Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 3.4 - INTERNATIONAL AGREEMENTS

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 3.4.1 - MEMORANDA OF UNDERSTANDING

The Agency has over the years entered into agreements with foreign governments regarding the quality of foods, drugs, and other products exported to the United States. The complete text of the agreements is in the International Cooperative Agreements Manual. The listing is by country and CPG order. Refer to FDA's website at http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/default.htm for additional information.

 3.4.2 - MUTUAL RECOGNITION AGREEMENTS

 3.4.2.1 - European Community

Changes in FDAMA have required that FDA begin the process of acceptance of mutual recognition agreements relating to the regulation of FDA regulated commodities, facilitate commerce in devices between the US and foreign countries and other activities to reduce the burden of regulation and to harmonize regulatory requirements. See Section 410 of FDAMA. Additional specific information is available at http://www.fda.gov/oia/homepage.htm.

 3.4.2.2 - Food Products

In July, 1999, the United States and the EC signed the "AGREEMENT BETWEEN THE UNITES STATES OF AMERICA AND THE EUROPEAN COMMUNITY ON SANITARY MEASURES TO PROTECT PUBLIC AND ANIMAL HEALTH IN TRADE IN LIVE ANIMALS AND ANIMAL PRODUCTS". This agreement is very much like a mutual recognition agreement and is based on the equivalence process. It covers a very wide range of human food products, all of animal origin, such as milk and dairy products, seafood, honey, wild game, snails, frog legs and canned pet food. For purposes of this agreement, the EC is considered one "party" and not 15 Member States. Activities to begin assessing equivalence are underway.

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