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 type	Checklist
Type IA and IB variations	European Medicines Agency practical guidance on the application form for centralised type IA and IB variations
Type IA/IAIN variations	Pre-notification check for type IA/IAIN variations
Type IA and Type IB product information annexes	Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - human
Type IB Variations	Pre-notification check for type IB Variations
Type II variations	Validation checklist for Type II quality variations   Validation checklist for Type II (non) clinical variations
All types of variations	Guidance for applicants for the preparation of the precise scope section of the variation application form
Type IAIN and Type IB	Checklist for requesting new EU sub-numbers (type IAIN and Type IB lead procedures only)Checklist for requesting new EU sub-numbers (type IAIN and Type IB lead procedures only)Checklist for requesting new EU sub-numbers (type IAIN and Type IB lead procedures only)
5-year renewal applications	Pre-submission checklist for 5-year renewal applications
Conditional marketing authorisation annual renewal	Pre-submission checklist for annual renewal of conditional marketing authorisation applications
Exceptional circumstances marketing authorisation annual re-assessment	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 EU Medicines Agencies Network Strategy to 2020: Working together to improve health.