FDA - COFEPRIS
Confidentiality Commitment of the Food and Drug Administration
of the United States of America (FDA) regarding Non-Public Information Furnished
by the Federal Commission for Protection against Health Risks
of the United Mexican States (COFEPRlS)
Whereas, in accordance with the Cooperative Arrangement signed on September 4, 2001, among the Department of Health and Human Services and the Department of Agriculture of the United States of America AND the Secretariat of Health and the· Secretariat of Agriculture, Livestock, Rural Development, Fisheries, and Food Products of the United Mexican States to strengthen cooperative activities of mutual interest in the area of the safety of foods for human consumption, the Federal Commission for Protection against Health Risks (COFEPRIS) may share confidential information regarding the safety, effectiveness, or quality of products with the Food and Drug Administration (FDA);
Recognizing that such information is shared in the interest of public health and furnished solely to implement cooperative law enforcement or regulatory efforts between COFEPRIS and the FDA;
On the understanding that non-pUblic information such as confidential commercial or trade secret information, personal privacy information, predecisional information, or other non-public informtion cannot be disseminated publicly under the laws and regulations of the United Mexican States and, accordingly, that COFEPRlS considers it of the utmost importance that the FDA undertake to safeguard the confidentiality of such information; and
Whereas COFEPRIS shall first comply with its own regulatory procedures before sharing such non-public information with the FDA, and that COFEPRIS may, at any time, take steps to recover such information from the FDA, and that any subsequent disclosure thereof shall be safeguarded under the laws of the United Mexican States;
The FDA hereby states that:
- It has the necessary authority and means to prevent the disclosure of non-public information furnished by COFEPRIS;
- Upon request, it can provide copies of statutes, regulations, legal decisions, or any other relevant document establishing the authority referred to in the preceding paragraph;
- It shall not disclose the non-public information without written authorization from COFEPRIS. As applicable, the FDA shall notify COFEPRIS within 48 hours of any action taken to obtain such information from it, whether by summons, injunction, or any other mandatory procedure, including a request based on any law akin to the Freedom of Information Act. The foregoing notwithstanding, the FDA may provide such information to the appropriate legal authority in the event of an order to that effect, provided that the FDA has taken legal measures beforehand to guarantee that said information is revealed in such a manner that it remains protected from public disclosure, and that it has notified COFEPRIS to that effect; and
- It shall notify COFEPRIS in a timely manner of any amendments to its laws, policies, or procedures that may effect its capacity to maintain the confidentiality of information shared by CO FEPRIS.
Signed at Rockville, MD on this 21st day of August 2002, in quadruplicate: two copies each in the English and Spanish languages, respectively.
Name and title of the person signing on behalf of the FDA:
Murray M. Lumpkin, M.D.
Senior Associate Commissioner for International Activities and Strategic Initiatives
Address: 5600 Fishers Lane
Rockville, MD 20857