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Friday, May 22, 2015

Industry Focus

Language requirements for EU medical device labels

Libor Safar, Helen Colquhoun & Cheryl Hill

These specify a more direct requirement for translations of pharmaceutical labeling and package leaflets — the specific information must be provided in the official languages of a given member state (rather than “may be required"). In addition, the EU established the European Medicines Agency (EMA), which administers the centralized procedure for marketing authorization. This allows direct access to all EU and European Economic Area (EEA) and European Free Trade Association (EFTA) countries via a single application, whereby the product information such as summary of product characteristics, labeling and package leaflets needs to be submitted in all EU languages plus Icelandic and Norwegian. 

The agency is also a hub of the European medicines network, which comprises over 40 national competent authorities in the 30 EU and EEA-EFTA countries, and plays a role in the other decentralized or mutual recognition procedures, which allow for a marketing authorization in a selected number of countries. . .

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Above excerpt taken from the September 2012 issue of MultiLingual published by MultiLingual Computing, Inc., 319 North First Avenue, Suite 2, Sandpoint, Idaho 83864-1495 USA, 208-263-8178, Fax: 208-263-6310. Subscribe

September, 2012