Application via the centralised procedure
Veterinary medicinal products that follow a centralised procedure and are positively assessed receive a marketing authorisation that is valid throughout the European Union. This marketing authorisation is issued under the responsibility of the European Commission.
The centralised procedure is mandatory for products based on new active substances, cell therapy and novel therapies. For all other products, a company can choose whether it wants to use the centralised procedure. This also applies, for example, to generics of nationally authorised veterinary medicinal products.
Article 42 of the Veterinary Medicinal Products Regulation describes the full scope of the centralised authorisation.
The application of a veterinary medicinal product must be submitted to the European Medicines Agency (EMA). Applicants can obtain advice in advance from the EMA with regard to preparing the dossier. The EMA's Committee for Medicinal Products for Veterinary Use (CVMP) assesses the extent of efficacy/damage of the submitted veterinary medicinal product. The CVMP has 210 days at most to come to a final decision. This period may be interrupted to give the company the opportunity to answer questions. It is also possible for a company to provide a verbal clarification of the submitted dossier.
The CVMP's final conclusion is sent to the European Commission for a definite decision. Normally, the European Commission agrees completely with the CVMP's conclusion. If the resolution is positive, the Summary of Product Characteristics (SPC), label and package leaflet are set. The issuing of European authorisations is documented in a European Register for Veterinary Medicinal Products.
The SPCs of centrally authorised veterinary medicinal products can be found with the associated European Public Assessment Report (EPAR) on the EMA website. If the resolution is negative, the rationale for this decision is explained. The centrally authorised veterinary medicinal products are given a European registration number.
EMA – CVMP
The CVMP meets in Amsterdam. Each European Member State has one representative on the CVMP and one alternate. In the CVMP two rapporteurs are assigned to each centralised application, who follow the product throughout its lifecycle. The CVMP members function under personal titles. They have a bridging function between European and national legislation and playing fields.
In the Netherlands, the Dutch CVMP member is accountable to the Veterinary Medicinal Products Unit (VMPU), and to the Ministry of Economic Affairs. The CVMP is supported by a number of permanent working groups and ad-hoc working groups. The Netherlands is in principle represented in all working groups.
Besides the centralised applications, the CVMP plays an important advisory role in the objection procedures arising from the mutual recognition and decentralised procedures. The CVMP also takes on objection procedures that are initiated when the protection of public health is concerned or another European interest is involved. For these objection procedures as well, the CVMP produces an advisory report for the European Commission, which then takes the binding decision.
Another key task of the CVMP is determining the Maximum Residu Limit (MRL) for active ingredients that can end up in the food chain (such as milk, eggs, meat and honey), before they can be authorised for use as veterinary medicinal products intended for food-producing animals. The CVMP also supports applicants in the research and development of new veterinary medicinal products. In addition, the CVMP prepares scientific guidelines and regulations. It also works together with international partners on the harmonisation of regulations for veterinary medicinal products. All veterinary guidelines, regulations and set MRLs can be found on the EMA website.
For general and procedural questions about the centralised procedure, please contact the Veterinary Medicinal Products Unit.