Veterinary medicinal products

European committees

The Committee for Medicinal Products for Veterinary Use (CVMP) is the scientific committee for veterinary medicines 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 has been delegated to 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 and is also supported by the EMA. The Dutch representatives in both the CVMP and the CMDv work at the BD.

New European legislation

The Regulation on veterinary medicinal products and the Regulation on medicated feed were adopted on 11 December 2018. These regulations will come into force on 28 January 2022. Due to COVID-19, the process of drafting the secondary legislation (referred to as delegated and implementing acts) was stalled for several months. The European Commission took this up again in September 2020 and a lot of work has been done since then to catch up with the backlog. The EMA also started developing the European product database. From 28 January 2022, this will include all veterinary medicines authorised in the EU. This Union Product Database (UPD) will be the source of information on veterinary medicines for veterinarians and the public, and will also become the source file for EVvet3, the new European database of adverse reactions to veterinary medicines. In close cooperation with the Ministry of LNV, the BD is working on the European level to ensure a smooth implementation. BD staff support the Ministry of LNV in the secondary legislation process, and the amendment of Dutch legislation, such as the Animals Act and underlying decrees and regulations. The Ministry of LNV has made an additional budget available for this. Thanks to this additional budget, the BD is able to play a role at crucial points in various European development processes, such as an efficient European product database.

Inspections

The MEBa has taken over veterinary inspections for pharmacovigilance from the Health and Youth Care Inspectorate (IGJ) since January 2019. In 2020, the BD carried out one inspection, which was completed in full.

Assigned centralised CVMP rapporteurships and co-rapporteurships

One CVMP rapporteurship or co-rapporteurship was assigned to the MEBa in 2020. It should be noted that this procedure was withdrawn by the applicant before it started. Compared to 2019, there were significantly fewer rapporteurships and co-rapporteurships to be distributed in the CVMP in 2020 (13 in 2020 compared to 21 in 2019).

Assigned centralised MRL rapporteurships and co-rapporteurships

A MRL (maximum residue limit) must first be determined for substances that are intended for use in medicinal products for food-producing animals. This is the time between treatment of an animal and the time at which the meat, milk and eggs are suitable for human consumption again as the residues of the veterinary medicine have disappeared from the food products. 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.

As in the previous year, two MRL rapporteurships or co-rapporteurships were assigned to the MEBa in 2020.

Concluded RMS applications via the mutual recognition and decentralised procedure

The BD coordinated the most procedures in Europe as a reference member state (RMS) in 2020. The Netherlands concluded 40 DCP applications as the RMS, representing almost a quarter of all DCP and MRP RMS-ships. Over 60% of the RMS-ships were divided between the Netherlands, Spain and Ireland. No mutual recognition procedures were concluded with the Netherlands as the RMS in 2020.

Number of marketing authorisations

Compared to previous years, there was again a slight increase in the number of marketing authorisations for veterinary medicines in the Netherlands in the past year.

Number of withdrawals

In 2020, fewer marketing authorisations for veterinary medicines were withdrawn at the manufacturer’s request than in previous years.

Number of concluded cases (including variations)

The number of cases processed by the BD in 2020 decreased slightly compared to 2018 and 2019.