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Smarter serialisation

02 November 2018

Ian Haynes, director at pharma consultant Excellis Europe, says enabling collaboration between parallel importers is helping simplify the transition to serialisation post EU-FMD.

The EU Falsified Medicines Directive (EU-FMD) requires serialisation of every pack, and parallel importers (PIs) face unique challenges. A parallel import is a non-counterfeit product imported from another country without the permission of the intellectual property owner.

The compliance deadline is 9 February 2019.

Under the banner of ‘manufacturers’ we not only find the originator manufacturers, but also PIs who repackage pharmaceuticals. These are small, but important companies that often play multiple roles within the supply chain. Specific assistance is required to enable these often complex companies to continue to operate after EU-FMD. 

Their obligations are more complex than that of the mainstream originators. PI companies are often relatively small with limited resources. They typically procure product from regulated EU wholesalers, so they must first carry out the risk-based verification of the product against the European Medicines Verification System (EMVS). During the process of repacking they have to decommission the originator product for repack and update the so-called ‘repack buffer’ in the EMVS; this repack buffer is then consumed as the PI company uploads their new product pack data for their repacked product. During the process of repackaging, the product is given a new Global Trade Item Number (GTIN), new batch number and a new unique identifier.  

PIs play an important role in the pharmaceutical supply chain, and the Government have confirmed that this role will be protected next year, with or without a Brexit deal.

The British Association of European Pharmaceutical Distributors (BAEPD) is the UK trade body for PIs, and engaged with Excellis Europe to work together on a serialisation project. 

From the outset, we adopted a fully collaborative approach to the project.

The factors that needed to be considered included: 

  • PI companies have a complicated incoming goods process unlike originators manufacturers.
  • PI companies need to handle two sets of serial number, original and new.
  • PIs manufacturing process is completely different to manufacturers.
  • PI companies are typically small with limited resources. 

Excellis Europe put together a User Requirements Specification (URS) and using our knowledge of the industry, generated a list of likely vendors. The URS went to the vendors and we ran a formal vendor selection exercise. We had to find the right vendor to match the specific culture of the PIs. After a rigorous assessment process, we found a vendor that had the components of a solution that would work, but equally importantly had the right cultural fit and excellent knowledge of the EU-FMD requirements and EMVS. 

Following a period of extensive development and piloting, the PI consortium are now rolling out the serialisation solution. This solution is now being implemented across the BAEPD consortium, and across the wider membership which has grown during the time of the project as more PIs seek to gain access to this solution.

Goods batching process has been a risk for PIs - the current manual processes have worked effectively but do present a possible risk of mixing up batches of incoming product. This new serialisation solution is utilised to remove the possibility of any such mix up. 

Another benefit to PIs is that the companies are choosing to aggregate incoming product into their internal inventory - they have uniquely identified containers and they know which serial numbers are in which containers. This means that they can find specific serialised packs much more quickly (they know which container they are in), and it also means that they can assign the serial numbers of re-pack orders for example by container, they don’t have to scan the product into each re-pack order.