Cmdh Slot Request Form

The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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. HMA and CMDh/v are in the process of making appropriate changes to this website. If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. In case you notice information that should be updated, please report this website link using the contact form.

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

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

• Recommendations on contacts with Representative Organisations(March 2017) [Track version]

Meeting with Interested Parties - 11 November 2020

• Presentations
  Vaccines Europe - COVID-19 Vaccines EMA regulatory pathway and options for national emergency use;
  EFPIA - COVID-19 regulatory flexibilities survey;
  CMDh - Reference safety information;
  Medicines for Europe - Multilingual/Multinational Labelling;
  CMDh Multilingual Packaging Group update;
  AESGP - Splitting of MRP/DCP;

Meeting with Interested Parties - 27 May 2020

• Presentations
  EFPIA - COVID user testing guidance
  EuropaBio - nitrosamine impurities and data submissions
  IE - CMDh update on Multilingual Packaging Group for IP meeting
  Medicines for Europe - RSI position paper
  Medicines for Europe - COVID
  Medicines for Europe - Multilingual - May 2020 BS
  Vaccines Europe - MDR

Meeting with Interested parties - 13 November 2019

• Presentations
  AESGP - Results of the 2019 AESGP Survey on MRP-DCP for non-prescription medicines;
  Medicines for Europe / EFPIA / AESGP - Presentation;
  Medicines for Europe / EFPIA - Multilingual labelling - Practise across Europe;
  CMDh - Brexit update;
  CMDh - BPG on Multilingual Packaging;
  CMDh - Harmonisation of RMP Project (HaRP): CMDh project to harmonise RMPs of products with the same active substance - State of the art and next step;

Meeting with Interested Parties - 28 May 2019

• Presentations
  Brexit update
  ASMF Worksharing
  EFPIA - ePI development of key-principles
  Medicines for Europe Presentation

Meeting with Interested Parties - 13 November 2018

• Presentations
  Joint Industry presentation
  Use of variation worksharing
  CEP update
  Brexit update

Meeting with Interested Parties - 29 May 2018 Oktoberfest darwin casino 2019 rooms.

• Presentations
  CMDh - Parallel national MA Application
  CMDh - Worksharing compliance
  Medicines for Europe - Worksharing procedure variations
  Medicines for Europe Presentation
  Joint IPs Presentation - Support and Concerns for EUISO IDMP/ SPOR
  Medicines for Europe - Annex 2 to Excipients in labelling and package leaflet of medicinal products for human use
  AESGP - PSUSA outcomes

Meeting with Interested Parties - 7 November 2017

• Presentations
  Medicine for Europe Presentation
  Medicines for Europe - QP Intermediates
  Colours in medicines
  EFPIA - Survey underlines the importance of action on medicines to prevent patients being put at risk as a result of Brexit
  PSUFU
  EU eSubmission Roadmap

Meeting with Interested Parties - 16 May 2017

• Presentations
  Agreeing the product name during DCP
  BREXIT preparations
  EFPIA - Implementation of falsified medicined directive
  Medicines for Europe Presentation
  Availability of paediatric medicines
  Publication of CMDh feedback given to queries
  eSubmissions update

Meeting with Interested Parties - 8 November 2016

• Presentations
  EFPIA - Article 57 database
  Administrative simplification
  AESGP - Analysis of the Questionnaires on authorisation & registration of herbals in the EU/ MRP and DCP
  Medicines for Europe
  AESGP - Analysis of the Responses on the Questionnaire on API- MIX

Meeting with Interested Parties on MRP/DCP Improvements - 7 November 2016

• Presentations
  AESGP - Pilot on Merging and Splitting of MRP/DCPs
  Worksharing DCP
  MRP and RUP timetable
  Medicines for Europe - DCP improvement

Meeting with Interested Parties on MRP/DCP Improvements - 23 May 2016

• Presentations
  Pilot on Merging and Splitting of MRP/DCPs
  Updates of SOP on DCP
  Repeat-use procedures
  Medicines for Europe - DCP improvement
  EFPIA - MRP and national licenses
  Variations
  

CMDh meeting with Interested Parties - 24 May 2016

• Presentations
  CMDh strategy to 2020 and CMDh workplan
  EFPIA - Extended Environmental Risk Assessment scheme
  Paediatric issues
  Electronic Submissions
  Variations
  AESGP - API mixtures
  Medicines for Europe

