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ARA.MED.245 Continuing oversight of AMEs and GMPs

Regulation (EU) 2024/2076

When developing the continuing oversight programme referred to in point ARA.GEN.305, the competent authority shall take into account:

(1) the number of AMEs and GMPs exercising their privileges within the territory where the competent authority exercises oversight;

(2) the number of AMEs certified by competent authorities of other Member States exercising their privileges within the territory where the competent authority exercises oversight;

(3) a risk-based assessment of the AMEs’ and GMPs’ activity.

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