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How Clinical Trials Supplies Labelling May Be Affected by the Extended EU Local Language Requirements and How Integrated Labelling Systems Could Provide a Solution

This article is intended to keep readers informed about the developments concerning the local language requirements for EU member states when producing clinical trials supplies labels. The first part of the article deals with the reasons why the EU's local language requirement is about to become more difficult to meet, and the second part offers some potential solutions.

EU Expansion

Many labelling requirements are listed within the current regulatory framework and are transposed across all member states in Europe. Member states require labelling in their national language when the clinical trials supply product reaches the patient. Member states may authorise information to be in one or more community languages. The local language requirements are not new in themselves; it's just the ever-increasing number of languages required on the label and our customers' experiences of increased inspection activities in this area.

It is now almost certain that Eastern European countries will enact similar legislation regarding the need for local language labelling due to the planned expansion of the EU scheduled for 1 st May 2004 - under one year from now. The existing list of 15 members will be expanded to include 10 more from May 2004. The new countries are: Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovak Republic and Slovenia. These countries are currently known as the 'acceding countries' and are all on schedule to meet the joining requirements. It is also expected that Bulgaria and Romania will join the EU in 2007. Part of the requirement for expanded membership is for each country to adopt the common rules, standards and policies that make up the body of the EU law. Once again, it is almost certain that the new EU countries will adopt the local language requirements. This will result in clinical trials supplies labels needing to handle the wider language requirements, which some systems struggle to cope with at the moment.


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By Bob Tilling, Director of New Business Development at MAP80 Systems Limited

Bob Tilling is the Director of New Business Development for MAP80 Systems Limited, a UK-based developer of labelling software for the pharmaceutical and medical industries. Bob has over eight years' experience with major labelling projects for well-known pharmaceutical, medical and clinical trials companies. His advice has assisted many companies in solving such labelling problems as the local language requirement for products distributed worldwide and the use of labelling software within a GMP environment. Recently, Bob has been providing advice to companies considering the implementation of a single worldwide labelling system and has presented papers on this subject at several industry seminars.

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