null Revised EDQM Guidelines concerning the procedure for ‘Certification of Suitability to the monographs of the European Pharmacopoeia'

EDQM Strasbourg, France 14/12/2018

Following introduction of the revised Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopeia Monographs’ (PA/PH/CEP (04) 2, 7R corr) several EDQM policy documents have been revised and are available.

The revised EDQM ‘Guideline on sister files’ (PA/PH/CEP (09) 141 2R) takes into consideration the non-acceptability of certain changes as revisions, but for many of which a sister file application is now possible. Some examples of a ‘substantial change’ are given in the document but there is often a need for a case-by-case decision on this question. Since these questions are not necessarily always suitable for discussion via email or on the EDQM helpdesk CEP holders may wish to request a technical advice meeting prior to submission to obtain guidance and define their submission strategy. The EDQM timeline for the first time evaluation of a sister file application has been harmonised to the EDQM timeline for a major revision and is therefore reduced from 3 to 2 months.

The revised EDQM policy document ‘Management of Applications for new Certificates of Suitability and Requests for Revision or Renewal of Certificates of Suitability (PA/PH/CEP (13) 110, 2 R) introduced the reduced EDQM timeline delay for a sister file.

Finally, a specific application form has been issued and which should now be used for a sister file application.

The application form for revisions has been updated. In order to simplify a request for revision, CEP holders no longer have to tick a box to classify the proposed change(s) since the change must be declared in the comparative table and developed in the cover letter if it is not possible to do so in the comparative table. CEP holders are reminded that any undeclared changes cannot be considered as approved.

These changes will apply for applications received from January 2019 onwards and reflect the EDQM’s wish to encourage the use of the sister file procedure for some changes, in order to facilitate lifecycle management and traceability of CEP applications for all parties involved.