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 Code of Federal Regulations (Last Updated: May 6, 2024)
 Title 21 - Food and Drugs
 Chapter I - Food and Drug Administration, Department of Health and Human Services
 SubChapter A - General
 Part 26 - Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
 Subpart C - “Framework” Provisions

  § 26.75 - Suspension of recognition obligations.  

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  • § 26.75 Suspension of recognition obligations.

    Either party may suspend its obligations under subpart A or B of this part, in whole or in part, if:

    (a) A party suffers a loss of market access for the party's products within the scope of subpart A or B of this part as a result of the failure of the other party to fulfill its obligations under this part;

    (b) The adoption of new or additional conformity assessment requirements as referenced in § 26.73(e) results in a loss of market access for the party's products within the scope of subpart B of this part because conformity assessment bodies (CAB's) designated by the party in order to meet such requirements have not been recognized by the party implementing the requirements; or

    (c) The other party fails to maintain legal and regulatory authorities capable of implementing the provisions of this part.