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).

• Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance
• Post opinion: Regulatory and procedural guidance
• Marketing authorisation templates

General

• Pre-submission request form

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

• Organisation of the CTD
• Quality
• Safety
• Efficacy

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

Application for marketing authorisation (MA)

Notice to applicants

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

Validation

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

Withdrawals of applications