Contacts with Representative Organisations

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

Meeting with Interested Parties - 20 November 2024

• Minutes
• Presentations
  CMDh - SOS WG activities
  CMDh - Amended Variation Regulation
  AESGP-EUCOPE-Medicines for Europe - Implementation of the Variation Regulation
  Medicines for Europe - F-Gases and ERA
  CMDh - Zero Day MRP
  AESGP-EFPIA-Medicines for Europe - Key Information Section (KIS)

Meeting of a subgroup of CMDh with Interested Parties dedicated to the publication of outcomes of safety variations - 14 November 2024

• Minutes
• Presentations
  Safety Variation Example

Meeting with Interested Parties - 27 June 2024

• Minutes
• Presentations
  AESGP - DHPC coordination post-referral
  AESGP - Type IB variations in MRP impacting PI
  AESGP - SPOR IDMP
  Medicines for Europe - Availability of resources, Variation Regulation, Repurposing
  CMDh - Feedback from Safety Outcome Survey Working Group
  CMDh - Feedback from Multilingual Packaging Working Group

Meeting of a subgroup of CMDh with Interested Parties dedicated to LoSC and publication of PI updates - 22 February 2024

• Minutes
• Presentations
  Publication of LoSC
  Publication of safety variations

Meeting with Interested Parties - 15 November 2023

• Minutes
• Presentations
  CMDh - Multilingual Labelling in MRP/DCP
  AESGP - Variation Regulation
  EFPIA - EMRN Strategic Priorities & NCA Network Portfolio Strategy (i.e., datatechnology) Readiness
  EFPIA & Vaccines Europe - Variation Regulation
  EUCOPE - Duration of the national phase of the MRP/DCP and adherence to timelines
  EUCOPE - Variation Regulation
  Medicines for Europe - Variation Regulation and Multilingual Labelling in RUP
  CMDh - Feedback from the Safety Outcome Survey (SOS) Working Group

Meeting with Interested Parties - 31 May 2023

• Minutes
• Presentations
  CMDh - Multilingual Labelling in MRP/DCP
  CMDh - Renewal improvements
  CMDh - Availability of updated PI following safety reviews
  Medicines for Europe
  Europharm SMC

Meeting with Interested Parties on Variations - 16 May 2023

• Minutes
• Presentations
  AESGP
  EFPIA
  EUCOPE
  Medicines for Europe

Meeting with Interested Parties - 9 November 2022

• Minutes
• Presentations
  Medicines for Europe presentation
  CMDh Multilingual Packaging Group – update
  CMDh - List of safety concerns per approved RMP of active substances per product
  CMDh - Availability of updated PI following safety reviews - Follow-up of industry feedback on RSI project

Meeting with Interested Parties - 18 May 2022

• Minutes 
• Presentations
  EFPIA - EMA extended mandate - shortage reporting
  EFPIA - Inter-Association - Electronic Product Inforrmation
  Medicines for Europe -  RUP
  Medicines for Europe - Resource Planning
  Multilingual Labelling in MRP-DCP

Meeting with Interested Parties - 10 November 2021

• Minutes
• Presentations
  AESGP - National requirements related to process
  EUCOPE - Status update on Northern Ireland Protocol
  Medicines for Europe - RUP - OMS - CEP

Meeting with Interested Parties - 19 May 2021

• Minutes Correction 30/07/21
• Presentations
  CMDh Multilingual Packaging Group –update
  Medicines for Europe Presentation
  Shortened timetable MR procedure (zero-days MR procedure)
  Statistics on MRP/DCP included in the CMDh monthly press releases - proposal for simplification

Meeting with Interested Parties -  11 November 2020

• Minutes
• 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

• Minutes
• 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

• Minutes
• 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

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

Meeting with Interested Parties - 13 November 2018

• Minutes

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

Meeting with Interested Parties - 29 May 2018

• Minutes

• 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 EU ISO 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

• Minutes

• 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

• Minutes
• 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

• Minutes
• 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

• Minutes
• 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

• Minutes
• 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

• Minutes
• 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

• Minutes

• 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

• Minutes

• 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 - Feedback on Concerned Member States (CMS) delays
  EGA  - Presentation
  

CMDh meeting with Interested Parties - 19 May 2015

• Minutes
• 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

• Minutes
• 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

• Minutes
• 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

• Minutes (November 2012) 

Meeting with Interested Parties - 12 November 2012

• Minutes (November 2012)

• Presentations
  AESGP
  EFPIA
  EGA

Meeting with Interested Parties - 21 May 2012

• Minutes (May 2012)

• 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

• Minutes (January 2012)

• 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)

Meeting with Interested Parties - 20 June 2011

• Minutes (June 2011)

• 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

• Minutes (January 2011)

• 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

• Minutes (November 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)

Meeting with Interested Parties - 21st June 2010

• 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)

Meeting with Interested Parties - 16th November 2009

• Minutes (January 2010)

• 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)

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

• Minutes (November 2009)

Meeting with Interested Parties - 16th December 2008

• Minutes (January 2009)
  

Meeting with Interested Parties - 12th November 2007

• Minutes (February 2008)
  

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

• Minutes (October 2007)
  

Meeting with Interested Parties - 13th November 2006

• Minutes (November 2006)