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Answer:
With the implementation of CEP 2.0 the conditions triggering the issuance of a revised CEP have been modified. A CEP is always revised in the following cases:
- 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 After any notification/minor/major/monograph revisions impacting the content of the CEP.
- After assessment of renewal application containing changes which impact the content of the CEP.
- Upon request of applicants applying for a switch of their CEP to CEP 2.0 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.