The revised "Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs" (PA/PH/CEP (04) 2, 4R) has been applicable since 1 March 2010.
Since the new procedures for revisions were implemented, a significant number of notifications have been received and the EDQM has found a significant proportion to be incomplete. The deficiencies are generally of an administrative nature and, therefore, could be easily avoided.
The most common deficiencies noted are:
Applicants are therefore reminded that it is their responsibility to:
The procedure for treatment of notifications does not provide for the possibility of applicants sending additional information in cases of incomplete submissions.
Applicants should be aware that, in order to make the procedure efficient, from now on if the conditions for a notification are not met, or if the documentation submitted is incomplete, the notifications will be rejected and the relevant fee will be invoiced. Therefore, a new and appropriate data package will have to be submitted and the requisite fee paid.
Due to a change in the invoicing process, the following documents have been updated:
Source: Certification of Suitability to the Monographs of the European Pharmacopoeia: News & General Information
Note: The CEP procedure will be discussed in detail on the ECA Course "CTD, CEP and ASMF" on 23-24 March 2011 in Vienna. The Head of EDQM's Certification Division, Ms Hélène Bruguera, is one of the speakers of this course.