With respect to import of medicinal products from third countries, such activity may only be carried out by a person who has obtained an authorisation to manufacture medicinal products in the scope of import from third countries (hereinafter referred to as the “importer”). A distributor will no longer be able to carry out import of medicinal products from third countries, without being the holder of manufacturing authorisation in the scope of import from third countries.
The following approaches may be applied to import from third countries:
a) The import is conducted solely by the importer of medicinal products who carries out the receipt, storage and certification of the imported batch;
b) The import is conducted by the importer with the involvement of its contracted manufacturing sites. These contracted sites arrange for the receipt and storage of the imported batch prior to certification by the importer's qualified person.
In compliance with good manufacturing practice, a manufacturing relationship has to be contracted between the importer of the medicinal product and the contracted manufacturer to cover the area of storage of the batch originating in a third country and not yet released by the importer’s qualified person. In these cases the manufacturing process has not been completed as yet and the batches manufactured in a third country are hence not released by the qualified person of the importer in the EU. For this reason it has to be stored in a quarantined manufacturing warehouse. Distributors of medicinal products do not have manufacturing warehouses (herein in terms of the storage of a batch for which the manufacturing process has not yet been completed), unless they have obtained manufacturing authorisation in the scope of import from third countries.