Annual figures for veterinary medicinal products 2015

In the past year, the Veterinary Medicinal Products Unit (VMPU) of the Medicines Evaluation Board Agency (MEB Agency) registered 134 new veterinary medicinal products in the commercial register.

New applications and authorisations

The preliminary figures for applications to the Veterinary Medicinal Products Unit in the period between 1 January 2015 and 31 December 2015 are as follows:

  • 12 applications for new marketing authorisations via the decentralised procedure (MRP/DCP), with the Netherlands acting as the European Reference Member State (RMS).
  • 77 applications for new marketing authorisations via the decentralised procedure (MRP/DCP), with the Netherlands acting as the European Concerned Member State (CMS).
  • In 2015 the VMPU acted as rapporteur for a central application for a new veterinary medicinal product on 4 occasions. The VMPU also acted as a rapporteur for a new application for Maximum Residue Limits on 3 occasions.

The total number of veterinary medicines admitted to the market in the Netherlands as of 31 December 2015 is 2,573 (2014: 2,526).

Export certificates/declarations and batch test certificates

In addition to its activities related to the authorisation of veterinary medicines, the Veterinary Medicinal Products Unit issued 1,643 export certificates/declarations and 1,336 (European) batch test certificates of veterinary vaccines in 2015.

The final figures will be verified and put into context in the 2015 annual report.

* Maximum Residue Limits: an MRL file must be approved for every active substance that is administered to food-producing animals. Withdrawal periods (i.e. the time that must be observed between administration and the time when milk, eggs or meat again becomes suitable for human consumption) are established on the grounds of the defined MRLs.