Contacts with Representative Organisations

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

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)

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).

• CMDh letter for MAHs for medicinal products containing active ingredients in the form of Mesilates, Isetionates, Tosilates or Besilates (February 2008)