The legislation on falsified medicines imposes obligations on all parties in the pharmaceutical supply chain. Although safety features – the unique identifier (unique serial number and product code) and tamper evidence – do not have to be systematically verified by wholesalers, wholesalers play an important role in verifying the authenticity of medicines packs.
A wholesaler must verify the authenticity of medicines on a risk approached basis. This means the wholesaler must verify the unique identifier of at least those products that are returned to him by pharmacies or other wholesalers. Also products the wholesaler receives from another a wholesaler who is neither the manufacturer nor the wholesaler holding the marketing authorisation nor a wholesaler who is designated by the marketing authorisation holder, must be verified.
The verification of the unique identifier is not required, however, if product ownership changes but the product does not physically move to another location. A verification is also not required when the pack is moving physically within the same country between two locations of the same wholesaler but there is no change of ownership.
EU legislation states that the national competent authorities may require the wholesaler to verify the unique identifier before delivering medicines to certain persons or institutions. E.g. veterinarians, pharmacies, military prisons, dentists and opticians are listed in the legislation.
In Finland the national legislation coming into force 9th February 2019 will state that wholesalers will decommission UI’s when delivering them to veterinarians, the military hospital pharmacy, universities and other research organisations.
Other organisations listed in the delegated regulation buy their medicines from pharmacies, hospital pharmacies and dispensaries in which case they perform the decommissioning.