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U.S. Department of Health and Human Services

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FDA-EC-EMEA -- Extension

EXTENSION OF CONFIDENTIALITY ARRANGEMENT
BETWEEN THE UNITED STATES FOOD AND DRUG ADMINISTRATION
AND THE EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY
DIRECTORATE-GENNRAL AND THE EUROPEAN MEDICINES AGENCY
TO EXCHANGE REGULATORY INFORMATION

Whereas the United States Food and Drug Administration (USFDA) and the European Commission’s Enterprise and Industry Directorate-General (DG Enterprise) and the European Medicines Agency (EMEA) (collectively, the Participants) exchanged letters on September 12, 2003 establishing a Confidentiality Arrangement to exchange regulatory information; and

Whereas it was agreed between the participants that the Confidentiality Arrangement was intended to be in effect for a period of two years, at the completion of which the Participants would assess the arrangement’s effectiveness; and

Whereas the Participants have assessed the effectiveness of the Confidentiality Arrangement and found that it is a useful tool in transatlantic regulatory cooperation;

The Confidentiality Arrangement, in annex to this extension, is hereby extended for a period of five years from the last date of signature of this document.

_____/s/_____
Lester M. Crawford, D.V.M., Ph.D.
Commissioner of Food and Drugs
United States Food and Drug Administration

Date: SEP -7 2005
_____/s/_____
Georgette Lalis
Director, Directorate F
Enterprise and Industry Directorate-General
European Commission

Date: Sept 12 2005
_____/s/_____
Thomas Lönngren
Executive Director
European Medicines Agency

Date: Sept 15 2005