Navigation Links
Moravia Provides Guidance to Life Sciences Sector as Croatia Nears EU Accession and European Medicines Agency Deadlines Loom
Date:4/10/2013

NEWBURY PARK, Calif., April 10, 2013 /PRNewswire/ -- 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.

(Logo: http://photos.prnewswire.com/prnh/20121012/DA92092LOGO)

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.

About Moravia

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. The company 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. www.moravia.com.

 


'/>"/>
SOURCE Moravia
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. MediPendantâ„¢ to Return to Television on May 20th New Television Campaign - Company Provides MediPendantâ„¢ Update
2. Anthera Pharmaceuticals Reports 2012 First Quarter Financial Results And Provides Clinical Progress Update
3. Regeneron Provides Update On FDA Advisory Committee Discussion of ARCALYST® (rilonacept) Injection
4. Simcere Pharmaceutical Group Provides Notice of Annual General Meeting
5. Elevate Provides Remote Access to Personal Health Records Using MyMedicalRecords.com
6. Health Diagnostic Laboratory, Inc. Provides Grant to Support National Lipid Association, Sponsors 2012 Annual Scientific Sessions in Scottsdale, Arizona
7. NexGen Biomedical, Inc. Provides New Insights Into Jett Travoltas Seizure Related Death
8. Concord Medical Announces its Successful Closing of the Acquisition of 52% Ownership in Changan Hospital and Provides Guidance for Financial Results of the Second Quarter of 2012
9. TPI Provides Further Updates on its GMOL Flagship Product
10. BSGI Molecular Breast Imaging Provides Better Results than MRI for Cancer Patients with Dense Breasts
11. Publication of PrEP Trial Data Provides Clear Evidence that PrEP Works for Men and Women
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 2016   Bay Area Lyme Foundation , ... Center for Tick Borne Illness , Harvard Medical ... Hacking Medicine, University of California, Berkeley, and the ... five finalists of Lyme Innovation , the ... 100 scientists, clinicians, researchers, entrepreneurs, and investors from ...
(Date:6/24/2016)... 2016 The Academy of Managed Care Pharmacy ... that would allow biopharmaceutical companies to more easily share ... formulary and coverage decisions, a move that addresses the ... The recommendations address restrictions in the sharing ... drug label, a prohibition that hinders decision makers from ...
(Date:6/24/2016)... , June 24, 2016 Research and ... Market for Companion Diagnostic Tests" report to their offering. ... for Companion Diagnostics The World Market for ... personalized medicine diagnostics. Market analysis in the report includes the ... Market (In Vitro Diagnostic Kits) by Region (N. America, EU, ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. ... his M.D from the David Geffen School of Medicine at UCLA. He trained in ... to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he ...
(Date:6/25/2016)... ... 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the ... to iHire in recognition of their exemplary accomplishments in worksite health promotion. , The ... Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one ...
(Date:6/24/2016)... , ... June 24, 2016 , ... A recent ... most people are unfamiliar with. The article goes on to state that individuals are ... many of these less common operations such as calf and cheek reduction. The Los ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle Cell ... pain and the benefits of holistic treatments, Serenity Recovery Center of Marne, ... Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red blood ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Sessions in Dallas that it will receive two significant new grants to support ... as PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists ...
Breaking Medicine News(10 mins):