As we talked about the importance of serialization in our previous article Serialization – One step towards counterfeit-free future, one step against fear abuse, let’s now focus on what pharmaceutical Parallel Importers are facing under the EU FMD.
More than one year after the EU FMD came into force up to 80% of the companies in Europe have been adopted serialization solutions and the process has proven itself as very successful.
Since the implementation of Track & Trace systems, already a few companies have been caught with counterfeit drugs.
Statistics show that more than 250 000 people globally die due to counterfeit drugs.
In a nutshell, the serialization has been introduced to the world as an instrument for control and monitoring of the highly complex processes of the supply chain, starting from the manufacturer all the way to the end consumer. The authentication of the pharmaceutical products at various levels within the supply chain is a key factor for transparent processes in the life cycle of the pharmaceutical goods.
With pharmaceutical sales ranging from €150 billion to €200 billion per year, according to industry estimates, and the counterfeit pharmaceuticals are the most lucrative sector of the global trade in illegally copied goods. In this context, the serialization ensures protection against counterfeiting and limits products from slipping into the grey market.
In the last few years, the tendency is that the Parallel Traders take a very important role in the EU pharmaceutical sales.
According to the latest IQVIA statistics parallel import sales have increased by 3% in 2019 compared to 2018. Currently, parallel import sales are measured at 5.7bn euros.
Furthermore, with today’s Covid-19 situation we have faced, the Parallel Traders play a key role in the pharmaceutical industry by eliminating medicine shortages in different markets.
But what are the challenges which the Parallel Traders are facing?
Parallel Distributors/Importers face multiple challenges due to complex verification process and strict reporting requirements. Without implementing proper tools to help them through this complex process Parallel Distributors/Importers can be exposed to the issues with Source Product Verification as:
- Invalid capture of the incoming initial/source barcodes before starting their production process.
- Incorrect advanced verification process impose payment without actual production
The packaging redesign is one of the issues considered as challenging. Much of the packaging and artwork for medicine packs have had to undergo a re-design. During the carton redesign process, a thing to be kept in mind is that the cartons should have unvarnished areas to accommodate all the necessary serialization data.
The repacking process is difficult to monitor and very time and effort consuming. It can be troubled to be an inaccurate relabelling and repackaging which imposes authority audits and alerts from the National System of the target market.
Another issue-related condition can be the poor-quality prints and erroneous verifications of target cartons which can lead to unexpected costs due to bad print, damaged/decommissioned products, barcode reader functionalities.
All these challenges together with all requirements and responsibilities for Pharma Parallel Importers as well as how the main process is happening after the Falsified Medicines Directive in Europe are topics of our webinar “Keep the pace of Parallel Trade Track and Trace”.
Ask for the recording of our hands-on experience sharing and become well-prepared for a smooth Parallel Trade in Europe.