EMA: Regulatory and procedural guideline: European Medicines Agency pre-submission procedural advice for users of the centralised procedure

This guidance document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are typically addressed during the course of Pre-Submission Meetings. The EMA emphasises the importance of Pre-Submission Meetings with applicants. Pre-Submission Meetings (which should take place approximately 7 months prior to the anticipated date of submission of the application) are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the EMA.