STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT FROM
THE ADMINISTRACIÓN NACIONAL DE MEDICAMENTOS, ALIMENTOS Y TECNOLOGÍA MÉDICA - ANMAT
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
BY
THE UNITED STATES FOOD AND DRUG ADMINISTRATION

The United States Food and Drug Administration (FDA) is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica – ANMAT (National Administration of Drugs, Food and Medical Devices regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

ANMAT understands that some of the information it receives from FDA may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. ANMAT understands that this non-public information is shared in confidence and that FDA considers it critical that ANMAT maintain the confidentiality of the information. Public disclosure of this information by ANMAT could seriously jeopardize any further scientific and regulatory interactions between FDA and ANMAT. FDA will advise ANMAT of the non-public status of the information at the time that the information is shared.

Therefore, ANMAT certifies that it:

1. has the authority to protect from public disclosure such non-public information provided to ANMAT in confidence by FDA;
2. will not publicly disclose such FDA-provided non-public information without the written authorization of the owner of the information, the written authorization from the individual who is the subject of the personal privacy information, or a written statement from FDA that the information no longer has non-public status;
3. will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from ANMAT. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, ANMAT will take all appropriate legal measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and
4. will promptly inform FDA of any changes to Argentine Republic’s laws, or to any relevant policies or procedures, that would affect ANMAT’s ability to honor the commitments in this document.

Signature of foreign agency official