Improving quality of submissions

To assist applicants preparing their submissions, the European Medicines Agency (EMA) has published pre-submission checklists for certain procedure types.

These checklists enable applicants to submit high quality applications that avoid frequent mistakes and comply with the legal and regulatory requirements, ensuring submissions can be validated speedily. They are part of the Agency's commitment to operational excellence.

Procedure typeChecklist
  • Type IA and IB variations
PDF icon Practical guidance on the application form for centralised type IA and IB variations
  • Type IA/IAIN variations
PDF icon Pre-notification check for type IA/IAIN Variations
  • Type IA and Type IB product information annexes
PDF icon Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable)
  • Type IB Variations

PDF icon Pre-notification check for type IB Variations

  • Type II variations

File Validation checklist for Type II quality variations

 

File Validation checklist for Type II (non) clinical variations

  • All types of variations
PDF icon Guidance for applicants for the preparation of the precise scope section of the variation application form
  • Type IAIN and Type IB
Microsoft Office document icon Checklist for requesting new EU sub-numbers (Type IA Microsoft Office document icon IN Microsoft Office document icon and Type IB lead procedures only)
  • 5-year renewal applications
PDF icon Pre-submission checklist for 5-year renewal applications
  • Conditional marketing authorisation annual renewal
PDF icon Pre-submission checklist for annual renewal of conditional marketing authorisation applications
  • Exceptional circumstances marketing authorisation annual re-assessment
PDF icon Pre-submission checklist for annual re-assessment of a marketing authorisation under exceptional circumstances application

The Agency strongly recommends applicants use these checklists while preparing their dossiers and before submitting their application.

In case of any questions, they should contact their procedure manager where appointed or send a query to the Agency via the pre-submission query service.

However, applicants using the checklists may still need to submit further information during the review of the submitted application if EMA identifies other issues that could impact the outcome of the validation/procedure. Applicants should always refer the relevant European Union legislation (see: Eudralex).

Improving the submission process

EMA monitors the quality of received applications in order to identify necessary process improvements, actions and updates to the published guidance documents.

The checklists are in line with the objectives agreed as part of the PDF icon EU Medicines Agencies Network Strategy to 2020 .

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