Reimbursement of packs that can’t be dispensed to the patient

For reimbursement of packs that can’t be dispensed to the patient because of the Belgian SOP for Alert Handling the same procedures should be followed as for a pack that shows a quality defect.

• In case the pharmacist, hospital or wholesaler bought an already decommissioned pack from the MAH, the MAH should reimburse the pack.
• In case the pharmacist or hospital bought an already decommissioned pack from the wholesaler, the wholesaler should reimburse the pack.
• In case the MAH requests that a pack should be destroyed or returned because he cannot upload correctly the pack in the EU-Hub the MAH should reimburse the pack.
• In case the end-user can’t guarantee the authenticity of the pack, and he didn’t buy the pack directly from the wholesaler or MAH, the end-user will bear the costs of the pack.
• In case of a falsification the entity who brought the pack into the supply chain will assume the costs.