Moravia Provides Guidance to Life Sciences Sector as Croatia Nears EU Accession and European Medicines Agency Deadlines Loom
Accession highlights international business opportunity and complexity as industry faces new regulatory standards in Croatia
Brno, Czech Republic – April 10, 2013
As Croatia prepares to join the European Union (EU) on July 1, global and regional life sciences companies are facing regulatory and compliance deadlines in accordance with EU European Medicines Agency (EMA) standards.
Companies must accurately localize and translate all product labels and documentation into Croatian before July 1, otherwise they cannot market those products in the EU.
The EMA legally requires that pharmaceutical companies using the EMA’s centralized marketing authorization procedure make their product information available in any new EU member’s official language as of the member’s date of accession. This means companies must accurately localize and translate all product labels and documentation into Croatian before July 1, otherwise they cannot market those products in the EU.
Moravia, a leading globalization company that helped pioneer localization in Croatia, says time is running out before the EMA’s pending April 30 deadline for companies to submit translated documents and labels for verification. Any information sent past that deadline might not be certified by the EMA before Croatia’s accession date, causing delay and missed marketing opportunities.
“Due to the size of the language, there is a limited pool of Croatian translators that can provide accurate product information translations. Therefore, it’s important that companies choose a quality partner to help them smoothly navigate the EMA process,” said Renato Beninatto, Chief Marketing Officer at Moravia. “Time is of the essence for companies trying to meet the Croatia accession deadlines. But new translation technologies available through providers like Moravia can help ensure fast project turnaround and delay-free regulatory approval.”
A translation leader in the life sciences industry, Moravia holds ISO 13485 and EN 15038 certifications that illustrate the company’s commitment to the industry’s global standards.
Moravia is a leading globalization solution provider, enabling companies in the information technology, e-learning, and life sciences industries to enter global markets with high quality multilingual products. Moravia's solutions include localization, product testing, internationalization, multilingual publishing, technical translation, content creation, machine translation, and workflow consulting. Our dedicated testing and engineering solutions help companies succeed with their software and hardware products globally through services including test development, linguistic and functional testing, test automation and software engineering. Moravia Worldwide maintains global headquarters in the Czech Republic and North American headquarters in California, with local offices and production centers in Japan, China, Latin America, Ireland, USA and throughout Europe. To learn more, please visit www.moravia.com.
Europe & APAC
Libor Safar, Marketing Manager
libors (at) moravia.com
Renato Beninatto, Chief Marketing Officer
renatob (at) moravia.com
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