The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised catalogue terms, built in business rule validation, and support for validation of form, etc. Implementation of mandatory use of the eAF is part of the HMA eSubmission roadmap.
The electronic forms and supporting technical documentation are available below.
News
Previous news can be found here.
09-01-2020
Please note that from 1 January 2020, the Formatted Table Template will no longer be maintained by EMA.
The use of the XML delivery files is mandatory and the users are required to fill in all the submission attributes correctly through the eSubmission Delivery File UI since all attributes in the delivery file are used to support important searches in the Common Repository.
The delivery file must be attached to the submission when it is sent via the eSubmission Gateway or the Web Client.
The use of XML delivery files also supports the EMA internal processes by significantly reducing the time required for receiving, processing and validating incoming applications and it ensures continuous and immediate access to up-to-date dossiers for internal and network users.
Please note that below mentioned fields are crucial and must be filled in correctly:
- Customer reference (Purchase order information) for all relevant fee related submissions
- Related procedure number for all submissions that already have a procedure number assigned
- RMP version number where applicable
- Withdrawal information for consolidating sequence unit type.
09-12-2019
Version 1.23.1.4 of the Human Marketing authorisation Application (maa) electronic Application Form (eAF) is now available. The release v1.23.1.4 is a bug fix release to correct business rules implementation in sections 1.4 and 1.5. Further details are available on the release notes. This bug fix release does not affect the Data Exchange Standard (DES). Applicants are reminded that the version of the form should not be changed during an ongoing procedure.
10-10-2019
Version 1.23.1.3 of the 4 electronic Application Forms (eAF) is now available. This release (v1.23.1.3) is a bug fix release to correct a number of issues which affect the forms. Further details are available in the release notes. This bug fix release does not affect the Data Exchange Standard (DES).
Applicants are reminded that the version of the form should not be changed during an ongoing procedure.
Forms
Please note that applicants should use Adobe Reader or Adobe Reader DC for locking the forms. Adobe Acrobat or Acrobat Pro DC should not be used for filling and locking the forms as this may cause issues when the locked forms are opened/viewed by the recipient who may be using Adobe Reader/Adobe Reader DC.
Currently accepted version of forms :
Q & A
Multimedia webinars and training
eAF Term Request Form
If you need to request a missing substance in order to complete an eAF, please submit a request for substance insertion with the corresponding SmPC to the EMA Service Desk portal.
If you need to request a new term (e.g. pharmaceutical form or unit of measurement) or a request for an update of an already existing term in order to complete the eAF, please submit a request through the SPOR Portal - http://spor.ema.europa.eu/rmswi/#/ providing as much supporting documentation as possible (e.g. name of the product concerned, SmPC, etc.). Please note you need to be registered with SPOR prior to submission of change requests: https://register.ema.europa.eu/identityiq/login.jsf. The user guide for managing referential and organisation data in eAF is available here.
Technical Documents
The Data Exchange Standards and XML Schema Definitions published here are intended to allow software developers within other organisations to develop systems to process the electronic application form data and build equivalent systems, if required. The EMA will ensure that the latest versions of these documents are published here.
Current version of technical documents:
For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu
Links
