25 July 2013
The EDQM has revised the “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs” to include the new requirements of the revised European guideline on variations to marketing authorisation applications. The structure of the document has also been modified.
As a consequence, the document “Procedures for Management of Revisions/Renewals of Certificates of Suitability to the European Pharmacopoeia Monograph” and the related application form for revisions have also been updated to reflect these changes.
EDQM also wishes to enforce the use of an appropriate comparative table of changes, which is now an annex to the application form, and which should be submitted in Module 1 of the revision application.
The revised documents have an implementation date of 01 September 2013.