Veterinary medicinal products for animals

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 committee convenes every month at the EMA in Amsterdam.

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 convenes, just as the other committees, 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 animal feed were adopted on 11 December 2018. These regulations will come into force on 28 January 2022. Until then, a lot of time and attention is required to build a European product database. The work processes and ICT infrastructure will also have to be adapted to the regulation. In close cooperation with the Ministry of LNV, the BD is working on the European level to ensure a smooth implementation. BD staff provide support to the Ministry of LNV in the process of formulating secondary legislation in the form of delegated and implementing acts. The Ministry of LNV has made an additional budget available for this of € 500,000 during a three-year period. With this extra budget, the BD is able to play a role with regard to crucial points in the European development process of the various changes, such as an efficient European product database.

Inspections

The MEB has taken over veterinary inspections for pharmacovigilance from the Health and Youth Care Inspectorate (IGJ) since January 2019. Two inspections were carried out by the BD in 2019.

Assigned CVMP centralised rapporteurships and co-rapporteurships

Four CVMP rapporteurships and co-rapporteurships were assigned to the MEB in 2019.

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. This is the time between treatment of an animal and the time at which the meat, milk and eggs are suitable again for human consumption as the residues of the veterinary medicinal product have disappeared from the food products. The rapporteur of an MRL application assesses the maximum safe concentration of the residue of an active substance in the various consumable products of animal origin.

Two MRL rapporteurships or co-rapporteurships were assigned to the MEB in 2019 compared to three in the previous years.

Concluded RMS applications via the mutual recognition and decentralised procedure

After Ireland, the BD coordinated most of the procedures in which we had the lead (RMS). As RMS, the Netherlands concluded nearly three times as many veterinary registrations in 2019 as in 2018. Part of this increase is due to taking over RMS-ships from the United Kingdom in connection with Brexit. In addition to the 42 times that the Netherlands was the RMS for a procedure, the MEB also acted 60 times as concerned member state (CMS) for a new application via the mutual recognition and decentralised procedure.

Number of marketing authorisations

After a minimal decrease in 2017, the number of marketing authorisations for veterinary medicinal products authorised in the Netherlands increased slightly in 2018 and 2019.

Number of concluded cases (including variations)

The number of concluded cases remained practically the same as in previous years.

Withdrawals

The number of withdrawals for veterinary medicinal products was slightly lower in 2019 than compared to the previous two years.