1. Cmdh Slot Request Forms
2. Cmdh Slot Request Form Sss

The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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.

Form to Request Schedule Slots To Change any of the information on an existing schedule slot, please fill out the following chart. You only need to fill out fields that will be changing. Opportunity title: Date of Schedule Slot to be changed (m/d/yy): New Date: New Start and End time: New Max # of Vols. By filling in your details on this page, you hereby authorize Xiaomi to call you about the installation/repair of your Xiaomi product. You also consent to receive communications from Xiaomi relating to your Xiaomi product and other promotional phone calls, messages (via WhatsApp and SMS) and emails. Requested MS to act as RMS: Intended number of CMSs (if known): Active Substance(s): ATC Code: Proposed Product Name Pharmaceutical Form(s) Strength(s) Legal basis of application: Art.8(3) Art.10(1) Art.10(3) Art.10(4) Art.10a Art.10b Art.10c Art. 16a Extension This is a duplicate of an ongoing or finalised procedure: Indicate the procedure number of the original dossier: Indicate the number. Time Slot Request Form Thank you for your interest in cablecasting your 28- or 58-minute program on one of MNN's channels! Please submit this form if you have a completed program that you would like to have scheduled on one of MNN’s channels.

News

Previous news can be found here.

02-12-2020
eAF issues with webservices fixed

The issue affecting the ‘Substance Type’ field in both, human and veterinary MAA forms has now been fixed and all the previously available substance types are now again available.

For any issues with the eAFs, please raise a call via the EMA service desk.

01-12-2020
eAF issues with webservices - Update

An issue relating to the eAF webservice update which affected availability of terms in the ‘Pharmaceutical Form’ field in all 4 forms has been fixed (Monday 30th November). All pharmaceutical forms should now be again in the eAFs. Please note that as this issue affected the webservices to the form, not the forms themselves so there is no need to change the form, just ‘update lists’ if the terms are not yet visible.

Additionally, another issue affecting the ‘Substance Type’ field in both, human and veterinary MAA forms has been detected and we are working on a further fix to solve this issue as soon as possible.

For any issues with the eAFs, please raise a call via the EMA service desk.

26-11-2020

eAF issue with webservices

An issue relating to the eAF webservice update has affected availability of terms in the ‘Pharmaceutical Form’ field in all 4 forms. We have released a fix that has partially solved the issue; however, we are aware that there are still many combined pharmaceutical forms that are currently unavailable in the eAFs. Please note that as this issue affects the webservices to the form, not the form itself, also previous versions of the form are affected.

We are working on a further fix to solve this issue as soon as possible.

For any issues with the eAFs, please raise a call via the EMA service desk.

27-10-2020
eAF v1.24.0.0 important note to users

An updated version of the variation eAF v1.24.0.0 is now available. This release which does not change the form version number, provides a fix to the Adobe backwards compatibility issue and it should solve the issues some users have experienced with the scope selection dropdown list in section 3. This version also includes a change in the form validation rules for grouping of Type IA or Type IAIN variations.

Please ensure that upon opening the eAF you ‘trust’ the form by clicking the small exclamation mark at the top of the left-hand adobe pane and then selecting the trust option from the yellow banner which will open across the top of the forms. The drop-down menu’s will not work if the form has not been trusted.

The Presentations for applicants and NCAs on the release v1.24.0.0 have been updated and are available below.

For any issues with the eAFs, for example reporting missing scopes, please raise a call via the EMA service desk.

08-10-2020

eAF v1.24.0.0 important note to users

The variation form can only be used with Adobe Reader version DC. The functionalities in variation selection drop down list in section 3 will not work with older versions (e.g. reader 2017, X or XI).
Please ensure that if you have Adobe Acrobat or Acrobat Pro2017, X or XI installed, you close all documents that have been opened using Acrobat/Acrobat Pro or documents that contain Adobe sign signature before opening the eAF using reader DC as these may prevent the drop down list of scopes in section 3 working as expected.
Please note that we are working hard to find a solution to this cross-interference issue as soon as possible.

Please ensure that upon opening the eAF you ‘trust’ the form by clicking the small exclamation mark at the top of the left-hand adobe pane and then selecting the trust option from the yellow banner which will open across the top of the forms. The drop-down menu’s will not work if the form has not been trusted.

The presentation on the release v1.24.0.0 has been updated and is available below.

For any issues with the eAFs, for example reporting missing scopes, please raise a call via the EMA service desk.

15-09-2020
Version 1.24.0.0 of all four electronic Application Forms (eAFs) is now available. The release v1.24.0.0 provides a major change in section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation). Some defects have been fixed in MAA human, MAA vet and renewal (H&V forms.
The new version is implemented with 3 months transitional period. Mandatory use of v1.24.0.0 will start on 16th December 2020.
More details can be found in the release notes and the updated Practical user guide for electronic Application Forms as well as the presentation on changes.
Please note that due to the major change in the variation form, data imports from older versions of the variation form will not work.
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 :

As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period.

Version 1.24.0.0, available for use from 15th of September, Mandatory use from 16th of December 2020

Cmdh Slot Request Forms

Cmdh Slot Request Form Sss

Version 1.23.1.3 and 1.23.1.4, available for use until 15th December 2020