Article 58 Q&A: Introduction

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This section of the website addresses a number of questions that users of Article 58 of Regulation (EC) No 726/2004 may have. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in pre-submission meetings.

The Agency emphasises the importance of pre-submission meetings with applicants. These meetings are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the agency. Together with the guidance in this document, successful pre-submission meetings should enable applicants to submit applications that conform to legal and regulatory requirements and that can be validated speedily. Pre-submission meetings also enable applicants to establish contact with the Agency staff who will be involved with the application as it proceeds.

For further information on the contents of this document or in case the applicants would like to contact WHO prior to the submission of an eligibility request, a request for scientific advice or an application for Article 58 of Regulation (EC) No 726/2004 to the European Medicines Agency, please send an e-mail toarticle58@ema.europa.eu andcpeligibility@ema.europa.eu.

For information on pre-submission meetings, please contact:

Product and Application Business Support (PA-BUS)
European Medicines Agency 
30 Churchill Place
Canary Wharf
London
E14 5EU
E-mail: pa-bus@ema.europa.eu

Instructions for users

To obtain the information on a certain topic, simply click on the question. Although the information in this document should answer most queries, each application has its own particularities so we strongly encourage applicants to request a pre-submission meeting.

For clarification on any of the topics below or to apply for a pre-submission meeting, please use the Pre-submission Meeting for Article 58 of Regulation (EC) 726/2004 procedure Request Form marking which topics you would like to be addressed by the agency.

When you have completed the request form, please return it by mail or e-mail.

Note

This document has been produced for guidance only and should be read in conjunction with the Guideline on procedural aspects regarding a CHMP scientific opinion in the context of co-operation with the World Health Organization (WHO) for the evaluation of medicinal products intended exclusively for markets outside the Community (EMEA/CHMP/5579/04).

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