Rules for veterinary drugs and animal feed additives
Do you produce, supply, keep in stock, or administer veterinary drugs in the Netherlands? You must have a marketing authorisation from the Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen, CBG).
Applying for marketing authorisation
Which application procedure and which the marketing authorisation you need depends on the country you want to market the veterinary drug:
- To apply for a marketing authorisation for more EU countries you follow the mutual recognition and decentralised procedure (MRP/DCP)
- To apply for marketing authorisation that is valid throughout the EU you follow the centralised procedure
The European Regulation on Veterinary Medicinal Products is the basis for the different marketing authorisations. You can also find the various application types in the European application form which should be used for all procedures.
A marketing authorisation is valid for an indefinite period. You do not have to renew it. Unless you applied for the marketing authorisation before 28 January 2022. Then it is valid for 5 years. Transitional provisions apply to these. All authorised veterinary medicines in the Netherlands are listed in the Veterinary Medicines Information Bank.
Submit a dossier
To apply for a marketing authorisation, you first must submit a dossier to the Medicine Evaluation Board’s Veterinary Medicinal Products Unit. The contents and layout of the dossier must meet the European requirements. You must also supply information for the Summary of Product Characteristics (SPC), the label, and the package leaflet.
Permission for feed additives
You can only bring animal feed additives to market if you have permission from the European Commission. Additives in animal feed (feed additives) are substances, micro-organisms, or preparations that manufacturers intentionally add to animal feed. For example vitamins and probiotics. You have to submit a dossier with your application for marketing authorisation. Approved feed additives will be listed in the Register of Animal Feed Additives.
Veterinary medicine without market authorisation (cascade)
Are you a veterinarian and are you unable to treat an animal with veterinary drugs approved and/or available in the Netherlands? Then you are allowed use other medicines to prevent unnecessary and unacceptable suffering of animals. This use of medicines outside the terms of marketing authorisation is called cascade. This is a step-by-step plan which tells you how to choose the right medicine.
Immunological veterinary medicines
In the Netherlands, you are not allowed to produce, keep in stock, supply, or administer immunological veterinary drugs until they are approved by the authorities. If you are the holder of marketing authorisation you need to apply for a batch release certificate to the MEB Agency’s Veterinary Medicinal Products Unit.
Registering animal antibiotics
If you are a pharmacist, veterinary surgeon, or someone who keeps animals on a commercial basis, you must report the use of animal antibiotics to a dedicated database (in Dutch). This also applies to cattle farmers with more than 5 fattening pigs, 5 beef cattle, 5 beef calves, or more than 250 poultry or rabbits.
Trial and testing of veterinary drugs
Do you want to conduct clinical trials with veterinary drugs or products that are not permitted in animal feed to test the safety and effectiveness? You can apply for a clinical trial approval to the CBG.
If you want to market animal feed with additives that are not yet authorised, you must first carry out tests in order to examine the animal feed additives. You can apply for permission to carry out tests to the CBG.
Drug monitoring
If you detect adverse effects from your veterinary drugs or animal food additives after marketing authorisation, you must report these to the European pharmacovigilance database (EudraVigilance). The same applies when you discover a product effect. You must also make and submit periodic safety update reports (PSUR), either periodically or on request.