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
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
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
Application and evaluation
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