Technically the repackaging use case by a parallel distributor is covered by the above mentioned use cases “decommission pack” and “upload product pack data”. This section describes how both use cases are used in order to support the repackaging process.

The parallel distributor unpacks the original product packs (supported by decommission pack use case), produces repacked product packs and marks them with a Data Matrix code. The information about the original product code and batch used for repackaging and the new product code and batch for the repacked product packs is then transmitted from the parallel distributor system to the European Hub (supported by upload product pack data use case).

For a pair of product code and batch ID, a “For Repack” Buffer contains the quantity information about how many doses of this product / batch have been decommissioned for repackaging by the parallel distributor. This quantity information is reduced by the number of doses that has been transmitted as repacked product to the European Hub. The conversion from number of packs to number of doses is done based on the information contained in the applicable product master data set.

Note that a link between the original product batch information and the parallel distributor undertaking the repackaging activity is needed in the Recall Batch use case in order to figure out those parallel distributors that might be affected by a recall of an original manufacturer batch. The list of serial numbers decommissioned and new serial numbers created for a given repack operation is also maintained within the given buffer (ref Art 34(4) of Commission Delegated Regulation (EU) 2016/161 of 9th February 2016.

Once the decommissioning of all product packs is completed, the national system transmits the set of repack results together with the corresponding serial numbers to the European Hub that receives it. The European hub stores the batch number and the information about the quantity of doses whose status has been set to “Checked-Out” in a “For Repack” buffer. This enables the European hub to maintain accurate figures about the original product quantities that will be used in a repackaging activity – for later reconciliation with the quantity of repacked product.

For further clarification on this article please feel free to see the document EMVO_0020_EMVS Requirements URS Lite or contact the EMVO Helpdesk.

Email: helpdesk@emvo-medicines.eu