Monday, January 7, 2019

EU FMD: Leveraging the ‘EMVO Gateway’ option for manual serialization data entry/file upload to the EMVS.

With just over a month until the EU FMD deadline pharma manufacturers should be putting the final touches on their compliance solutions- most integral of which is how they will communicate serialization and related data to the European Medicine Verifications System.

For manufacturers of any significant size/scale this communication of data is being handled by 3rd party vendors who directly integrate with the EMVS.   This enables a largely ‘hands off’ approach for the manufacturers- as their product gets serialized at packaging sites/CMOs the data flows to their 3rd party vendor system who, in turn, re-formats and communicates to the EMVS (at least this is how it should work :))

Another, fairly under-publicized, option exists however- known as the EMVO Gateway.    The Gateway is a web user interface which manufacturers can access and perform all the necessary data communications to the hub.   The Gateway generally provides two options for uploading data- manual entry (via typing or scanning of a barcode into the web user interface) or file upload (uploading a pre-populated file)

The EMVO Gateway is an intriguing option for the following use cases:

  1. For companies whose 3rd party vendor is having issues and/or not on track to meet the upcoming deadline.
  2. Companies who wish to maintain a secondary (back-up/fallback) solution to reduce overall compliance risk or dependency on a 3rd party vendor.
  3. For companies who serialize product infrequently and/or at low volumes such that a more manual option is feasible.

A few key insights about the EMVO Gateway:
  1. The Gateway connection can be maintained in parallel to a 3rd party vendor connection.  Credit to the EMVO for recognizing that most manufacturers would see the value in having two connections enabled at the same time.  This means there is little to no risk (and cost) for a manufacturer to enable the EMVO Gateway as a backup option.
  2. The file formats which can be uploaded via the Gateway are NOT the same as files sent directly to the EMVS interfaces.  Don’t assume you can simply take files from your 3rd party vendor and upload them via the Gateway in case your 3rd party vendor fails.
  3. EMVO Gateway supports all necessary functions (master data upload, pack upload, pack update, batch update, recall, report requests).
Whatever the use case may be there are some key hurdles which must be cleared in order to properly register and initially set up the EMVO Gateway access- and even more importantly these tasks can be time-consuming.  To ensure your EMVO Gateway access is available come Feb.9 it is strongly advised that you begin the process ASAP.

If you need help getting access to your EMVO Gateway or have questions as to how the EMVO Gateway option may be best positioned in addition to, or in place of, a 3rd party vendor connection reach out to Be4ward for expertise.  Jennason is proud to have developed a solution in collaboration with Be4ward (Link) which ensures companies can use the EMVO Gateway option effectively and efficiently.

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