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Revised document published on Management of applications for new CEPs and revisions/renewals of CEPs.

Certification of suitability (CEP)
13 February 2017
Strasbourg, France

The document PA/PH/CEP (13) 110 which described the policy for assessment of CEP applications has been revised following a review of current practice.

As a result of the review, a 3-round policy has been adopted for the assessment of applications and this is reflected in the revised document. This is also consistent with other European procedures.

This policy change reflects the changing circumstances since the previous policy was adopted, in particular the increasing requirements for applicants to redefine starting materials to an earlier point in the synthetic route.

A similar policy is now applied to the assessment of requests for revisions/renewals of certificates and therefore this is incorporated in the revised document. The document PA/PH/Exp. CEP /T (04) 18, “Procedures for management of revisions/renewals of certificates of suitability to the European Pharmacopoeia monographs” has therefore been withdrawn.

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