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U.S. Food and Drug Administration |
Whereas the United States Food and Drug Administration (USFDA), Department of Health and Human Services, and the Australian Pesticides and Veterinary Medicines Authority (APVMA), Australia, hereinafter “the Participants,” are responsible for the regulation of animal drugs in their respective countries;
Noting that the Participants have a strong record of cooperation in various international fora to advance the effective regulation of animal drugs and a history of ad hoc direct cooperation on technical regulatory matters;
Acknowledging that the Participants recognize that there is mutual advantage to increasing the scope of, and strengthening the framework for, such cooperation; and
Recognizing that APVMA (a statutory authority established under the Australian Agricultural and Veterinary Chemicals Code Act 1994 (the Code Act)) and the USFDA (under authority of the U.S. Federal Food, Drug, and Cosmetic Act 1938 and its amendments) have similar approaches to regulation of veterinary medicines (animal drugs) in the broad sense and at the practical level in relation to the type of data required by both organizations;
The Participants have reached the following Understanding.
This Memorandum of Understanding (MOU) is intended to establish an information-sharing arrangement between APVMA and USFDA. The Participants intend to strengthen the exchange of knowledge and expertise to enhance the efficiency and effectiveness of their respective roles. This MOU focuses on cooperation in relation to the operational aspects of animal drug regulation and is not intended to cover broader government regulatory policy or to cover areas not falling under the common jurisdictional purview of the Participants.
Information exchanged under this MOU may include non-public information exempt from public disclosure under the laws and regulations of the United States or Australia. Information that is not appropriate for public dissemination is only to be shared according to the procedures and policies of the Participants and as permitted by their respective laws. Neither USFDA nor APVMA are to share trade secret information without the consent of the owner. US FDA and APVMA may also obtain the consent of the owner or individual prior to sharing other types of information. With regard to any non-public information that may be provided to APVMA by the USFDA or to the USFDA by APVMA, such transmissions are to be made in accordance with the specific signed confidentiality commitments and other requirements of the Participants.
Any exchange of information or other activity under this MOU is to be performed in accordance with applicable laws and regulations.
Each Participant intends to cover its own costs and recognizes the other’s responsibility to fund and carry out its own activities subject to, and to the extent made possible by, the availability of appropriated funds, personnel, and other resources.
Cooperation under this MOU commences upon signature by both Participants and is effective for a period of five (5) years from that date. It may be extended for additional five-year periods by mutual written agreement of the Participants. The MOU should be evaluated at least once in every five-year period by the Participants.
The Participants may amend this document by mutual written consent. This non-binding document may be terminated upon notice. Termination of this MOU should not affect the completion of cooperative activities that may have been formalized prior to termination.
The Participants do not intend this MOU to create legally binding obligations between them under international or other law.
Any disagreement regarding the interpretation or implementation of this MOU is to be resolved by consultation between the Participants and is not to be referred to an international tribunal or third party settlement.
Nothing in this MOU limits or otherwise affects the rights or obligations of the United States of America or of Australia under the Agreement establishing the World Trade Organization and its Annexes, including the Agreement on the Application of Sanitary and Phytosanitary Measures, or the rights and obligations under the Australia – United States Free Trade Agreement, or any other agreement of the Participants.
IN WITNESS WHEREOF the undersigned have signed this MOU.
For the United States Food and Drug Administration Department of Health and Human Services: /s/ _________________________________
Date: Sep 23, 2005 Place: Rockville, Maryland |
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For the Australian Pesticides and Veterinary Medicines Authority:
/s/ __________________________________
Date: 20 October 2005 Place: Canberra, Australia
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