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Suite à l’implémentation du CEP 2.0, les conditions déclenchant la délivrance d’un CEP révisé ont été modifiées. Un CEP révisé sera toujours délivré dans les cas suivants :

-Suite à toute notification/révision mineure/majeure/révision de monographie impactant le contenu du CEP.

-Suite à l’évaluation du dossier de renouvellement contenant des changements qui impactent le contenu du CEP.

- Lorsque le demandeur désire switcher son CEP en CEP 2.0

A CEP is revised :

- as a result of notifications and/or minor revisions when there is an impact on its content (e.g. change in the address of the holder or manufacturing site, change to a test method appended to the certificate …).
- following a revision of the Ph. Eur. monograph when its content needs to be updated.
- after approval of a major change even if its content is not modified.

In cases where the CEP does not have to be revised, a letter is issued stating that the existing CEP remains valid after treatment of the request.