STATEMENT OF AUTHORITY
CONFIDENTIALITY COMMITMENT FROM
SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
THE UNITED STATES FOOD AND DRUG ADMINISTRATION
The United States Food and Drug Administration (FDA) is authorized under 21 C.F.R. § 20.891 to disclose non-public information to Spanish Agency of Medicines and Medical Devices (AEMPS) regarding FDA-regulated drugs, including pre- and post-market activities, as appropriate, as part of cooperative law enforcement or cooperative regulatory activities. FDA is further authorized under section 708(c) of the Federal Food, Drug, and Cosmetic Act2 to share with a foreign government, as it deems appropriate and under limited circumstances, certain types of trade secret information.
The Commissioner of Food and Drugs has certified AEMPS as having the authority and demonstrated ability to protect trade secret information from disclosure. FDA therefore may provide AEMPS with certain types of trade secret information at FDA’s discretion and upon request by AEMPS, based on the following certifications.
AEMPS understands that some of the information it receives from FDA may include non-public information exempt from public disclosure, such as commercially confidential information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. AEMPS understands that this non-public information is shared in confidence and that it is critical that AEMPS maintains the confidentiality of exchanged non-public information. Public disclosure of exchanged non-public information by AEMPS could seriously jeopardize any further scientific and regulatory interactions between AEMPS and FDA. FDA will advise AEMPS of the non-public status of the information at the time that the information is shared.
Therefore, AEMPS certifies that it:
- has the authority to protect from public disclosure such non-public information provided to AEMPS in confidence by 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 providing that the information no longer has non-public status;
- will protect trade secret information that FDA may provide from disclosure unless and until AEMPS is in possession of a written permission for disclosure by the sponsor of the information provided by FDA, or alternatively of a declaration from the Commissioner of Food and Drugs of a public health emergency under section 319 of the Public Health Service Act that is relevant to the information;
- with respect to trade secret information concerning the inspection of a drug facility, has the authority to otherwise obtain such information and will use such FDA-provided information only for civil, administrative regulatory purposes in the context of its mission;
- will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from AEMPS. If such judicial or legislative mandate requires disclosure of FDA-provided non-public information, AEMPS 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 FDA of any changes to the AEMPS laws, or to any relevant policies or procedures, that would affect AEMPS ability to honor the commitments in this document.
AEMPS understands that FDA-provided information may come to it from the European Medicines Agency (EMA) and/or the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) as a result of the Cooperation Agreement between EMA and the EU Member States Regulatory Authorities. AEMPS will protect such FDA-provided non-public information from public disclosure to the same extent that it will protect non-public information provided to it directly by FDA.
This text is not intended to create rights and obligations under international or other law.
Signed on behalf of AEMPS
Dr. Belén Crespo Sánchez-Eznarriaga
Spanish Agency of Medicines and Medical Devices
C/ Campezo 1 (edificio 8)
28022 – Madrid
1 United States Code of Federal Regulations, Title 21, section 20.89.
2 United States Code, Title 21, section 379(c).