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Registration of veterinary drugs and animal feed additives

This information is provided by:Netherlands Enterprise Agency, RVONetherlands Enterprise Agency, RVONederlandse versie

Do you produce, keep in stock, or administer veterinary drugs in the Netherlands? You first will have to apply for a marketing authorisation to the Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen, CBG). Likewise, animal feed additives may only be marketed after such an authorisation by CBG.

Registering veterinary drugs

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 with a batch release certificate. Veterinary drugs must always be assessed for effectiveness, safety, and pharmaceutical quality. You can apply for a batch release certificate to CBG.

Exemption batch release certificate (cascade)

Are you, as a veterinary, unable to treat an animal or its condition with approved veterinary drugs? Then you may use medicines that are not (yet) approved in the Netherlands or medicines that are intended for the treatment of other animal species. This use of medicines outside the terms of marketing authorisation is called cascade. You can use cascade to prevent unacceptable suffering of animals that you are responsible for.

Registering animal additives

Do you want to market animal feed additives? For example, food supplements that are added to animal feed, such as vitamins, minerals, or flavours. Then you have to apply for marketing authorisation to the European Commission.

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.

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.

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.

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