The European Medicines Agency EMA maintains a questions-and-answers list in which questions are clarified that are important in the context of the submission of an application for a marketing authorisation under the Centralised System. These FAQs are complemented or revised at irregular intervals or when the occasion arises. Not long ago 5 new questions were added to this list:
This list consists of a total of 53 questions/answers and covers the essential topics in connection with the submission of an application for a marketing authorisation under the Centralised System. On the EMA website, this Q&A document can be found under the sections "Human Medicines" - "Application Procedures" - "Pre-submission Guidance" - "Questions & Answers". This link leads you directly to the document.
For enquiries during the preparation phase for the application for a marketing authorisation under the Centralised Procedure, the EMA has also published additional explanations, a mandatory pre-submission request form and an application form for a pre-submission meeting. The forms are also available in the section "Pre-submission Guidance" with corresponding links. The "Explanatory Note on the Pre-submission Request Form" can be found here.
Dr Gerhard Becker
On behalf of the European Compliance Academy (ECA)