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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
The document is structured into five sections. The first presents the key experiences and challenges that justify a renewal of the EPHFs. The second section updates the groundwork for the exercise of public health and provides a framework to inform the exercise of the new essential functions. The th ... more
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