Meeting with Interested Parties on MRP/DCP Improvements - 16 November 2015

• Presentations
  EGA - Presentation on improvement of DCP
  EGA - Proposal for merging
  Change of future MAH
  Managing the clockstop
  HMA Taskforce on adherence to timetables
  Merging and splitting
  MRP RUP
  Q&A on QP declaration
  Worksharing DCP

CMDh meeting with Interested Parties - 17 November 2015

• Presentations
  EFPIA - Regulatory Pathways - 2D barcodes and Tamper Evident Seals or 'Anti-tampering Device'
  EGA - Presentation
  CMDh Strategy
  eSubmission
  PSUR repository
  Regulatory non-compliance
  Variations
  Variations worksharing

Meeting with Interested Parties on DCP/MRP Improvements - 18 May 2015

• Minutes
  
• Presentations
  AESGP - Split procedures. An OTC industry perspective
  AESGP - Results of the Survey on MRP-DCP for non-prescription medicines
  EFPIA - Change of Marketing Authorisation Holder (MAH) during MRP/DCP
  EFPIA - EGA - Presentation
  

Poker table stencils. CMDh meeting with Interested Parties - 19 May 2015

• Presentations
  AESGP - Harmonised implementation of risk minimisation measures in the context of the referral procedures

  AESGP - Variation classification of regular updates of SmPC and PIL as regards adverse effects
  EFPIA - Type IA variation label implementation guidance
  EGA - Presentation
  EFPIA - Further use of sRUP (Simplified Repeat Use Procedure) in Croatia
  AESGP - Q&A on API-mixtures. An unresolved regulatory problem

CMDh meeting with Interested Parties - 18 November 2014

• Presentations
  EFPIA - Challenges with national WS procedures
  EGA - Presentation and Position paper on API Supply chain
  EUCOPE - Signal detection procedures and Implementation of the EC Decision or CMDh agreement (Article 31 or 107i)
  Paediatrics

Meeting with Interested Parties on ASMF - 18 November 2014

• Presentations
  APIC - ASMF Procedures
  EFPIA - Presentation
  Submision Criteria for ASMF
  Feedback on the ASMF-AR worksharing pilot phase and future plans
  How to deal with ASMF updates

Meeting with Interested Parties on DCP/MRP Improvements - 17 November 2014

• Presentations
  AESGP - Escher Project
  EGA - Presentation

Meeting with Interested Parties - 20 May 2014

• Minutes
  
• Presentations
  AESGP - Implementation of referral outcomes
  EFPIA - CMDh Position Paper on QR codes
  EFPIA - Multi-MAH complexity on implementation of PRAC measures
  EFPIA - Raising public health concerns after first round of questions
  EFPIA - Update on the pilot on work-sharing procedures for ASMF assessment
  EGA - Presentation to IP meeting
  EUCOPE - Experience from translation processes for referrals and signal detection procedures
  CMDh Position Paper on QR codes
  New applications - Need for core RMP

Meeting with Interested Parties on DCP/MRP improvements - 19 May 2014

• Minutes
  
• Presentations
  Joint Interested Parties presentation
  Response from CMDh to questions raised in November 2013
  Validation - template for setting day -14
  National phase
  National implementation in NL
  Variations and Renewals
  eSubmissions

Meeting with Interested Parties - 18 November 2013

• Minutes[tracked]

• Presentations
  AESG
  EFPIA
  EGA
  Managing the DCP Clockstop
  Responses from CMDh to proposals from Industry
  Electronic submissions - RMS technical validation and the Roadmap

Meeting with Interested Parties on DCP/MRP improvements - 27 May 2013

• Presentations
  EGA
  EFPIA
  Validation
  Managing the Clock-stop
  National phase

Meeting with Interested Parties - 27 May 2013

• Minutes
  
• Presentations
  EGA
  EFPIA
  EUCOPE
  ASMF Worksharing pilot phase

Meeting with Interested Parties on DCP/MRP Improvements - 12 November 2012

Meeting with Interested Parties - 12 November 2012

• Presentations
  AESGP
  EFPIA
  EGA

• Presentations
  Item 2 - Best Practice Guide on the submission of Quality translations
  Item 3 - Implementation of Variations: Availability of the latest info for patients/users
  Item 4 - Packaging for small volume medicinal products

