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GM2 21.B.65 Suspension, limitation and revocation

ED Decision 2023/014/R

LINK BETWEEN FINDINGS AND SUSPENSION OR LIMITATION OR REVOCATION

The levelΒ 1 findings are those which may lead, if not properly addressed, to suspension, limitation or revocation of the approval. If appropriate, these negative decisions on the approval may be taken immediately, or after the organisation fails to comply within the time period agreed by the competent authority.

The type of the negative decision β€” i.e. suspension, limitation or revocation β€” should depend upon the contents and the extent of the level 1 finding. Normally, a limitation or a suspension should be considered first.