this form requires adobe acrobat reader dc for windows

#This form requires adobe acrobat reader dc for windows pro#

Variation eAF v1.24.0.1 presentation on changes to users Variation eAF v1.25.0.0 presentation on changes to users Q & A Questions and Answers document on Mandatory use of OMS

Practical user guide for electronic Application Forms (eAF) for human and veterinary products in the EU.

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure.

European Medicines Agency practical guidance on the application form for centralised type IA and IB variations.

User guidance - Explanatory notes on Variation application form (Human).

User Guide for the electronic application form for a marketing authorisation (Veterinary).

User Guide for the electronic application form for a marketing authorisation (Human).

*Application form for marketing authorisation for veterinary medicinal products according to Regulation EU 2019/6 and for specific variations requiring assessment 1ġvariations requiring assessment classified as changes of active substance(s), strength, pharmaceutical form, route of administration or food-producing target species in chapter I of EMA/CMDv Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations Summary of eAF changes in current release Veterinary forms available for use from 28th January 2022.

Human forms available for use from 1st of December 2021.

#This form requires adobe acrobat reader dc for windows pro#

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.įor the UK, as from, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Please note that applicants should use Adobe Reader or Adobe Reader DC for locking the forms. The UAT has started on 19th September and will end on the 30th September 2022. Please find the September 2022 version of the DADI Human Variations Forms timeline, outlining the updated DADI BETA UAT timeframe. Please note that the release notes are not published for this minor change at this time. Please note that there is no version number change. It is strongly recommended to use this latest version (document properties date ). Please note that an updated EMA practical guidance on the eAF for Type IA and IB variations is now available and this updated version of the guide addresses the use of this important declaration. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human). There is a very limited impact to users of the forms.

Updated version of the eAF v1.26.0.0 (human variation) now availableĪn updated version 1.26.0.0 of the human variation eAFs is now available.Ī single change has been implemented to emphasize the mandatory use of OMS for centralised procedure by updating the Declaration label in the Proposed section. The electronic forms and supporting technical documentation are available below. Implementation of mandatory use of the eAF is part of the HMA eSubmission roadmap. 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. ESubmission Gateway & eSubmission Web Client