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 a recommendation to the Ministry of Agriculture, Nature and Food Quality (LNV) via the Veterinary Medicines Board. In the Netherlands, 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.

European committees

The Committee for Medicinal Products for Veterinary Use (CVMP) is the scientific committee for veterinary medicinal products of the European Medicines Agency (EMA). All EU member states are represented in this committee.

The coordination of the European work in connection with the decentralised and the mutual recognition procedures is carried out by the Coordination Group for Mutual Recognition and Decentralised Procedures veterinary (CMDv). The CMDv is a scientific committee of the member states but, like the other committees, convenes at the EMA. The committee is also supported by the EMA. The Dutch representatives in both the CVMP and the CMDv work at the VMPU.

New European legislation

The year 2021 was marked by preparatory activities for the implementation of the Veterinary Medicinal Products Regulation and the Regulation on Medicated Feed. This legislation entered into force on 28 January 2022. In close cooperation with the Ministry of Agriculture, Nature and Food Quality, the VMPU is working at both the national and European level to ensure a smooth implementation. VMPU staff support the Ministry in the secondary legislation process, and the amendment of Dutch legislation. The Ministry has made an additional budget available for this. Thanks to this additional budget, the VMPU is able to play a role at crucial points in various European development processes.

National legislation, guidelines and procedures must not contain any duplication of the content of the European regulations. The Animals Act (Wet dieren), the Veterinary Medicinal Products Decree (Besluit diergeneesmiddelen) and the Veterinary Medicines Regulations (Regeling diergeneesmiddelen) have therefore been amended accordingly. Since processes are changing as a result of the regulations, these new processes have been detailed and published on the VMPU website. Three digital information meetings were held in late 2021 to inform stakeholders about all of the changes. Unfortunately, it was not yet possible to give clear answers to all questions raised by the sector. This is because the Netherlands, like other member states, is dependent in many respects on the final interpretation by the European Commission. Due to COVID-19, the process of drafting the secondary European legislation (referred to as delegated and implementing acts) has been delayed. This delay was not largely resolved until the end of 2021. The EMA has made substantial progress in developing the European product database.

From 28 January 2022, the database will contain all veterinary medicinal products authorised in the EU. This Union Product Database (UPD) will be the source of information on veterinary medicinal products for veterinarians and the public, and will also become the source file for EVvet3, the new European database of adverse reactions to veterinary medicinal products. The VMPU has converted the necessary information for all veterinary medicinal products authorised in the Netherlands to the required format so that products can be uploaded to the UPD.

Inspections

The MEB Agency has taken over veterinary inspections for pharmacovigilance from the Health and Youth Care Inspectorate (IGJ) since January 2019. The VMPU carried out one inspection in 2021. The number remained at one as physical inspections were impossible due to the COVID-19 pandemic.

Assigned centralised CVMP rapporteurships and co-rapporteurships

A total of 16 CVMP rapporteurships and no co-rapporteurships were assigned to the MEB Agency in 2021. The majority of these rapporteurships are part of a bundle of rapporteurships, which explains the high number in 2021.

Assigned centralised rapporteurships and co-rapporteurships

Assigned centralised rapporteurships and co-rapporteurships CVMP
20172018201920202021
Assigned centralised CVMP (co-)rapporteurships254116
Source: EMA Source table as .csv (86 bytes)

Assigned centralised rapporteurships and co-rapporteurships

Assigned centralised rapporteurships and co-rapporteurships CVMP
CountryNumber
Ireland5
United Kingdom0
France6
Spain4
Netherlands6
Germany5
Czech Republic4
Hungary2
Estonia0
Italy0
Austria2
Norway0
Poland1
Portugal1
Sweden2
Denmark1
Finland2
Slovenia0
Slovakia0
Belgium2
Source: MEBa Source table as .csv (323 bytes)

Assigned centralised MRL rapporteurships and co-rapporteurships

An MRL (maximum residue limit) must first be determined for substances that are intended for use in medicinal products for 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 2021.

Assigned centralised rapporteurships and co-rapporteurships

Assigned centralised rapporteurships and co-rapporteurships MRL
20172018201920202021
Assigned centralised MRL (co-)rapporteurships33220
Source: EMA Source table as .csv (84 bytes)

Concluded RMS applications via the mutual recognition and decentralised procedure

The Netherlands concluded 30 DCP applications as a reference member state (RMS) in 2021. This is a decrease compared to the previous year, however the Netherlands has a large share within Europe. Together with Ireland, the Netherlands represented almost half of all DCP and MRP RMS-ships in 2021.

Concluded RMS applications

Concluded RMS applications via the mutual recognition (MRP) and decentralised procedure (DCP)
MRPDCP
2017214
2018214
2019141
2020040
2021030
Source: HMA Source table as .csv (65 bytes)

Concluded RMS applications

Concluded RMS applications via the mutual recognition (MRP) and decentralised procedure (DCP
CountryNumber
Ireland31
United Kingdom0
France15
Spain19
Netherlands30
Germany11
Czech Republic2
Hungary3
Estonia1
Italy1
Austria4
Norway0
Poland2
Portugal6
Sweden0
Denmark0
Finland0
Slovenia0
Slovakia0
Belgium1
Source: EMA Source table as .csv (328 bytes)

Number of marketing authorisations

In contrast to previous years, there was a slight decrease in the number of marketing authorisations for veterinary medicinal products in the Netherlands in the past year.

Number of marketing authorisations

Number of marketing authorisations
20172018201920202021
Number of marketing authorisations22712292232923822349
Source: MEBa Source table as .csv (88 bytes)

Number of withdrawals

There was an increase in the number of withdrawals of marketing authorisations for veterinary medicinal products at the request of the marketing authorisation holder in 2021. This increase is probably related to the new Veterinary Medicinal Products Regulation.

Number of withdrawals

Number of withdrawals
20172018201920202021
Number of withdrawals1091089860139
Source: MEBa Source table as .csv (68 bytes)

Number of concluded cases (including variations)

The number of cases processed by the VMPU in 2021 rose significantly compared to previous years.

Number of concluded cases

Number of concluded cases (including variations)
20172018201920202021
Number of concluded cases (including variations)57646216615756707498
Source: MEBa Source table as .csv (102 bytes)