On 28 December 2015 the Ministry of Human Capacities published a proposal that extensively changes Hungarian pharmaceutical law ("Proposal").
Most notably for pharmaceutical companies, the Proposal amends the rules governing wholesale distribution of medicinal products in Hungary by creating a new category for warehousing and logistics. The new category is called "relocation" during delivery (in Hungarian "átrakás") and will be an exception from the current obligation to hold a license for wholesale activity.
According to the Proposal, relocation would be any activity during the delivery of a product where a third party, under the supervision and responsibility of the wholesaler, loads, unloads and temporarily stores the medicinal products collected and addressed to the buyer without opening them. The Proposal also clearly states that this relocation will not qualify as storage.
According to the Proposal, relocation can be carried out by a contracting party of the wholesaler who does not have a wholesale license. Under the proposed new rules, the relocation must generally be less than 48 hours but may be extended in justifiable cases (although the Proposal does not specify these cases). Under current law, a wholesale license is required for even a relocation that last only a couple of hours.
In addition, the Proposal establishes that the relocation must be carried out at a site where the quality of the medicinal products can be maintained during the relocation.
Another advantage of the Proposal is the possibility of common use of warehouses. Due to the increase of the delivery costs and the developments of the logistical systems, wholesalers demonstrated the need to the legislator that the relocating warehouses used until now only by one wholesaler should be used by the other wholesalers as well. Shared warehouses could enable wholesalers to jointly deliver their various medicinal products more efficiently.
The above changes will be particularly relevant for pharmaceutical companies, where the distribution and warehousing models include cross border shipments and frequent or short time relocations, such as the so called "flash title" model.