Meeting with Interested Parties - 14 November 2011

• Presentations
Item 2 – Revision of CMDh automatic validation of MR/Repeat use/DC Procedures (AESGP Comments)
Item 2 – Open consultation on technical validation (SE)
Item 3 – Implementation of the outcome of the Paediatric Worksharing (AT)
Item 5 – Transfer of Chapter 7 from EC to CMDh (EMA)
Item 6 – Presentation on the status of the ASMF-project as at November 2011

Meeting with Interested Parties on the Self-Medication Project - 20 June 2011

• Presentations
  Item 1 Introductory slides (UK)
  Item 2 Specific MRP-DCP issues for the licensing of OTC medicines (AESGP)
  Item 3 Industry-led items in the Self-Medication project work plan (AESGP)

• Presentations
  Item 2 Improvement of DCP (EGA)
  Item 2 Improvement of DCP (AESGP)
  Item 3 Slot booking and cancellation (EGA)
  Item 3 Slot booking and cancellation (FR)
  Item 3 Slot booking and cancellation (AESGP)
  Item 4 National translation - national phase (AESGP)
  Item 4 National Translation - national phase (EGA)
  Item 5 DDPS declaration form (NL)
  Item 7 Purely national procedures (AESGP)

Meeting with Interested Parties - 15th November 2010

• Presentations
  Item 2 CMDh contribution to TF on ressources (AESGP)
  Item 2 CMDh contribution to TF on ressources (EFPIA)
  Item 2 CMDh contribution to TF on ressources (EGA)
  Item 2 CMDh Timeslot survey (AESGP)
  Item 3 Variations (EFPIA)
  Item 3 Variations (EGA)
  Item 3 Variations (CMDh)
  Item 4 Practical elements for harmonisation after Art.30 referral procedure (EFPIA)
  Item 4 Practical elements for harmonisation after Art.30 referral procedure (EGA)
  Item 5 ASMF (EGA)
  Item 5 ASMF (CMDh)
  Item 6 National switch in EU procedure (AESGP)
  Item 7 Survey on CPPs (AESGP)

Meeting with Interested Parties on Paediatric Regulation - 20th September 2010

• Presentations
  Item 2 Article 45 Worksharing (EFPIA)
  Item 2 Article 45 Worksharing (EGA)
  Item 2 Article 45 Worksharing (CMDh)
  Item 3 Article 46 Worksharing (EFPIA)
  Item 3 Article 46 Worksharing (EGA)
  Item 3 Article 46 Worksharing (CMDh)
  Item 4 Article 29 of Paediatric Regulation (EFPIA)
  Item 4 Article 29 of Paediatric Regulation (EGA)
  Item 4 Article 29 of Paediatric Regulation (CMDh)

Cmdh Slot Request Form Sss

• Minutes (September 2010)
  
• Presentations
  Item 2 Ressources (AESGP)
  Item 2 Ressources (EFPIA)
  Item 2 Ressources (EGA)
  Item 2 Ressources (CMDh)
  Item 3 DCP clock-stop (AESGP)
  Item 3 DCP clock-stop (CMDh)
  Item 4 Variation Regulation (EFPIA)
  Item 4 Variation Regulation (EGA)
  Item 4 Variation Regulation (CMDh)
  Item 6 Article 30 Harmonisation (EFPIA)
  Item 6 Article 45-46 Paediatric workshares (EFPIA)
  Item 6 Type IA implementation (EFPIA)
  Item 6 Survey 2010 (EGA)
Item 6 Issues encountered with Type IA implementation (AESGP)

Cmdh Slot Request Form 9465

Meeting with Interested Parties - 16th November 2009

• Presentations
  Items 2 to 5 (EFPIA)
  Item 2 Resources (EGA)
  Item 2 Resources (CMDh)
  Item 3 Electronic submissions (EGA)
  Item 3 Electronic submissions (CMDh)
  Item 4 Variations (EGA)
  Item 4 Variations (CMDh)
  Item 5 SOP on DCP (EGA)
  Item 5 SOP on DCP (CMDh)

Cmdh Slot Request Forms

Meeting with Interested Parties on Paediatric Regulation - 21st September 2009

Meeting with Interested Parties - 16th December 2008

Meeting with Interested Parties - 12th November 2007

Meeting with EGA on Worksharing for patient consultation - 19th June 2007

Meeting with Interested Parties - 13th November 2006

Cmdh Slot Request Form Template

Request for Marketing Authorisation Holders to assess the risk of occurrence of contamination with mesilate esters and related compounds in pharmaceuticals (this information should always be submitted with new applications).