The MEB Agency’s Veterinary Medicinal Products Unit (VMPU) handles and assesses applications and issues production, distribution and marketing authorisations for veterinary medicinal products. The VMPU issues recommendations on applications to the Ministry of Agriculture, Nature and Food Quality (LNV) via the Committee for the Authorisation of Veterinary Medicines (Ctd). The Minister of Agriculture, Nature and Food Quality is responsible for the marketing authorisation of veterinary medicinal products. The VMPU is also tasked with monitoring adverse reactions, granting trial exemptions for veterinary medicinal products and feed additives, as well as issuing batch approvals for veterinary vaccines, export certificates and authorisations for wholesale and retail trade.
Inspections
In January 2019, the MEB Agency took over veterinary inspections for pharmacovigilance from the Health and Youth Care Inspectorate (IGJ). The VMPU carried out one inspection in 2022, in the context of pharmacovigilance (PSMF).
Assigned centralised CVMP rapporteurships and co-rapporteurships
Het aCBG kreeg in 2022 4 rapporteurschappen en 3 co-rapporteurschappen binnen de CVMP toegewezen. Het jaar 2021 was een uitschieter. Het aantal was toen hoog, omdat het merendeel van de rapporteurschappen deel uitmaakte van een bundel rapporteurschappen.
Assigned centralised (co-)rapporteurships
| 2018 | 2019 | 2020 | 2021 | 2022 | |
|---|---|---|---|---|---|
| Assigned centralised (co-)rapporteurships CVMP | 5 | 4 | 1 | 16 | 7 |
Assigned centralised (co-)rapporteurships MRL
An MRL (maximum residue limit) must be established for substances that are intended for use as medicinal products in food-producing animals. The rapporteur for an MRL application assesses the maximum safe concentration of the residue of an active substance in the various consumable products of animal origin.
No MRL rapporteurships or co-rapporteurships were assigned to the MEB Agency in 2022.
Assigned central (co-)rapporteurships
| 2018 | 2019 | 2020 | 2021 | 2022 | |
|---|---|---|---|---|---|
| Assigned central (co-)rapporteurships MRL | 3 | 2 | 2 | 0 | 0 |
Concluded RMS applications via the mutual recognition and decentralised procedure
The Netherlands concluded 28 DCP applications as a reference member state (RMS) in 2022. This number is comparable to the previous year. The Netherlands has a large share within Europe. After France, the Netherlands concluded the most RMS applications.
Concluded RMS applications
| MRP | DCP | |
|---|---|---|
| 2018 | 2 | 14 |
| 2019 | 1 | 41 |
| 2020 | 0 | 40 |
| 2021 | 0 | 30 |
| 2022 | 0 | 28 |
Concluded RMS applications
| Country | Number |
|---|---|
| Ireland | 25 |
| France | 31 |
| Spain | 18 |
| The Netherlands | 28 |
| Germany | 7 |
| Czech republic | 9 |
| Hungary | 2 |
| Estonia | 1 |
| Italy | 2 |
| Austria | 1 |
| Norway | 1 |
| Poland | 0 |
| Portugal | 1 |
| Sweden | 0 |
| Denmark | 2 |
| Finland | 0 |
| Slovenia | 0 |
| Slovakia | 0 |
| Belgium | 0 |
Number of marketing authorisations
Last year, there was an increase in the number of marketing authorisations for veterinary medicinal products registered in the Netherlands.
Number of marketing authorisations after registration
| 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | |
|---|---|---|---|---|---|---|
| Number of marketing authorisations after registration | 2271 | 2292 | 2329 | 2382 | 2349 | 2877 |
Number of withdrawals
2022 saw a slight rise in the number of withdrawals of marketing authorisations for veterinary medicinal products at the request of the marketing authorisation holder.
Withdrawals after registration
| 2018 | 2019 | 2020 | 2021 | 2022 | |
|---|---|---|---|---|---|
| Number of withdrawals | 108 | 98 | 60 | 139 | 145 |
