The EDQM has revised the “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs”.
Following are the modifications.
Revised the guidelines according to European guideline on variations to marketing authorisation applications.
The structure of the guidance document has also been modified.
As a consequence, the document procedure for revision and renewal management and application forms are updated.
The revised documents have an implementation date of 01 September 2013.BACK