EMA: Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic/hybrid applications

This document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the course of Pre-Submission Meetings. The Agency emphasises the importance of Pre-Submission Meetings with applicants. Pre-Submission Meetings (which should take place approximately 6 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. This guidance information and successful Pre-Submission Meetings should enable applicants to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated speedily. Pre-Submission Meetings will also enable applicants to establish contact with the EMA staff closely involved with the application as it proceeds.