REQUIREMENTS FOR THE IMMEDIATE RELEASE OF PRODUCTS COVERED BY THE FDA AT THE BUREAU OF CUSTOMS
Effective September 15, 2013, the Food and Drug Administration (FDA) will no longer issue letters of clearance or certifications for the Bureau of Customs (BOC) in order to release imported product and raw materials under the jurisdiction of the FDA.
The FDA letter of clearance or certification will no longer be a requirement or condition for the immediate release of finished products for as long as the importer is able to present or submit valid FDA License to Operate and valid Certificate of Product Registration or Notification. However, for raw materials, including ingredients and additives that are used for producing or processing finished products, the following shall be presented or submitted to the Bureau of Customs for immediate release:
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