Title 21: Food and Drugs
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/ 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 / § 26.64 Transitional arrangements.
§ 26.64 Transitional arrangements.
The parties agree to implement the transitional commitments on confidence building as specified in subparts A and B of this part.
(a) The parties agree that each sectoral transitional arrangement shall specify a time period for completion.
(b) The parties may amend any transitional arrangement by mutual agreement.
(c) Passage from the transitional phase to the operational phase shall proceed as specified in subparts A and B of this part, unless either party documents that the conditions provided in such subpart for a successful transition are not met.