The MEB Agency, Veterinary Medicinal Products Unit (VMPU) takes care of the handling and assessment of applications and issuing of production and distribution licenses and marketing authorisations for veterinary medicinal products.
During the handling of applications for production and distribution licenses and marketing authorisation for both the Dutch as the European market, the Veterinary Medicinal Products Unit takes care of the administrative assistance, the progress and communication during the procedures, and consistency. The Veterinary Medicinal Products Unit also does the pharmacovigilance after granting a marketing authorisation.
According to article 1 of the Animals Act (Wet dieren), a veterinary medicinal product is any composition of single or compound substances that:
- is presented in any form as having therapeutic or prophylactic properties relating to animal diseases, or,
- can be applied to animals to recover, improve or change physiological functions by achieving a pharmacological, immunological or metabolic effect, or, can make a medical diagnosis.
The definition of a veterinary medicinal product is based on the substance and the intended use of the substance, with or without revision or processing. This intended use can be indicated on the label or via another claim that the seller has attributed to the product. The use on animals of substances that clearly display a certain pharmacological effect also falls under the designation as veterinary medicinal product.
Homeopathic veterinary medicinal products also fall under the Animals Act (Wet dieren). There are however a number of additional categories of veterinary medicinal products that are exempted from the obligation for registration. These exceptions are described in article 3.16 – 3.23 of the Decree on veterinary medicinal products contains exemptions or dispensations from the ban – defined in article 2.19, section 1 of the act – concerning the marketing of a veterinary medicinal product without the required license. Article 3.6 – 3.12 of the Regulation on veterinary medicinal products further expands on the abovementioned stipulations.
If you have any questions, for example about whether a veterinary medicinal product falls under the abovementioned exemption and meets the set requirements, then you can send these questions to the MEB Agency, Veterinary Medicinal Products Unit.
In addition to these primary tasks, the Veterinary Medicinal Products Unit also performs various tasks related to veterinary medicinal products. These include, for example, the administrative supervision of applications for additives for use in animal nutrition (and test exemptions); batch inspections and declarations; adverse events; pharmacovigilance and PSURs and the evaluation and awarding of licenses for the manufacture and distributions of veterinary medicinal products.