Contents

SUBCHAPTER 340 - INTERNATIONAL AGREEMENTS

340 - 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 following is a listing of these agreements. The complete text of the agreements is in the International Cooperative Agreements Manual. The listing is by country and CPG order. Please also refer to FDA's website at http://www.fda.gov/oia/default.htm for additional information.

340.01 - Australia

MOU with:

1. Australia Regarding Dry Milk Products (7156f.01)
2. The Export Inspection Service, Dept. of Primary Industry, Australia Concerning Fresh Frozen Molluscan Shellfish.

340.02 - Belgium

MOU with the Ministry of Agriculture of Belgium Represented by the National Dairy Office Concerning the Sanitary Quality of Dry Milk Products.

340.03 - Canada

MOU with:

1. Canada Regarding Radiation Emission and Human Exposure from Electronic Products.
2. Canada Covering the U.S. Interstate Travel Sanitation Program and the Canadian Common Carriers Program.
3. Canada Regarding Good Laboratory Practices.

Agreement with:

1. Canada Concerning Exchange of Drug Plant Inspection Information.
2. Canada on Sanitary Control of Shellfish Industry.

340.04 - Republic of Chile

MOU with:

1. The Ministry of Economic Development and Reconstruction, Subsecretariate of Fisheries, Republic of Chile Regarding the Safety and Wholesomeness of Fresh and Frozen Oysters, Clams, and Mussels Exported to the United States.

2. The Agricultural and Livestock Service, Ministry of Agriculture of the Republic of Chile Regarding Cooperation in Establishing and Implementing Emergency Procedures to Ensure the Safety of Fresh Fruit Exported to the United States.

340.05 - People's Republic of China (PRC)

MOU with the State Administration of Import and Export Commodity Inspection of the PRC Covering Ceramic ware Intended for Use in Preparation, Serving, or Storage of Food or Drink and Offered for Export to the United States of America.

340.06 - Denmark

MOU with the State Quality Control for Dairy Products and Eggs, Etc., Denmark, Concerning Dry Milk Products Exported to The US.

340.07 - Finland

MOU with Finland to Establish Certification Requirements for Various Foods to Minimize FDA Audit Sampling of those Foods Exported to the US.

340.08 - France

MOU with:

1. French Ministry of Social Affairs and National Solidarity Office of Pharmaceuticals & Medicines to Exchange Information Regarding Non-clinical Laboratories.
2. The Ministry of Agriculture, Republic of France Regarding Caseins, Caseinates, and Mixtures Thereof Exported to the US.

340.09 - Federal Republic of Germany (FRG)

MOU with the Environmental Protection Agency and the Federal Minister of Food, Agriculture, and Forestry, the Federal Minister for Youth, Family Affairs, Women and Health, and the Federal Minister of the Environment, Nature Conservation and Nuclear Safety of the FRG Regarding Good Laboratory Practice.

340.10 - Iceland

MOU with The Ministry of Fisheries, Government of Iceland Concerning Fresh and Fresh Frozen Oysters, Clams, and Mussels.

340.11 - Ireland

MOU with Ireland Covering Caseins, Caseinates, and Mixtures Thereof Exported to the United States.

340.12 - Italy

MOU with the Pharmaceutical Service, Ministry of Health, Republic of Italy Regarding Good Laboratory Practice.

340.13 - Japan

Agreement with Japan on Shellfish Sanitation.

340.14 - Republic of Korea (ROK)

MOU with:

1. ROK Regarding Exchange of Toxicological Information Between National Center for Toxicological Research and the Korea Research Institute of Chemical Technology.
2. ROK Regarding Frozen Molluscan Shellfish for United States Consumption.

Agreement with:

1. ROK Concerning Cooperation Regarding Fishery Resources.

340.15 - United Mexican States (UMS)

MOU with:

1. The Secretaria De Salud, UMS Regarding Cooperation in the Scientific and Regulatory Areas of Foods, Drugs, Cosmetics, Biologics (Including Blood and Blood Products), and Medical Devices.
2. The Secretariat of Health of the UMS Regarding Fresh and Frozen Oysters, Clams, and Mussels.
3. The Secretariat of Agriculture and Water Resources, UMS Regarding Mutual Cooperation in the Regulation of Raw Agricultural products Involved in Commerce Between Mexico and the United States.

340.16 - Netherlands

MOU with:

1. The Directorate General for Agriculture and Food of the Ministry of Agriculture and Fisheries of the Netherlands Concerning Dry Milk Products Exported to the US.
2. The Ministry of Welfare, Health and Cultural Affairs, The Netherlands, on Good Laboratory Practice.

340.17 - New Zealand

MOU with:

1. Ministry of Agriculture and Fisheries, New Zealand Relative to Exporting Dry Milk Products to the US.
2. New Zealand Regarding Exportation of Fresh and Fresh Frozen Shellfish to the U.S.

340.18 - Northern Ireland

MOU with the Department of Health and Social Security of the UK and Northern Ireland Regarding the Recognition of Inspections of Manufacturers of Medical Devices.

340.19 - Norway

MOU with Norway Regarding Rennet Casein Exported to the U.S.

340.20 - Philippines

MOU with the Republic of Philippines Concerning Various Food Products Exported from the Philippines to the United States of America.

340.21 - Sweden

MOU with:

1. The Swedish National Board of Health & Welfare Concerning Exchange of Inspectional Information.
2. The Swedish National Board of Health and Welfare and the FDA Concerning Good Laboratory Practices.
3. The Swedish Government Control Board of Dairy Products & Eggs Concerning Exporting Dry Milk Products to the US.

340.22 - Switzerland

1. MOU with Switzerland Regarding Good Laboratory Practice Inspections and the Reciprocal Recognition of Each Countries GLP Program.
2. Agreement with Switzerland Regarding United States Acceptance of Swiss Drug Inspections.

340.23 - United Kingdom (UK)

MOU with:

1. The United Kingdom Regarding Fresh and Fresh Frozen Shellfish.
2. The Department or Health and Social Security of the UK and Northern Ireland Regarding the Recognition of Inspections of Manufacturers of Medical Devices.
3. The Office of Pesticides and Toxic Substances, U.S.EPA, and the Medical Division of Toxicology and Environmental Protection, United Kingdom Department of Health and Social Security Regarding Good Laboratory Practice.

341 - MUTUAL RECOGNITION AGREEMENTS

341.01 - 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 803. Additional specific information is available at http: //www.fda.gov/oia/homepage.htm.

341.02 - Pharmaceuticals and Medical Devices

The first mutual recognition agreement (MRA) to be implemented, The Joint Declaration to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA) was signed in May 1998. It consists of the following sections:

• Framework
• Telecommunication Equipment
• Electromagnetic Compatibility (EMC)
• Electrical Safety
• Recreational Craft
• Pharmaceutical Good Manufacturing Practices (GMPs)
• Medical Devices

It covers both FDA regulated and non-FDA regulated products and is an agreement between the United States and the European Union (EU) representing 15 Member States. It establishes procedures leading to FDA acceptance of inspectional work done by (EU) Regulatory or Competent Authorities (RA/CA) or Notified Bodies termed Conformity Assessment Bodies (CABs) in the MRA. The pharmaceutical annex is based on an assessment of equivalence with the Member States and the medical device annex is based on inspections by non-government firms who are recognized by the Member State regulatory authority. FDA has begun the process of implementing this agreement which has a 3 year transition period before the operational phase.

341.03 - 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.