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Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status, ... more
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The content of these guidelines goes beyond the technicalities of medical needs with additional insights into community empowerment, possible access to welfare and economic opportunities and similar issues. If these are adequately explored, the health and quality of life of people affected and their ... more