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
• Dossier submission
• Application and evaluation

Pre-submission

General

• Pre-submission request form
• Procedural advice to CHMP members

Eligibility

• Scientific aspects and working definitions for the mandatory scope of the centralised procedure

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

• Pre-submission meeting request form

Rapporteur/Co-Rapporteur appointment

• 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
• Standard operating procedure for CHMP rapporteur / co-rapporteur / peer-reviewer appointment in the centralised procedure
• 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

• 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

• ICH: M 2: Electronic common technical document (e-CTD) - Step 5

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

• Application form - user guide for the electronic application form for a marketing authorisation

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

Validation

• Validation issues frequently seen with initial marketing authorisation holders
• Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency, and paediatric rewards

Evaluation

• 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
• Guidance on meetings with applicants on the responses to questions received from European Medicines Agency scientific Committees during the evaluation within the centralised procedure
• 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
• Guideline on legal status for the supply to the patient of centrally authorised medicinal products

Withdrawals of applications

• Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products