ARA.MED.245 Continuing oversight of AMEs
and GMPs
Regulation (EU) 2024/2076
When developing the continuing oversight programme referred to in ARA.GEN.305, the competent authority shall take into account the number of AMEs and GMPs exercising their privileges within the territory where the competent authority exercises oversight.
[applicable until 12 February 2025 -
Regulation (EU) 290/2012]
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.
[applicable from 13 February
2025 - Regulation (EU) 2024/2076]
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