distribution criteria

License criteria have been set for storage and delivery to ensure that the quality of the veterinary medicinal product, as guaranteed by the product manufacturer, is safeguarded in the distribution channel as well, and that no danger to the health of people, animals or the environment can arise during the delivery of the veterinary medicinal product.

The license criteria concern the design and use of the location for the storage and/or delivery of veterinary medicinal products, the technical equipment and the manner of organising the administration (art. 23 DGW).

Before a license can be issued or changed, an assessment is conducted on site (inspection). This is not necessary if the application for a change refers exclusively to administrative data or the proposed change occurs in the same locations (art. 46 DGR).

After an appointment is made for an on-site inspection, the criteria for a license for the delivery of veterinary medicinal products are sent to the applicant (art. 57 – 59c DGR).

Recall (art. 30 DGB)

If the holder of a distribution license decides to suspend or restrict delivery of a veterinary medicinal product, and this decision involves:

1. the efficacy of a veterinary medicinal product;
2. the protection of public health

then the Minister (the Veterinary Medicines Board) should be informed of this decision immediately along with the reasons for doing so. In such cases the ultimate destination of the veterinary medicinal products is indicated.

If the decision involves the protection of public health, then the Minister of Health, Welfare and Sport should also be informed.