According to the Directive 2011/62/EU (FMD) and the Delegated Regulation (EU) 2016/161, the Marketing Authorisation Holder (MAH) or the person responsible for placing those medicinal products on the market shall not upload Unique Identifiers (UIs) in the repositories system before having removed from therein, where present, older Unique Identifiers (UIs) containing the same product code and serial number as the Unique Identifiers (UIs) being uploaded (Article 42, Delegated Regulation (EU) 2016/161).

To comply with this obligation, Parallel Distributors (PDs) have to pair the original product code and batch ID with the new ones. Whenever a Parallel Distributor repackages an original product and puts a new Data Matrix code on a new pack, this pairing is necessary, therefore the 'for repack buffer' has been implemented.

A 'for repack buffer' contains the quantity information about how many doses of a product / batch have been decommissioned for repackaging by a parallel distributor.

There is no requirement for 1:1 serial number reconciliation, only that eventually, the list of serial numbers from the inbound 'decommissioning' activity can be linked with the list of serial numbers created on the outbound 'transmit Product Packs Data' activity. Taking the input information and the information from the product master data about the number of doses per pack, the system updates the 'for repack buffer'.

For further clarification on this article please feel free to contact the EMVO Service Desk at helpdesk@emvo-medicines.eu