Thursday, 22 March 2018

Ph. Eur. Supplement 9.5

Supplement 9.5 of the Ph. Eur. is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of July 2018, and to follow the instructions given in the document.

The need to submit information to EDQM following a revised monograph depends on the changes made to the monograph. Updates to the monographs are classified by EDQM into “Case A” and “Case B” and this influences the information required.

For details, see EDQM.

Posted by Dr. Tim Sandle

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