Europa PDF

The electronic forms and supporting technical documentation are available europa PDF. Previous news can be found here.


Författare: .

This new version is a hotfix release of the forms and can be used as of 28th September 2018. 1 after a transitional period, on 15 October 2018 as detailed in the eAF Release Milestone plan. The version of the form should not be changed during an ongoing procedure. There is no impact to the Variation application form. This release includes further integration with OMS for organisation data in proposed and present part of Variation form and other NTA changes. 1 after transitional period, on 15 October 2018.

A feedback form for consolidated comments will be provided to you following your registration. Please follow Summary of changes, document which shows clearly before and after areas and changes to eAF that focus on test scenarios for current UAT. Please note that applicants should use Adobe Reader or Adobe Reader DC for locking the forms. Note: The milestones for the planned mandatory use of OMS within the eAF and CESP Dataset Module are currently under review and will be published soon. How to complete an eAF based on version 1.

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. 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. The EU is active in a wide range of topics, from human rights to transport and trade.

Click on a topic title below for a summary of what the EU does in that area, and for useful links to relevant bodies, laws and documents. The electronic forms and supporting technical documentation are available below. Previous news can be found here. This new version is a hotfix release of the forms and can be used as of 28th September 2018. 1 after a transitional period, on 15 October 2018 as detailed in the eAF Release Milestone plan.

The version of the form should not be changed during an ongoing procedure. There is no impact to the Variation application form. This release includes further integration with OMS for organisation data in proposed and present part of Variation form and other NTA changes. 1 after transitional period, on 15 October 2018. A feedback form for consolidated comments will be provided to you following your registration.

Please follow Summary of changes, document which shows clearly before and after areas and changes to eAF that focus on test scenarios for current UAT. Please note that applicants should use Adobe Reader or Adobe Reader DC for locking the forms. Note: The milestones for the planned mandatory use of OMS within the eAF and CESP Dataset Module are currently under review and will be published soon. How to complete an eAF based on version 1.