TOPICS : 07- CERTIFICATION OF PHARMACEUTICAL SUBSTANCES / 02- REVISIONS/ RENEWALS 

• 01. When should the applicant request a renewal?

• 02. When is a CEP revised?

• 03. What kind of “Minor Changes to the Manufacturing Process” are considered as “minor changes by default” according to the EDQM Guideline on Requirements for Revisions / Renewals of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2)?

• 04. What “Minor Changes to the Manufacturing Process” may be submitted to EDQM through a notification according to the EDQM Guideline on Requirements for Revisions/Renewals of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2)?


 
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