6/20/2013

The U.K. Medicines and Healthcare Products Regulatory Agency, concerned about potential shortages when new rules requiring regulator certificates go into effect July 2, has said that it will allow API imports lacking such written confirmation on a case-by-case basis to ensure continued supplies. Imports should still have a valid EU good manufacturing practices certificate, and drug firms will need to have audited the API manufacturing site within the past three years.

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