All Recipharm facilities ready for EU serialisation, regardless of Brexit

15 Feb 2019

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.

All Recipharm facilities ready for EU serialisation, regardless of Brexit

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."

Read More

Related news

India says shipments of hydroxychloroquine will resume after US exerts pressure

India says shipments of hydroxychloroquine will resume after US exerts pressure

7 Apr 2020

Our content has now moved to our new Global Pharma Insights website, providing the very latest news and information covering all aspects of the pharmaceutical supply chain. Please click the link below to access this article.

Read more 
Chinese CDMOs legislating for the future

Chinese CDMOs legislating for the future

2 Apr 2020

Our content has now moved to our new Global Pharma Insights website, providing the very latest news and information covering all aspects of the pharmaceutical supply chain. Please click the link below to access this article.

Read more 
FDA orders ranitidine withdrawal due to nitrosamine contamination risk

FDA orders ranitidine withdrawal due to nitrosamine contamination risk

2 Apr 2020

Our content has now moved to our new Global Pharma Insights website, providing the very latest news and information covering all aspects of the pharmaceutical supply chain. Please click the link below to access this article.

Read more 
China focused on meeting international API demand amid pandemic, say officials

China focused on meeting international API demand amid pandemic, say officials

1 Apr 2020

Our content has now moved to our new Global Pharma Insights website, providing the very latest news and information covering all aspects of the pharmaceutical supply chain. Please click the link below to access this article.

Read more 
CDMO Suven’s finished drug exports halted due to Indian COVID-19 lockdown

CDMO Suven’s finished drug exports halted due to Indian COVID-19 lockdown

25 Mar 2020

Indian contract development and manufacturing organisation, Suven Pharmaceuticals, has warned it cannot export finished products due to a shortage of raw materials following the country’s recent lockdown to fight the COVID-19 pandemic.

Read more 
2020 - a year for 'big answers' rather than 'big data'

2020 - a year for 'big answers' rather than 'big data'

7 Feb 2020

Zenith Technologies CEO, Joe Haugh, takes us through how the business has evolved this year, to better meet the needs of its customers, as well as the trends they see shaping the industry through 2020 and beyond.

Read more 
Inovio and Beijing Advaccine to advance vaccine against Coronavirus

Inovio and Beijing Advaccine to advance vaccine against Coronavirus

30 Jan 2020

Agreement will facilitate clinical trial translations in China.

Read more 
AstraZeneca embarks on $1bn zero carbon strategy

AstraZeneca embarks on $1bn zero carbon strategy

24 Jan 2020

The programme will include the launch of next-generation respiratory inhalers, which will use near-zero Global Warming Potential propellants.

Read more 
Diabetes diagnosis - now a matter of sweat and tears?

Diabetes diagnosis - now a matter of sweat and tears?

21 Jan 2020

No need to draw blood; researchers develop smart technology to diagnose diabetes and treat diabetic retinopathy.

Read more 
2019, the year that got serialization done!

2019, the year that got serialization done!

17 Dec 2019

The past 12 months have been busy as many companies fought to comply with serialization regulations.

Read more