Registration of veterinary drugs and animal feed additives

This information is provided by

Netherlands Enterprise Agency, RVO

In the Netherlands, before a veterinary drug may be produced, kept in stock, supplied or administered, you will have to apply for a marketing authorisation to the Medicines Evaluation Board (CBG). Likewise, animal feed additives may only be marketed after such an authorisation by CBG. Animal feed additives are food supplements added to animal feed, such as vitamins, minerals or flavours.

Immunological veterinary drugs

You are not allowed to market a batch of immunological veterinary drugs until after it has been approved by the authorities. You apply to CBG for a batch release certificate of the drugs. However, in order to prevent unacceptable suffering of animals for which they are responsible, veterinarians have the option to treat them with medicines that are not approved in the Netherlands or to apply medicines that are intended for the treatment of other animal species.

Trial dispensation

If you want to conduct trials with veterinary drugs or products not permitted in animal feed, you can apply to CBG for a trial dispensation.

Registration 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.

Reporting adverse events

Once you have a marketing authorisation, you must submit reports of adverse events. You must also make and submit periodic safety update reports (PSUR), either periodically or on request.

This information is provided by

Netherlands Enterprise Agency, RVO