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.
