicinal Products Unit Fees for 2023 in revised Veterinary Medicinal Products Regulation 2022
With effect from 1 January 2023, the Medicines Evaluation Board (MEB) will be increasing the fees. The fees of the Veterinary Medicinal Products Unit will increase by 4.1%. This standard increase is necessary due to wage and price developments and for the organisation to cover all costs.
In addition to this standard increase in the regular fees, some new fees have been added and others revised. These are the result of new or updated procedures under the Veterinary Medicinal Products Regulation. The product types with a specific fee adjustment are listed in the table.
All fees charged by the Veterinary Medicinal Products Unit are included in the revised Veterinary Medicinal Products Regulation 2022. This revised Veterinary Medicinal Products Regulation will take effect on 1 January 2023.
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 the issuing of marketing authorisations and production and distribution licences for veterinary medicinal products. Marketing authorisation holders also pay an annual fee for each marketing authorisation they hold. A product type is linked to each fee.
Changes to the fees and product types as of 1 January 2023
Once the Veterinary Medicinal Products Regulation took effect on 28 January 2022, the application fees and the annual fee remained the same for the year 2022. For that reason, the Veterinary Medicinal Products Unit used 2022 as the baseline year to determine appropriate fee changes. The new (substantiated) fees for 2023 have been determined on the basis of that information. This applies to the product types listed below.
| Product type | Type of application | Fee 2022 (€) | Change | Fee 2023 (€) |
|---|---|---|---|---|
| 1014 | VRA-Standard | 8.626 | Decrease | 6.735 |
| 1020 | National WS VRA-Standard | 8.626 | Decrease | 6.735 |
| 1040 | RMS VRA-Standard | 8.626 | Decrease | 6.735 |
| 1057 | CMS VRA-Standard | 8.626 | Decrease | 4.490 |
| 1030 | Application DCP - RMS marketing authorisation generic or hybrid dossier | 8.959 | Increase | 14.187 |
| 1034 | Application MRP - RMS marketing authorisation generic or hybrid dossier | 8.959 | Increase | 14.187 |
| 1043 | RMS VRA-E in case initial marketing authorisation is generic or hybrid dossier | 8.959 | Increase | 14.187 |
| 1048 | Application for MRP - CMS marketing authorisation full dossier - food-producing animals | 13.628 | Decrease | 8.980 |
| 1058 | CMS VRA-E in case initial marketing authorisation full dossier (food-producing animals) | 13.628 | Decrease | 8.980 |
| 1093 (formerly PT 270) | Application for a wholesale licence (administrative) | 261 | Increase | 408 |
| 1094 (formerly PT 270) |
Application for a manufacturing licence (administrative) | 261 | Increase | 543 |
|
1096 (formerly PT 274) |
Change to the wholesale licence (administrative) | 104 | Increase | 162 |
|
1097 (formerly PT 274) |
Change to the manufacturing licence (administrative) | 104 | Increase | 217 |
| 1080 | Application for a wholesale licence (incl. company visit) |
522 | Increase | 668 |
| 1081 | Change to the wholesale licence (incl. company visit) |
365 | Increase | 570 |
The Veterinary Medicinal Products Unit overview of fees and product types lists the current fees as well as the fees that will take effect on 1 January 2023.
Amendments to the Veterinary Medicinal Products Regulation 2022 effective 1 January 2023
The Veterinary Medicinal Products Regulation 2022 took effect on 11 March 2022. This regulation serves to implement the Veterinary Medicinal Products Regulation on a national level. Because some points in this regulation still had to be amended or supplemented, a primarily technical adjustment has now been made to the Veterinary Medicinal Products Regulation 2022. Because this concerns a technical adjustment, most changes do not have much impact in terms of policy.
A number of changes do have substantive consequences, however. These concern changes that are a continuation of the old regulations. The changes in the Veterinary Medicinal Products Regulation 2022 are the result of the amendments in this regulation, which will take effect on 1 January 2023.
Stay up to date
On 30 January 2023, the Veterinary Medicinal Products Unit will be holding an online informational meeting titled ‘The Veterinary Medicinal Products Regulation: 1 year later’. You can still register to attend. For more information, see the news item about this informational meeting.
