Veterinary medicinal products

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 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.

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.

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 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 concluded cases (including variations)

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