Getting the distribution channel ready for FMD serialization compliance is one of the paths to successfully comply with its requirements for the upcoming year.
Is the distribution channel ready for Serialization?
There is no doubt that serialization has been definitely a challenge for the Pharma industry during this year. With less than half a year left for the European Union’s Falsified Medicine Directive to come into place, just 160 companies have been passed the last stage of the EMVO’s technical on-boarding step and finally complying to the requirements of the EU’s Production Environment (PRD). The question is: How’s the actual situation for the Pharma industry nowadays, specifically in the distribution channel?
When it comes to this channel, there are specific problems to resolve in time, mainly about aggregation. This is because the management of individual packs and their unique serial numbers needs a complete rework which could take a serious strain on a company’s inventory management in serialization.
In terms of traceability, it’s also extremely important to work with wholesalers that have integral systems with specific module for each one of their needs, including picking, validation and reception, as those are key parts of the chain.
Concerning these points, European distributors depend mainly on both specific aspects: who they get the products from and where they are sent. When received from the MAH, designated CMO or another official Wholesaler, the verification of serial numbers is unneeded. But if they receive them from any other source -such as an unofficial wholesaler- they would need to verify the serial number with a valid organization.
In case the products are being sent outside the European Union, like hospitals, jails, universities the serial numbers may need to be deactivated. In these situations, the deactivation will depend almost exclusively on the side of each countries’ internal regulation (from countries in the EU).
If your company is still not ready or has issues concerning the distribution channel or many of the others involved in the road to EMVO compliance, the best path would be to seek to outsource these operations with an already qualified partner that can resolve these problems on time and assure a timely solution, avoiding future problems in your supply chain for the upcoming quarters.
By Ariel Romero, Head of Sales EMEA at Verifarma