S.L. 437.115 Art. 28Other medicinal products.

(1) Without prejudice to any provision of these regulations, the Director may establish additional requirements for the wholesale distribution of the following veterinary medicinal products and publish them in the Gazette:

(a) veterinary medicinal products containing strong sedatives, narcotic drugs or psychotropic drugs;

(b) veterinary medicinal products used for euthanasia;

(c) veterinary medicinal products derived from blood;

(d) immunological veterinary medicinal products;

(e) such other veterinary medicinal products or class or classes of veterinary medicinal products as the Minister may prescribe; and

(f) veterinary medicinal products containing antimicrobials, in particular those that are deemed critical for human health.

(2) Without prejudice to any provision of these regulations, the Director shall take the necessary measures in order to prevent veterinary medicinal products that are introduced into the European Union but which are not intended to be placed on the market of the European Union from entering into circulation if there are sufficient grounds to suspect that those products are falsified. These measures shall include the application of these regulations to warehouses situated in the free port, free trade zones or customs tax warehouses authorized to store veterinary medicinal products. These measures may be issued in the Gazette through a notice.

(3) When the Director has valid reason to believe that circumstances may exist which would render necessary the consideration of whether the wholesale distribution authorisation should be varied, suspended or revoked, the Director may serve the holder a notice requiring him, within such period as may be specified in the notice, to provide any information specified in the notice.