production criteria

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:

• Veterinary Medicinal Products Regulations (art. 51 - 56)
• Guideline no. 91/412 /EEG (art. 6-14)
• the European Commission’s guidelines for Good Manufacturing Practice for medicinal products (pharmaceutical GMP; art. 50 DGR). These guidelines are used by all EU member states as the standard for the GMP inspections they conduct. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htm

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 DGB).

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 particular 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 other countries.