In Poland, it is necessary to obtain a special licence to operate a consignment warehouse of medicinal products. This licence authorizes entrepreneurs to store medicinal products and sell them under their own name but on behalf of other entities.

The draft of the Regulation of the Minister of Health on Good Distribution Practice Procedures replaces the regulations from 2002 and introduces some revolutionary changes for many consignment warehouses. Entrepreneurs running them will no longer be able to enter into contracts related to the sale and purchase of medicinal products (§ 8.1 of the Regulation). This regulation comes in the aftermath of the Act which implements Directive 2011/62/EU (relating to falsified medicinal products) in the Polish legal system.

Entrepreneurs wishing to carry out such activities will be obliged to obtain separate wholesale licences for each enterprise. As Polish law does not prohibit the operation of a wholesaler and consignment warehouse in one place, i.e. at the same address, this will allow the costs of reform to be significantly reduced. The only condition is that the storage space of the wholesaler is used only to store the entrepreneur’s own medicinal products and the storage space of the consignment store is used only to store consignments of medicinal products.

The draft regulation has not changed since December 2013, but its final form has not yet been decided.