1.

Without prejudice to Article 23, the competent authority of a Member State or, in the case of a Union authorisation, the Commission shall at any time cancel or amend an authorisation it has granted where it considers that: the conditions referred to in Article 19 or, where relevant, in Article 25 are not satisfied; the authorisation was granted on the basis of false or misleading information; or the authorisation holder has failed to comply with its obligations under the authorisation or this Regulation.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.