The Veterinary Medicinal Products Unit, coordinates the applications for marketing authorisation for veterinary medicines and requests evaluations 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:
- 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 or for which marketing authorisation has been requested.
- Mutual recognition and Decentralised procedure (MRP/DCP). European procedures for applying for marketing authorisation based on the recognition of the evaluation conducted by a Member State of the European Union (EU), by the so-called Reference Member State (RMS).
- Centralised procedure. An application for marketing authorisation throughout the entire EU. The evaluation is carried out by the European Medicines Agency (EMA).
Along with the above-mentioned application procedures, there is a choice of eight different application types, derived from the European Directives 2001/82/EC and 1234/2008/EC. These application types are also specified in the European application form that must be used for all procedures.
- Directive 2001/82/EC, 6 November 2001
- Regulation (EC) no. 1234/2008, 24 November 2008
- Notice to Applicants - Volume 6B, Part 1A Summary of the dossier - Application form
The Notice to Applicants specifies all requirements for the preparation and submission of the dossier. This website also contains the veterinary guidelines.
- EudraLex - Volume 6 Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use
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 (CRD). The CRD 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.