S.L. 437.115 Art. 14Products in transit.

(1) When veterinary medicinal products are in transit for the sole purpose of export and without them being placed on the European Union market, the provisions of Article 88 of Regulation

(EU) 2019/6 shall apply, even though the product remains intact and no manufacturing activities are carried out:

Provided that such products may be exempted from the provisions of Article 88 of Regulation (EU) 2019/6 when the transit is for the sole purpose of re-export, is affected within the freeport, free trade zones or customs tax warehouses. However, in such instances the wholesale distribution authorisation provided for in Article 99 of Regulation (EU) 2019/6 shall nonetheless be required by the company engaging in the process.

(2) In cases where manufacturing activity in relation to the products in transit for the sole purpose of export is carried out, the manufacturing authorisation provided for in Article 88 of Regulation

(EU) 2019/6 shall be required, even if the operations are affected within the freeport, free trade zones or customs tax warehouses.

(3) The veterinary medicinal products which are in transit for the sole purpose of export which qualify for the exemption provided for in this regulation may be also exempted from the provisions of Article 5 of Regulation (EU) 2019/6.

(4) The Director shall be notified by the wholesale distributor in the manner indicated by the Director if such an activity is ever conducted.