The Veterinary Medicinal Products Unit coordinates the applications for marketing authorisation for veterinary medicines and requests assessments from internal experts and specialist institutes on the basis of the accompanying dossier. When assessing veterinary medicinal products, the quality, safety and efficacy of the veterinary medicinal product are key aspects.
A marketing authorisation can be applied for in several ways:
Centralised procedure. An application for marketing authorisation throughout the entire EU. The assessment is carried out by the European Medicines Agency (EMA).
Mutual recognition and Decentralised procedure (MRP/DCP). European procedures for applying for marketing authorisation based on the recognition of the assessment conducted by a Member State of the European Union (EU), by the so-called Reference Member State (RMS).
National procedure. An application for marketing authorisation restricted to the Netherlands. This applies only to :
- veterinary medicinal products which are not authorised in one of the EU Member States
- veterinary medicinal products for which no marketing authorisation has been requested in one of the EU Member States.
Along with the above-mentioned application procedures, there is a choice of different application types. These application types can result in different kinds of marketing authorisation, for which the Veterinary Medicinal Product Regulation is the basis. The application types are also stated in the European application form which should be used for all procedures. More information is available on the page Types of marketing authorisation.
Reporting, advice and assessment
The Veterinary Medicinal Products Unit reports every application for marketing authorisation for a veterinary medicinal product (except for applications received via the Centralised procedure) to the Council for Animal Matters (Ctd). The Ctd then advises the Minister of Economic Affairs and the Minister of Public Health, Welfare and Sport about granting the marketing authorisation.
A marketing authorisation can be granted if it is clear from the data that:
- the assessment of benefits and risks of the veterinary medicinal product is favourable
- the veterinary medicinal product has the claimed therapeutic effect
- the veterinary medicinal product has the specified qualitative and quantitative composition
- the data submitted with the application are in line with the supportive legislation.
Granting of marketing authorisation
If a marketing authorisation can be granted, the applicant is sent a resolution with the appropriate marketing authorisation number (REG NL number), the Summary of Product Characteristics (SPC), the labelling and the package leaflet text. Veterinary medicinal products authorised via the centralised procedure are given a European marketing authorisation number.
The SPC is the scientific text containig all important data for the product. The labelling and the package leaflet are derived from this text. The applicant submits proposals of draft texts, but the VMPU determines their final version. For the text of the SPC, please use the NL SPC-template, see SPC, labelling and package leaflet.
In the Veterinary Medicinal Products Data Bank, you can find an overview of all veterinary medicinal products which have a marketing authorisation in the Netherlands.
As a marketing authorisation holder, following the granting of marketing authorisation you can change, withdraw or transfer the marketing authorisation.
Do you have any additional question about an application procedure? Please contact the Veterinary Medicinal Products Unit.