21 C.F.R. § 26.75 Suspension of recognition obligations.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
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.