21 C.F.R. § 26.38 Other transition period activities.
Title 21 - Food and Drugs
(a) During the transition period, the parties will jointly determine the necessary information which must be present in quality system and product evaluation reports. (b) The parties will jointly develop a notification and alert system to be used in case of defects, recalls, and other problems concerning product quality that could necessitate additional actions (e.g., inspections by the parties of the importing country) or suspension of the distribution of the product.
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 B—Specific Sector Provisions for Medical Devices
§ 26.38 Other transition period activities.
