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  1. Confidentiality Commitments

The South African Health Products Regulatory Authority – FDA, Confidentiality Commitment

Update on South Africa regulatory agencies

 

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THESOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY 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 South African Health Products Regulatory Authority (SAHPRA) regarding FDA-regulated products as part ·of cooperative law enforcement or cooperative regulatory activities.

SAHPRA 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. SAHPRA understands that this non-public information is shared in confidence and that FDA considers it critical that SAHPRA maintain the confidentiality of the information. Public disclosure of this information by SAHPRA could seriously jeopardize any further scientific and regulatory interactions between FDA and SAHPRA. FDA will advise SAHPRA of the non-public status of the information at the time that the information is shared.

Therefore, SAHPRA certifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to SAHPRA 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 SAHPRA. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, SAHPRA 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 dis closure; and
     
  4. will promptly inform FDA of any changes to SAHPRA's laws, or to any relevant policies or procedures, that would affect SAHPRA's ability to honor the commitments in this document.

 

Signature of foreign agency official

______________/S/_______________
5/8/2018

Ms Portia Nkambule
Acting CEO, SAHPRA South Africa

Address: South African Health Products Regulatory Authority
Civitas Building
Private Bag X 828 Pretoria
0001
Telephone: +27 12 395 8126
Facsimile: 0866323793

Date

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