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AMPAC
Analytical mthods for post-approval change document

Translation of "Analytical mthods for post-approval change document " (English → French) :

TERMINOLOGY
see also In-Context Translations below
analytical mthods for post-approval change document | AMPAC [Abbr.]

dossier de modification des maéthodes analytiques post-AMM | AMPAC [Abbr.]
IN-CONTEXT TRANSLATIONS
As long as it has not become a constituent part of an approved prospectus, it should be possible for the universal registration document to be amended, either voluntarily by the issuer — for example in the event of a material change in the organisation or financial situation of the issuer — or upon request by the competent authority in the context of an ex-post filing review where it is concluded that the standards of completeness, comprehensibility and consistency are not met.

Il convient de prévoir la possibilité que le document d’enregistrement universel, pour autant qu’il ne soit pas devenu une partie constitutive d’un prospectus approuvé, puisse faire l’objet d’amendements, soit volontairement par l’émetteur (par exemple, en cas de modification significative de son organisation ou de sa situation financière), soit à la demande de l’autorité compétente dans le cadre d’une revue postérieure au dépôt si les normes en matière d’exhaustivité, de ...[+++]




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Date index: 2023-06-25
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