If you supply veterinary medicinal products from the Netherlands to a buyer outside the Netherlands (export), you need a licence for the manufacture, import, wholesale or retail trade in veterinary medicinal products (Art. 4.22 of the Veterinary Medicinal Products Decree).
This part of our website is not up-to-date. The Veterinary Medicines Regulation has been in effect since 28 January 2022. The final national veterinary medicinal products legislation is not published yet. As soon as the final national veterinary medicinal products legislation is published, the Dutch web texts will be updated. Once these are ready, they will be translated into English. This will take some time. Therefore, check our website regularly for any updates.
This also applies to veterinary medicinal products that are not authorised in the EEA but are designated for export to countries outside the EEA after manufacture or import into the EEA. In accordance with GMP guidelines, checks and release must be performed based on a dossier drafted by the importer's Qualified Person. In addition, the manufacturer established outside the EEA must be assessed on GMP requirements by or under the responsibility of the importer's Qualified Person.
At the request of a manufacturer or exporter of a veterinary medicinal product, a certificate shall be issued, showing that a manufacturing licence for the veterinary medicinal product has been granted within the EEA (Art. 4.23 of the Veterinary Medicinal Products Decree). More information about applying for this certificate.
If you supply veterinary medicinal products to buyers abroad, this must be done in accordance with the laws and regulations of the relevant country. For any questions about these laws and regulations, please contact the competent authorities of the country concerned.