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EMA Adopts Procedure to Deal with GMP Non-Compliance Information from Other Authorities

7:22 AM MDT | June 12, 2012 | Deepti Ramesh

The European Medicines Agency (EMA; London) says it has adopted a procedure for dealing with all circumstances of serious GMP non-compliance information originating from third country authorities and international organizations. The Information may refer to active pharmaceutical ingredients (API), finished product or investigational medicinal products (IMP) manufacturers, and quality control labs located either in Europe or elsewhere. The procedure, which was adopted in May 2012 and is expected to come into force in November 2012, is necessary to ensure a...

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