All Recipharm facilities ready for EU serialisation, regardless of Brexit
The CDMO invested EUR 35 million into its operations and launched a 3-year programme to provide a compliant serialisation solution for its customers.
Recipharm has announced that all 15 of its facilities outlined in its investment plan are now fully prepared for drug serialisation and have delivered serialised batches within Europe ahead of the 9 February deadline.
During the period 2016-2018, the CDMO invested EUR 35 million into its operations and launched a 3-year programme to provide a compliant serialisation solution for its customers, ahead of the introduction of the EU Falsified Medicines Directive (EU FMD) and the US Drug Supply Chain Security Act (DSCSA).
In addition, all of the facilities are connected to customers to allow them to report serial numbers. The facilities are located across Europe in France, Italy, Sweden, Spain, Germany, the UK and Portugal, as well as in India.
Staffan Widengren, Director Corporate Projects, said: “Recipharm has been very committed to meeting compliance deadlines, establishing a dedicated task force 3 years ago. A lot of time and effort has gone into our preparations so it’s rewarding to report that we are ready, especially ahead of the enforcement date.”
“Standardising our serialisation capabilities has enabled us to provide a seamless and flexible service to our customers, across multiple markets.”
After months of operational upheaval, the EU FMD regulation is now in effect. As CDMOs try to adhere to serialization requirements, how could Brexit affect the new regulations and how does Recipharm aims to handle products during this period?
"The uncertainty of Brexit lingers, pharmaceutical companies are still unsure as to how Brexit will affect the FMD requirements, said Staffan Widengren. He continued: "When the UK leaves the EU on Friday 29 March, it could be that the UK market does not require serialised products, whereas the EU will uphold the regulations. This means that when drug products are transferred from the UK to the EU market, they will still need to comply with FMD requirements.
"Ultimately, the operational approach of pharmaceutical firms will depend on whether the UK remains part of the current European Medicines Verification Organization (EMVO) or European Medicines Verification Systems (EMVS), like many of the European Election Studies (EES) countries, or if they decide to adopt a new and separate system.
"In the meantime, Recipharm will handle all products as EU products and report serial numbers to the EU Hub and national systems. It is imperative that pharma companies not yet compliant with the new regulation, outsource their serialisation requirements and co-operate with their partners as this will ultimately help to protect the safety of patients."
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance