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

Assigned centralised (co-)rapporteurships CVMP
20182019202020212022
Assigned centralised (co-)rapporteurships CVMP541167
Source: EMA Source table as .csv (86 bytes)

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

Assigned central (co-)rapporteurships MRL
20182019202020212022
Assigned central (co-)rapporteurships MRL32200
Source: EMA Source table as .csv (80 bytes)

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

Concluded RMS applications via the mutual recognition (MRP) and decentralised procedure (DCP)
MRPDCP
2018214
2019141
2020040
2021030
2022028
Source: HMA Source table as .csv (65 bytes)

Concluded RMS applications

Concluded RMS applications via the mutual recognition and decentralised procedure
CountryNumber
Ireland25
France31
Spain18
The Netherlands28
Germany7
Czech republic9
Hungary2
Estonia1
Italy2
Austria1
Norway1
Poland0
Portugal1
Sweden0
Denmark2
Finland0
Slovenia0
Slovakia0
Belgium0
Source: EMA Source table as .csv (310 bytes)

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

Number of marketing authorisations after registration
201720182019202020212022
Number of marketing authorisations after registration227122922329238223492877
Source: MEB agency Source table as .csv (117 bytes)

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

Withdrawals after registration
20182019202020212022
Number of withdrawals1089860139145
Source: MEB agency Source table as .csv (68 bytes)