Trilateral Cooperation Charter between the Secretariat of Health of the Mexican United States, through the Federal Commission for the Protection from Sanitary Risks; the Health Products and Food Branch of the Department of Health of Canada; and the Food and Drug Administration within the Department of Health and Human Services of the United States of America

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The Secretariat of Health of Mexico, through the Federal Commission for the Protection from Sanitary Risks of the Mexican United States; The Health Products and Food Branch of the Department of Health of Canada; and the Food and Drug Administration within the Department of Health and Human Services of the United States of America (hereinafter referred to as "the Participants"):

• Recognizing the mutual benefits of collaborating on product safety and advertising within North America;
• Considering the good work done under the Trilateral Cooperation Charter, signed on February 27, 2004 ("2004 Trilateral Cooperation Charter");
• Desiring to continue cooperation with additional participants (when more than one agency has jurisdiction over parts of a product class within a country); and
• Seeking to establish a broader basis to guide continued collaboration;

Have come to the following understanding:

1. The purpose of this Trilateral Cooperation Charter is to improve product safety from a product life-cycle approach, as well as to protect and promote public health within North America through a trilateral forum that facilitates the communication, collaboration, leveraging of resources, and the exchange of information on issues of mutual interest among the three countries.

2. In pursuit of the purposes of this Trilateral Cooperation Charter, the Participants intend to engage actively in achieving the following strategic objectives:

   1. Identifying and solving problems related to product safety and advertising;

   2. Sharing information and best practices, and establishing coordinated positions on issues of mutual interest related to product safety, such as recall, standards, and third-party certification;

   3. Enhancing trust among the Participants and public confidence related to product safety and advertising within North America.

3. To achieve these objectives, the following principles should guide the Participants:

   1. A focus on health and safety issues, by using a scientific, risk-based, life-cycle approach;

   2. The advancement of product-safety efforts within North America; and

   3. Equal participation of all Participants.

4. Collaboration under this Trilateral Cooperation Charter is intended to cover all products regulated by, and common to, the Participants so as to permit meaningful cooperation between them. This may include, but is not limited to the following: drugs, biologics, cosmetics, medical devices, dietary supplements/natural health products, and food.

5. This Trilateral Cooperation Charter should not deal with issues addressed in other fora; unless the Participants agree to do so as a means of solving a specific problem that is affecting the three countries.

6. Collaboration under the Trilateral Cooperation Charter is not a substitute for bilateral cooperation between two of the participant countries. Participants should continue to use existing fora, or to create new fora, to discuss bilateral issues, as appropriate.

7. This Trilateral Cooperation Charter is a non-binding arrangement, and nothing in it is intended to create obligations under international or other law. The Participants intend to conduct all activities pursuant to this Trilateral Cooperation Charter in accordance with their respective laws and regulations.

8. Each Participant intends to fund its own activities under this Trilateral Cooperation Charter, subject to the availability of personnel, resources, and appropriated funds, unless the Participants decide otherwise.

9. The Participants may invite other organizations or agencies to participate in the discussions of issues contemplated under this Trilateral Cooperation Charter

10. The Participants intend to establish and operate according to operational guidelines, which they will draft subsequent to the signature of the Trilateral Cooperation Charter.

11. Each Participant should identify and communicate to other Participants the name(s) of the individual(s) intended to represent their Agencies.

12. The Participants may, through mutual written consent and approval, amend this Trilateral Cooperation Charter.

13. This Trilateral Cooperation Charter replaces the "Trilateral Cooperation Charter between the Health Products and Food Branch of Health Canada, Canada, The Food and Drug Administration within the U.S. Department of Health and Human Services, and the Federal Commission for the Protection from Sanitary Risks of the Secretaria de Salud of Mexico", signed in 2004.

14. This Trilateral Cooperation Charter is in place indefinitely, unless any Participant decides to withdraw. A withdrawing Participant should provide 30 days' written notice to the other Participants.

Signed in three original copies, in the English, French, and Spanish languages.

For the Secretariat of Health of the Mexican United States
Dr. José Ángel Córdova Villalobos, Secretary of Health
Lic. Miguel Ángel Toscano Velasco, Federal Commissioner for the Protection from Sanitary Risks, responsible agency for the management, evaluation, execution, and conformity of this Charter.

For the Health Products and Food Branch,
Department of Health of Canada
Meena Ballantyne, Assistant Deputy Minister

For the Food and Drug Administration,
Department of Health and Human Services of the United States of America
Margaret A. Hamburg, M.D., Commissioner of Food and Drugs

Date: October 14, 2009