Article 5(1) of Directive 2001/82 on the Community code relating to veterinary medicinal products, as amended by Regulation No 596/2009, requires no veterinary medicinal product to be placed on the market of a Member State unless an marketing authorisation (MA) has been issued by the competent authorities of that Member State in accordance with that directive. Such a requirement applies even where the medicinal product concerned is already covered by an MA issued by the competent authority of another Member State. That obligation cannot, in principle, constitute a restriction on trade between the Member States prohibited by Article 34 TFEU. The same is true of the other obligations and prohibitions provided for in Directive 2001/82.

Consequently, an operator which has acquired a veterinary medicinal product from a Member State in which it is lawfully marketed under an MA issued by the competent authority of that State cannot, in principle, import that product into another Member State, with a view to its being placed on the market or its administration to animals, since it does not have an MA properly issued in that State.

However, where a veterinary medicinal product covered by an MA granted in accordance with the provisions of Directive 2001/82 in one Member State is imported into another Member State and that import constitutes a parallel import by reference to a veterinary medicinal product already covered by an MA in the Member State of import, the provisions of that directive on the procedure for the grant of an MA do not apply. The authorisation system for parallel imports must nevertheless be examined in the light of the provisions of the FEU Treaty on the free movement of goods.

Member States must, in that case, by a simplified procedure, determine whether the import of a veterinary medicinal product which has an MA in another Member State is a parallel import by reference to a veterinary medicinal product which already has an MA in the Member State of import, since they are obliged to ensure compliance with the obligations and prohibitions laid down in Directive 2001/82. If the veterinary medicinal product concerned must be regarded as having already been authorised in the Member State of importation, the competent authorities of that State must, by a simplified procedure, grant livestock farmers, who wish to import veterinary medicinal products for use on their own farms, a parallel import authorisation, unless that is precluded by considerations relating to the effective protection of human and animal health.

Nonetheless, although, in the event of parallel import of a veterinary medicinal product, the provisions of Directive 2001/82 concerning the procedure for issue of an MA do not apply, that is not the case of the other provisions of that directive. There is nothing to justify the non-application of those stringent provisions, concerning in particular the possession, dispensing, labelling and information leaflet and pharmacovigilance, which form part of the coherent system of measures put into place by that directive in order to ensure a high level of protection of public health, in cases of parallel imports.

(see paras 49-53, 56)