End users and FMD activity

As from 9 FEB 2019 the execution of the rules defined for the end users in the Delegated Regulation becomes mandatory. Falsified Medicines Directive article 118a clearly states that end users who are not compliant to the directive can be subject to penalties imposed by the relevant national authorities.

Obligations of the end users:

                Wholesalers
                Pharmacies (Public & Hospital)

 Wholesalers

The general principle for wholesalers is a risk based verification. This means that the wholesaler needs to verify the pack code where a falsification risk can be assumed.
More specifically this is the case when he receives a pack

  • returned to him from the pharmacy or hospital (or other client)
  • from another wholesaler who is not the manufacturer/MAH or a wholesaler acting on behalf of the manufacturer/MAH

The wholesaler also needs to decommission the pack when

  • the pack is exported outside the EU
  • the pack is returned to him (by pharmacy, …) and he cannot take the pack back into the saleable stock
  • the pack is intended for destruction
  • the pack is provided to the authorities as a sample
  • the pack is sold to persons or institutions which are outside the traditional supply chain

If the result of the verification indicates that the pack has no longer the status “active”, the wholesaler must keep the pack aside and wait for confirmation, after investigation, if the pack is to be considered as a falsification.

The different transactions the wholesaler can submit to the verification system are listed in the Distribution activity table.

Access to the repository system

To get access to the repository system, the wholesaler must be registered. Only companies with a wholesale license can receive access to the verification repository.
The acknowledgement as a Wholesaler by the BeMVO will be done based on the WDA list from EUDRA GMDP for Belgium.
Luxembourg wholesalers will be assessed by the LMVO.

Pharmacies

The public pharmacy must verify the pack at the moment when the pack is supplied to the public. The pharmacy can also scan and verify the pack earlier, eg at reception, but anyhow a verification and especially the decommissioning of the pack must be done at the moment of delivery.

The Delegated Regulation has foreseen an exception for the hospital pharmacy. The hospital pharmacy can verify and decommission the pack at any moment when the pack is in his possession, so also when receiving the pack, provided that after the decommissioning the pack is supplied within the hospital.

The pharmacy also needs to verify and decommission the pack when

  • the pack cannot be returned to the wholesaler or manufacturer
  • the pack is provided to the authorities as a sample
  • the pack is subsequently used as authorized investigational medicinal product or as authorized auxiliary medicinal product [EU Regulation 536/2014, 2(2),(9) and (10)]

The pharmacy is exempted from the verification and decommissioning if the product is provided to him as a free sample. But the pharmacy has to verify the anti-tampering device of the sample.
A hospital pharmacy can also be exempted if the decommissioning was done by a wholesaler who belongs to the same legal entity as the hospital, there was no sale between the wholesaler and the hospital and the product is supplied within the hospital.

In case the pharmacy is only supplying part of the pack, the verification and decommissioning must be done at the moment when the pack is opened for the first time. If the opening of the pack is done by an external actor (eg IMV preparation), the pharmacist remains responsible for the verification and decommissioning of the pack.

If the pharmacy has a technical problem and cannot connect directly with his system to the verification database, then the pharmacy has 2 options

  • he can use the web interface in his web browser and enter the codes manually for verification and decommissioning
  • if not, he must store the codes in his system and submit the codes for verification and decommissioning as soon as his system is again connected to the verification database

If the result of the verification indicates that the pack has no longer the status “active”, the pharmacy must keep the pack aside and wait for confirmation, after investigation, if the pack is to be considered as a falsification.

The different transactions a pharmacy can submit to the verification system are listed in the Distribution activity table.

Access to the repository system

To get access to the repository system, the pharmacy must be registered.
The acknowledgement as a Public Pharmacy by the BeMVO will be based on the FAGG/AFMPS list of pharmacies for Belgium. Important to make sure the information is up to date.
The acknowledgement for hospital pharmacies will be based on the list of hospitals published by RIZIV/INAMI.
Luxembourg pharmacies and hospitals will be assessed by the LMVO.

Distribution activity table.

Distribution Acitvity Table