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In instances where the title of a Ph. Eur. monograph is changed to either remove the word “anhydrous” or to clarify the degree of hydration, a stepwise approach is applied to CEPs by EDQM in order to minimise regulatory burden. Therefore, in the absence of any public safety issue, new monograph titles will be applied from the time of publication of the Ph. Eur. edition/supplement for any new CEP(s) granted but will be introduced gradually as and when existing CEPs are revised.

Please note that if there are additional changes to other aspects of the monographs, the normal “monograph revision” procedures are followed by EDQM. These other changes may necessitate revision of the certificate, whereby the new monograph title would then also be applied.

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