The 3C Excellis and Excellis Health teams spent the day in Amsterdam with seven Parallel Importers doing business in Netherlands, Germany and Norway, helping them select a Serialization solution provider to comply with the EMVO | European Medicines Verification Organisation FMD requirements.
“This is a great example of how the industry is coming together to address a challenging regulatory requirement” explained our President, International, Karan Narang.
“This may sound like another marketing message designed to get you to spend money on consultancy services such as those provided by 3C Excellis Europe, a subsidiary of Excellis Health Solutions.” Karan said, “But let me explain: For those smaller supply chain partners – such as parallel importers – serialization is a daunting challenge. They have limited resources; limited budgets and the cost of implementation may ultimately cost them their business. By bringing together parallel distributors we have created an approach to implementing serialization that can be shared by the group. Its not only an innovative way to address the challenge of traceability but it enables the stakeholders to share innovation.“
Parallel Importers and distributors are an important part of the European pharmaceutical supply chain operating on the basis of the free trade agreements in the EU Common Market. Whilst their business model – that is based on the price differential of medicinal products between countries – is sometimes frowned upon by others in the industry, Parallel Distributors claim – and the authorities and courts agree – that the service they provide is vital to the pharmaceutical trade in Europe, introducing cost savings into the marketplace and also stepping in to safeguard patient supply in shortage situations.
Organisations representing Parallel Importers and Distributors are taking their responsibilities seriously and have been playing an active and constructive role by collaborating with the other stakeholders to prepare the industry for the EU-FMD through the establishment of EMVO and implementing the EMVS.
Parallel Distributors are subject to specific requirements under the EU-FMD that are, in fact, more challenging than those of ‘normal’ Marketing Authorisation Holders: PDs need to decommission the original packs and then commission the Unique Identifiers for the new packs they import. As many Parallel Distributors are relatively small companies, this presents a significant challenge for this industry sector and could force some out of business. If this happens, this will create problems within the pharma supply chain.
It is therefore important that all stakeholders in the industry understand the challenges of the sector. They must work together to share knowledge and implement traceability in order to be able to continue to trade after the EU-FMD deadlines.
At 3C Excellis and Excellis Health Solutions we take our responsibility to our sector seriously. It is why we encouraged Parallel Distributors to address their needs as a collective whole. Their place in the supply chain already poses a number of challenges and serialization adds an extra level of complexity into their business model. We are working to ensure the pharma industry not only survives but flourishes post EU-FMD and innovative thinking to implementation is one way we are doing this. As our President, International Karan Narang said “This is a great example of how the industry is coming together to address a challenging regulatory requirement”.
Well for two main reasons:
Parallel distributors had already started talking to each other and we saw this and encouraged it.
“Working together the companies have accepted also the need to invest in bringing somebody like Excellis into the mix who really understands the industry, serialisation, traceability and how to implement it.”
“For Excellis, it allows us to show how we care about the pharma industry and we want everyone in the supply chain to achieve compliance.”
Their conversations enabled us to introduce an optimized approach to get them compliant. The benefits of this approach included:
Members of the Excellis team include strategic pharmaceutical and supply chain executives as well as tactical project management and implementation specialists.
This enables us to ensure we keep an eye on the overall goal of global pharmaceutical traceability initiatives – patient safety – while ensuring processes and solutions are deployed in the most optimal manner.
That you need experts in the subject matter as well the entire industry to ultimately drive you to serialization successfully. We’re lucky enough at 3C Excellis and Excellis Health Solutions to have to have the expertise and the specialists who are working hard every day to effectively implement traceability for our customers daily.
We will bring together this innovation, big-picture thinking and attention to detail when we present at the unique ‘listen and learn’ event that is GTT Europe which takes place on the 22nd February in Paris.
Join us at this free event for the cost-saving answers you need to implement: http://globaltrackandtrace.org/content.aspx?page_id=2&club_id=397779