STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA OF BRAZIL 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 Agência Nacional de Vigilância Sanitária of Brazil (ANVISA) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities. The FDA proposes to share non-public information regarding, among other things, the safety, effectiveness, or quality of FDA-regulated products with ANVISA.
This Commitment is intended to strengthen communication between ANVISA and the FDA to enhance their ability to protect and promote the health and safety of their respective populations with respect to products within the regulatory jurisdiction of ANVISA and the FDA.
ANVISA understands that some of the information it receives from the FDA may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. ANVISA understands that this non-public information is shared in confidence and that the FDA considers it critical that ANVISA maintain the confidentiality of the information. Public disclosure of this information by ANVISA could seriously jeopardize any further scientific and regulatory interactions between the FDA and ANVISA. The FDA will advise ANVISA of the non-public status of the information at the time that the information is shared.
Therefore, ANVISA certifies that it:
- has the authority to protect from public disclosure such non-public information provided to ANVISA in confidence by the FDA;
- 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;
- will inform the FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from ANVISA. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, ANVISA 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
- will promptly inform the FDA of any changes Brazil’s laws, or to any relevant policies or procedures, that would affect ANVISA’s ability to honor the commitments in this document.
September 24, 2010
Dirceu Raposo de Mello, Ph.D.
Address: SIA, Trecho 5, Área Especial 57 Cobertura
Brasília – DF, Brasil
Telephone: +55 61 3462-5406
Facsimile: +55 61 3462-5414