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mixins.searchInfo_searchTermReporting a qualified person under the Medicines Act

Reporting a qualified person under the Medicines Act

Source: BUS Rheinland-Pfalz

As the holder of the authorisation, you bear both the responsibility and the obligation to prove that the relevant Qualified Person is familiar with the product and, in particular, with the procedures for the manufacture and testing of the medicinal product(s).

If you report more than one Qualified Person, you need to clearly delineate the areas of responsibility. In order to assess the demarcation, you must submit the regulations that you, as the permit holder, have laid down in writing or electronically.

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