The MEB Agency’s Veterinary Medicinal Products Unit (VMPU) handles and assesses applications and issues production, distribution and marketing authorisations for veterinary medicinal products. Via the Veterinary Medicines Board (CRD), the VMPU issues a recommendation to the Ministry of Agriculture, Nature and Food Quality (LNV). In the Netherlands, the Minister of LNV is responsible for the marketing authorisation of veterinary medicinal products. On behalf of the Minister of LNV, VMPU is also tasked with monitoring the adverse events of veterinary medicinal products, granting trial exemptions for veterinary medicinal products and feed additives and issuing batch approvals for veterinary vaccines, export certificates and authorisations for wholesale and retail trade.
The Dutch representatives on the Committee for Medicinal Products for Veterinary Use (CVMP) and in the CMDv (Coordination Group for Mutual Recognition and Decentralised Procedures (veterinary)) work within the VMPU.
New regulation on veterinary medicinal products
After a process of over three years, the council working group finalised the text for the new regulation on veterinary medicinal products at the end of December 2017. Based on this text, informal consultations (referred to as the trilogue) will be started on legislative proposals with the European parliament. In the new regulation, the extensive harmonisation of the legislation (Directive 2001/82/EC on veterinary medicinal products and Directive 2001/83/EC on medicinal products for human use) was partially abandoned. The new regulation focuses more on the specific requirements set by the market for veterinary medicinal products. The aims of the new regulation are to reduce the administrative burden, improve the availability of veterinary medicinal products, and allow for better functioning of the internal market in Europe.
The draft includes specific rules for antimicrobial veterinary medicinal products. In terms of public health, the risks of resistance form an important factor in determining the benefit-risk balance. Active substances classified as essential for human health may no longer be used for animals. A regulation is binding for all Member States. There is less room for national interpretation or additional criteria.
Members of the Veterinary Medicines Board (CRD) in 2017
Dr D.G. Groothuis, Chair (up to the end of October 2017)
Drs M.H.C. Ambagts
Dr R. Bouwstra
Dr E.M. Broens
Dr D.C.K. van Doorn
Dr H.P.M. Vijverberg, Chair as of November 2017
Drs N. Wijne-Raemakers
An overview of several important figures for veterinary medicinal products is provided below. This is not a comprehensive overview of all activities falling under veterinary medicinal products.
Veterinary medicinal products with a new active substance authorised via the Centralised procedure
|New active substance - Centralised procedure|
See Appendix B for the list of active substances in 2017.
In total there were 38 Centralised procedures, in 10 cases the Netherlands was involved as (co) rapporteur.
For 2 applications, the Netherlands was (co) rapporteur for new maximum residue limits.
New applications via the Decentralised procedure
|DCP RMS||DCP CMS|
In 2017, the number of DCPs for RMS applications has remained the same and has increased for CMS applications.
New applications via the Mutual recognition procedure (MRP)
The long-term number of new applications via the mutual recognition procedure (MRP) consists primarily of CMS applications. They decreased slightly last year. There were no RMS applications via the MRP in 2017.
Authorised veterinary medicinal products
|Authorised veterinary medicinal products|
The number of authorised veterinary medicinal products has almost remained the same in 2017. The number of new marketing authorisations issued is 111.