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Wholesaler: Definition and Product Validation Process
Wholesaler: Definition and Product Validation Process
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Written by Tracy Slosse
Updated over a week ago

The definition of a wholesaler is the following:

A wholesaler can:

(a) Hold a marketing authorisation,

(b) Be designated by the marketing authorisation holder (by means of a written contract) to store and distribute the products covered by his marketing authorisation on his behalf.

In Art. 20, two categories of medicines are identified for which the wholesaler has to verify the unique identifier:

  1. Medicinal products returned to him (a) by persons authorised or entitled to supply medicinal products to the public (b) by another wholesaler

  2. Medicinal products he receives from a wholesaler who is (a) neither the manufacturer (b) nor the wholesaler holding the marketing authorization (c) nor a wholesaler who is designated by the marketing authorisation holder (by means of a written contract) - to store and distribute the products covered by his marketing authorisation on his behalf.

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