The serialisation of licensed drug products will be a legal requirement for companies in the EU from early 2019
Swedish contract development and manufacturing organisation (CDMO) Recipharm plans to invest â‚¬40m over the next three years to ensure state-of-the-art solutions for serialisation processes.
The move by the company comes as the announcement of the EU Falsified Medicines Directive (EUFMD) Safety Features Delegated Regulation is released. This means that the serialisation of licensed drug products will be a legal requirement for companies in the EU from early 2019.
Recipharm already provides serialised products in markets including Turkey, Korea and China. A newly established, dedicated global steering committee will now also work closely with clients in Europe to ensure they plan and implement changes that comply with pending regulatory requirements for drug serialisation.
The company-wide serialisation project is being led by Staffan Widengren, Director Corporate Projects at Recipharm. He said: 'Having worked with many clients in Asia on track and traceability, we know the complications and challenges of serialising a product from start to finish. The process can be complex and time consuming, particularly if the right tools and expertise are not in place, so we need to move this issue up the agenda for firms in Europe.'
we are aiming to be as proactive as possible with the introduction of serialisation
He added: 'We know that several pharmaceutical companies are behind in their preparations, mainly because the changes seem so far away. In reality, these organisations must look ahead and face this issue head on as changes take a long time to implement in a complex supply chain.
'As a company, we are aiming to be as proactive as possible with the introduction of serialisation in order to support and advise our clients, create a clear strategy and prepare them for inevitable changes. If companies are underprepared, the new requirements have the potential to significantly impact their product supply. As a result, we expect to see increased demand for specialist outsourced services as the deadline looms ever closer.'
The industry-wide serialisation, aggregation and verification directive is expected to improve traceability of drugs, help in theÂ fight against counterfeit products entering the supply chain and ultimately improve patient safety.
However, the implementation of required changes to the 2D barcodes on all saleable drug items will require significant investment from the pharmaceutical industry.
Recipharm serves 250+ customers and expects 85% of its production to require serialisation. The firm will also be ready for US serialisation from November 2017 in-line with the US Drug Supply Chain Security Act (DSCSA).
Kjell Johansson, President Manufacturing Services Europe, said: 'The task force we have established at Recipharm will drive this project across all of our sites to ensure we support clients in terms of education and readiness for the changes ahead. Ultimately, our aim is to use our expertise to guide clients through this process and add as much value as possible. At the same time, we will work with our customers to minimise the cost implications.
'Over the next few months, we will be consulting with our customers about payment models and the most efficient way to incorporate the cost ofÂ serialisation into their projects in both the short and long term.'
Recipharm is preparing a range of educational papers aimed at training staff internally across its global network and supporting customers with the challenges of serialisation, verification and complying with new regulatory requirements.