Translation After 1 May 2004
Before their accession to the European Union (EU) in May 2004, the Central and Eastern European Countries (CEECs) - Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia - had been transposing a large number of EU directives for the medical device and pharmaceutical industries.
Organizations such as the Pan European Regulatory Forum (PERF) were established to provide to the countries' competent authorities and stakeholders a central forum to help establish and manage the seemingly overwhelming processes and complexities that accompany EU accession.
Manufacturers in the highly regulated life sciences industries, whether headquartered close by in neighboring countries or more remotely in the Americas or Asia, are compelled to manage fundamental shifts in their approach to the "new," expanded Europe.
In this article, this complexity is addressed by providing information about the individual countries and market conditions, as well as some suggestions (good practices) on how to manage the translation of content for regulatory requirements and market acceptance. Also discussed are models that manufacturers have set up to manage a quality localization process.
The BBC News Euro-glossary defines acquis communautaire as follows: "The entire body of European Laws is known as the acquis communautaire. This includes all treaties, regulations and directives passed by the European institutions as well as judgments laid down by the Court of Justice. They [candidate countries] must adopt, implement and enforce all the acquis to be allowed to join the EU."
So what has this meant to the once-candidate, now new-member states? A huge task. In the years leading up to 1 May 2004, the new member states have had to adapt, adopt and harmonize the regulatory requirements to be in compliance. They have then had to be prepared to enforce EU regulations such as Conformité Européenne (CE) Marking and directives like the Medical Device Directive and the In Vitro Device Directive. Certain countries were more prepared for this transition than others were. Some countries have taken local language requirements to a new level of intensity after years of seeming indifference or inability. The existing member states, having blazed this trail years earlier, have helped ease the sometimes-painful transition.
So what does this mean to the life sciences industry? Time and money.
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Copyright 2004, by the Regulatory Affairs Professionals Society (RAPS). Posted with permission on www.moravia.com. Reprinted from the August 2004 issue of Regulatory Affairs Focus. This article may not be published, reposted or redistributed without express permission from RAPS and payment of appropriate fees when applicable. To obtain such permission, send a message to reprints(at)raps.org.