The wholesalers play a significant role in securing the supply chain from falsifications
What are the obligations for wholesalers?
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 them by pharmacies or other wholesalers
- 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
- 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 states that wholesalers will decommission unique identifiers 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 the pharmacy performs the decommissioning.
Wholesalers in Finland have committed to checking one pack per each batch they receive. This significantly reduces the risk of false alarms in pharmacies and hospital pharmacies.