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GBA Group Pharma, corporate

GBA Group Pharma,

28.07.2020 - 09:03:08

GBA Group Pharma updates on clinical trial risks following Brexit

The note also points out that as of 1 July, 2020, there were 250 trials registered in the European Clinical Trials database (EudraCT) where the QP is established in the UK and which have been authorised in at least one Member State other than the UK within the last 3 years.[2]

"With the UK now regarded as a "third country" from January 2021, it is vital that companies using UK-based QPs and other CTSM intermediaries must now act quickly. Companies need to establish QPs, by year-end, that know the relevant local language and regulations in the European Union. This may lead to a shortfall of QPs in the EU," said Elisabeth Lackner, CEO of GBA Group Pharma and ABF Pharmaceutical Services and continues: "Clinical trials cannot simply be stopped mid-trial. Any disruption can cause imperative reorganizations to existing qualified and audited supply chains for ongoing and planned clinical studies. Should a company need to switch QPs mid-trial, it might well be necessary for a new QP to requalify the entire supply chain. In addition to the massive impact of the corona crisis, there is another critical challenge facing the pharmaceutical industry."

A further issue facing non-EU companies is the movement of drug products within the Union. Today, these products can be transported and distributed without import or export duties. "With the completion of Brexit, UK manufactured drug products could be subject to a value-added-tax (VAT) if shipped into the EU," Lackner added.

GBA Pharma Group has defined a one-stop solution for pharma and biotech companies looking to do business in Europe that require support in import and release activities to help solve any inconsistencies related to the UK leaving Europe and the implementation of all the EMA regulations and restrictions.

"At GBA Pharma Group, we are well set for any regulatory changes. With all our GMP sites for CTSM, QP release, import, depot, labeling/packaging, commercials and global distribution, plus our GMP testing labs for batch release testing and import testing and our Central Lab all being located in the EU 27 - we are well prepared to offer Brexit-proof services to healthcare companies", Lackner noted.

CTSM services are coordinated through GBA Group Pharma's ABF Pharmaceutical Services, which works closely with other members of the GBA Group Pharma, such as: Germany-based Pharmacelsus for preclinical CRO work; LKF Laboratory for Clinical Trials; and GBA Pharma Labs, plus a partner depot in the UK.

About GBA Group Pharma GBA Group Pharma, headquartered in Hamburg/Germany, is one of the largest and most experienced service providers in the European pharmaceutical and biotechnology sector. As a unique "one stop solution", the company supports the comprehensive process of drug development and marketing, from preclinical to clinical services, including analysis services, provision of clinical trial goods, central laboratory services, QP services and support for release processes and the import & export of approved products.

GBA Group Pharma can meet all BREXIT-related service requirements of pharmaceutical and biotech companies with business activities in the EU. GBA Group Pharma employs around 500 people in Austria, Germany and the UK and is part of GBA Group, Hamburg.

For further information, please visit www.gba-group.com/pharma and follow us on LinkedIn and Twitter.

Media enquiries GBA Group Pharma Natalie Eiffe-Kuhn Mobile: +43 676 897115513 Email: Natalie.Eiffe@abf-pharma.comMC Services AG Julia Hofmann Phone: +49 89 210 228 0 Email: gba-abf@mc-services.eu[1]Technical notice to sponsors regarding continuous compliance with the EU legislation for clinical trials1 following the withdrawal of the united kingdom from the EU[2] As of 1 July, 2020, based on data registered in the European Clinical Trials database (EudraCT)

28.07.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de

1102731  28.07.2020 

@ dgap.de