Marketing authorisation guidance documents

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This page lists documents and forms applicants may need for the preparation of their marketing authorisation application with the European Medicines Agency (EMA).

Pre-submission

General

 

Eligibility

Deadlines
See question 'What are the dates for submission of eligibility requests?' on the pre-authorisation guidance page for submission of eligibility requests and dates of CHMP meetings

 

Product name

Deadlines
See question 'What are the dates for submission of (invented) name requests?' on the pre-authorisation guidance page for submission of proposed pames and dates of NRG discussion

 

Pre-submission meeting

 

Rapporteur/Co-Rapporteur appointment

Deadlines
See question 'What are the submission dates for rapporteur appointment requests?' on the pre-authorisation guidance page

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Dossier submission

 

Application dossier - ICH M 4 common technical document (CTD) for the registration of pharmaceuticals for human use

Notice to applicants
Notice to applicants - Volume 2B - Presentation and content of the dossier - Common Technical Document and questions and answers

 

Application dossier - electronic common technical document

Notice to applicants
Notice to applicants - Volume 2B - Presentation and content of the dossier - eCTD EU Module 1; Presentation and content of the dossier - Electronic application Form: new application;

 

Electronic submissions to the European Medicines Agency

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Application and evaluation

 

Application

Notice to applicants
Notice to Applicants - Volume 2B - Presentation and content of the dossier - Electronic application form: new application

 

Validation

 

Evaluation

 

Withdrawals of applications

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