Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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S.L. 437.47 · Veterinary Medicinal Products (S.L. 437.47)

S.L. 437.47 Art. 73Proofofthecontrol tests which were carried out.

TITLE XI

In KraftAmtlicher Text

(1) The Veterinary Services shall take all appropriate measures to ensure that the marketing authorisation holder and, where appropriate, the holder of the manufacturing authorisation furnish proof of the control tests carried out on the veterinary medical product and, or on the constituents and intermediate products of the manufacturing process, in accordance with the methods laid down for the purposes of marketing authorisation.

(2) For the purposes of implementing subregulation (1), the Veterinary Services may require the marketing authorisation holder for immunological veterinary medicinal products to submit to them copies of all the control reports signed by the qualified person in accordance with regulation 48. The marketing authorisation holder for immunological veterinary medicinal products shall ensure that an adequate number of representative samples of each batch of veterinary medical products is held in stock at least up to the expiry date, and provide samples promptly to the Veterinary Services on request.