S.L. 437.47 Art. 63Administration of small quantities of readymade veterinary medicinal products.

By way of derogation from regulation 9 and without prejudice to regulation 60, Malta shall ensure that veterinarian surgeons providing services in another Member State can take with them and administer to animals small quantities of veterinary medicinal products not exceeding daily requirements other than immunological veterinary medicinal products which are not authorised for use in the Member State in which the services are provided, provided that the following conditions are satisfied:

(a) the authorisation to place the product on the market provided for in regulations 5, 7 and 8 has been issued by the competent authority of the Member State in which the veterinary surgeon is established;

(b) the veterinary medicinal products are transported by the veterinary surgeon in the original manufacturer’s packaging;

(c) the veterinary medicinal products intended for administration to food-producing animals have the same qualitative and quantitative composition in terms of active substances as the medicinal products authorised in accordance with regulations 5, 7 and 8 in the host Member State;

(d) the veterinary surgeon providing services in another Member State acquaints himself with the good veterinary practices applied in that State and ensures that the withdrawal period specified on the labelling of the veterinary medicinal product concerned is complied with, unless he could reasonably be expected to know that a longer withdrawal period should be specified to comply with these good veterinary practices;

(e) the veterinary surgeon shall not furnish any veterinary medicinal product to the owner or keeper of the animals treated in the host Member State unless this is permissible on the basis of the rules of the host Member State; in this case he shall, however, supply only in relation to animals under his care and only the minimum quantities of veterinary medicinal product necessary to complete the treatment of animals concerned on that occasion;

(f) the veterinary surgeon shall be required to keep detailed records of the animals treated, the diagnosis, the veterinary medicinal products administered, the dosage administered, the duration of treatment and the withdrawal period applied. These records shall be available for inspection by the competent authority of the host Member State for a period of at least three years;

(g) the overall range and quantity of veterinary medicinal products carried by the veterinary surgeon shall not exceed that generally required for the daily needs of good veterinary practice.