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S.L. 437.47 · Veterinary Medicinal Products (S.L. 437.47)

S.L. 437.47 чл. 11AImportation of veterinary medicinal products for food producing animals by veterinary surgeons.

TITLE III

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(1)By way of derogation from regulation 11 (1) and from Article 16(1) of Regulation (EC) No 470/2009, where there is no suitable veterinary medicinal product available either as an authorised product in the Malta or under the provisions of regulation 11(1), veterinary surgeon may, under their direct and only personal responsibility, build up a case and expound it to the

Veterinary Services. Veterinary surgeons shall provide detailed justifications to their request. The Veterinary Services shall and where the disease or condition is such that the veterinary medicinal product is likely to be needed as a matter of urgency for the treatment of an animal, allow the importation of a veterinary medicinal product authorised for any food producing species from any Third country under any conditions it may deem fit, including the assignment of an appropriate withdrawal period, if applicable. The Veterinary Services shall base its decision on purely scientific grounds and shall take all precautions, in particular for the safety and environmental risks which may be associated with the use of the veterinary medicinal product, before granting the approval for the importation, which importation shall be considered as a once only grant with the possibility for repeated requests, with each request considered as sui generis.

(2) The provisions of sub-regulations (6), (7), (8) and (10)of regulations 11 shall apply.

История на изменения
  • Amended by L.N. 179 of 2021