Marketing authorisation guidance documents
This page lists documents and forms applicants may need for the preparation of their marketing authorisation application with the European Medicines Agency (EMA).
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
- Guideline on the acceptability of names for human medicinal products processed through the centralised procedure
- Name Review Group form
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
Application dossier - ICH M 4 common technical document (CTD) for the registration of pharmaceuticals for human use
Notice to applicants
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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Validation issues frequently seen with initial marketing authorisation holders (PDF/268.35 KB)
First published: 11/12/2017
Last updated: 10/08/2020
EMA/454165/2015 Rev. 1.1 -
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Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency, and paediatric rewards (PDF/133.13 KB)
Adopted
First published: 08/03/2011
Last updated: 21/01/2015
Legal effective date: 08/06/2011
EMA/PDCO/179892/2011 Rev. 2
Evaluation
- Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004
- Guideline on the scientific application and the practical arrangements necessary to implement Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004
- Time allowed for applicants to respond to questions and issues raised during the assessment of new marketing authorisation applications in the centralised procedure
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Guidance to applicants/marketing authorisation holders on oral explanations at European Medicines Agency (PDF/147.24 KB)
First published: 16/04/2015
Last updated: 08/08/2023
EMA/748003/2014 Rev.2 -
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Guidance on meetings with applicants on the responses to questions received from European Medicines Agency scientific Committees during the evaluation within the centralised procedure (PDF/258.83 KB)
Adopted
First published: 09/02/2015
Last updated: 09/02/2015
Legal effective date: 01/02/2015
EMA/636600/2014 -
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Guideline on procedures for the granting of a marketing authorisation under exceptional circumstances, pursuant to article 14 (8) of Regulation (EC) No 726/2004 (PDF/55.38 KB)
Adopted
First published: 15/12/2005
Last updated: 15/12/2005
Legal effective date: 16/12/2005
EMEA/357981/2005 -
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Guideline on legal status for the supply to the patient of centrally authorised medicinal products (PDF/65.08 KB)
Adopted
First published: 26/07/2006
Last updated: 26/07/2006
Legal effective date: 15/08/2006
EMEA/186279/2006