Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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S.L. 437.115 · Veterinary Medicinal Products (S.L. 437.115)

S.L. 437.115 Art. 16Dispensing.

In KraftAmtlicher Text

(1) Veterinary medicinal products may only be dispensed from the premises and persons provided for in regulation 18.

(2) A veterinary surgeon may dispense veterinary medicinal products during his professional visits or when clients visit him:

Provided that the veterinary surgeon shall supply the quantities of veterinary medicinal products only for treatments to animals under his care. If the type of the packaging is such that the veterinary surgeon cannot supply lesser quantities thereof, the veterinary surgeon may supply the animal owner and, or the keeper and, or the carer with the quantities needed for the full treatment of the condition.

(3) In any doubtful situation and within the limits of his responsibilities, when dispensing veterinary medicinal products, the dispenser shall be satisfied that the person who will use the product is competent to do so safely and intends to use it for a purpose for which it is authorised or indicated by the veterinary surgeon.

(4) When dispensing veterinary medicinal product, the dispenser shall advise the receiver of the product on the dosing, safe administration of the product and on any warnings or contra-indications on the label or package leaflet, including information on any applicable withdrawal periods.

(5) The dispenser shall provide to the Director any information about veterinary medicinal products, including data on sales and use of veterinary medicinal products upon his request.

(6) When dispensing veterinary medicinal products and medicinal products for human use containing antimicrobials, the dispenser shall be satisfied that all necessary precautions have been taken to minimise the risks of antimicrobial resistance, in particular the use of critically important antimicrobials.

(7) If the dispenser is not the veterinary surgeon issuing the veterinary prescription and the dispenser has concerns about the veterinary prescription presented to him, he shall resolve them with the prescribing veterinary surgeon before dispensing the product.

(8) If a veterinary medicinal product is supplied in a container other than that specified in the marketing authorisation, the dispenser shall ensure that the container is suitably labelled and shall supply sufficient written information.

(9) The dispenser shall be present when a veterinary medicinal product is dispensed unless:

(a) each transaction is authorised individually before the product is supplied; and

(b) the dispenser is satisfied that the person dispensing it over is competent to do so.

(10) The Director may request the dispenser to provide any samples of the veterinary medicinal products.