After an application is submitted for a production license
(covering the actions of preparation, packing, labelling
and/or release for the market), the Veterinary Medicines Board will
advise the Health Care Inspectorate (IGZ) about how well your
organisation meets the relevant criteria.
The specified criteria for the production of veterinary
medicinal products are described in:
For information, a
summary of the GMP guidelines has been prepared.
The holder of a production license is forbidden to prepare,
package, label or deliver a veterinary medicinal product without
taking into account the specified criteria (art. 27 DGB).
The license holder should carry out the production actions in
agreement with the data on which the marketing authorisation of the
veterinary medicinal product was granted (art. 28
Import of veterinary medicinal products
A license for the import of a veterinary medicinal product is
equivalent to a permit for the preparation of that veterinary
medicinal product (art. 85 DGB).
Without a license for the preparation of that veterinary
medicinal product, it is forbidden to release a veterinary
medicinal product originating from a third country (situated
outside the EU, incl. Iceland and Norway) for free circulation
in the Netherlands (art. 43 DGB).
The same applies to supplying a buyer in another member state
with a veterinary medicinal product, originating from a third
country, that has been released for free circulation in the
Netherlands (art. 44 DGB).
Those who release veterinary medicinal products originating from
a third country for free circulation in the Netherlands meet
criteria for the preparation of a veterinary medicinal product
(art. 60, 61 DGR).
The criteria depend on the origin of the veterinary medicinal
product (the country where the veterinary medicinal product is
produced). Special criteria currently apply to the import from
countries with which the EU has signed a mutual recognition
agreement (Australia, New Zealand, Switzerland and Canada) and