Europe – EMA : 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.
It will be updated regularly to reflect new developments, to include guidance on further preauthorisation procedures and to reflect the implementation of the new European legislation. Revised topics will be marked by “New” or “Rev” upon publication.
The Agency 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. The product team is available to address any questions MAHs may have regarding their pre-authorisation application.
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.
To obtain the information on a certain topic, simply click on the question. We trust that the
information, linked to the question, answers most of your queries. However, since each application has its own particularities we strongly encourage applicants to ask for a Pre-Submission Meeting…