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).

Also on this topic

• Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance
• Marketing authorisation templates
• Post opinion: Regulatory and procedural guidance
• Standard for exchange of non-clinical data (SEND): proof-of-concept study

Pre-submission

General

• Pre-submission request form

Procedural advice to CHMP members

Adopted Reference Number: EMEA/361945/2007

Eligibility

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

Adopted Reference Number: EMEA/CHMP/121944/2007

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 for Article 58 scientific opinion application submissions

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

Adopted Reference Number: EMA/151751/2010 Rev.4

Standard operating procedure for CHMP rapporteur / co-rapporteur appointment for Community procedures

Adopted Reference Number: SOP/H/3176 Legal effective date: 25/09/2012

Deadlines

See question 'What are the submission dates for rapporteur appointment requests?' on the pre-authorisation guidance page

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

Adopted Reference Number: CPMP/ICH/1840/01 Legal effective date: 01/05/2004

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

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 for marketing authorisation (MA)

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

Reference Number: EMA/454165/2015 Rev. 1.1

Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency, and paediatric rewards

Adopted Reference Number: EMA/PDCO/179892/2011 Rev. 2 Legal effective date: 08/06/2011

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

Guidance to applicants/marketing authorisation holders on oral explanations at European Medicines Agency

Reference Number: EMA/748003/2014 Rev.2

Guidance on meetings with applicants on the responses to questions received from European Medicines Agency scientific Committees during the evaluation within the centralised procedure

Adopted Reference Number: EMA/636600/2014 Legal effective date: 01/02/2015

Guideline on procedures for the granting of a marketing authorisation under exceptional circumstances, pursuant to article 14 (8) of Regulation (EC) No 726/2004

Adopted Reference Number: EMEA/357981/2005 Legal effective date: 16/12/2005

Guideline on legal status for the supply to the patient of centrally authorised medicinal products

Adopted Reference Number: EMEA/186279/2006 Legal effective date: 15/08/2006

Withdrawals of applications

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

Adopted Reference Number: EMA/599977/2012 rev.2 Legal effective date: 01/09/2006