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).
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
- 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
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Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004
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Standard operating procedure for CHMP rapporteur / co-rapporteur / peer-reviewer appointment in the centralised procedure
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Standard operating procedure for CHMP rapporteur / co-rapporteur appointment for Community procedures
Deadlines
See question 'What are the submission dates for rapporteur appointment requests?' on the pre-authorisation guidance page
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
- Practical guidelines relating to non-eCTD electronic submissions
- EMEA implementation of electronic submissions: statements of intent
Application and evaluation
Application
Notice to applicants
Notice to Applicants - Volume 2B - Presentation and content of the dossier - Electronic application form: new application
Validation
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Validation issues frequently seen with initial marketing authorisation holders
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Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency, and paediatric rewards
Evaluation
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Guidance to applicants/marketing authorisation holders on oral explanations at the European Medicines Agency
- 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 on meetings with applicants on the responses to questions received from European Medicines Agency scientific Committees during the evaluation within the centralised procedure
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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
- 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
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Guideline on legal status for the supply to the patient of centrally authorised medicinal products