Contacts with Representative Organisations
Meeting with Interested Parties - 9 November 2022
Meeting with Interested Parties - 18 May 2022
Meeting with Interested Parties - 10 November 2021
Meeting with Interested Parties - 19 May 2021
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
Meeting with Interested Parties - 13 November 2018
Meeting with Interested Parties - 29 May 2018
- 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
Meeting with Interested Parties - 16 May 2017
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
CMDh meeting with Interested Parties - 24 May 2016
Meeting with Interested Parties on MRP/DCP Improvements - 16 November 2015
CMDh meeting with Interested Parties - 17 November 2015
Meeting with Interested Parties on DCP/MRP Improvements - 18 May 2015
CMDh meeting with Interested Parties - 19 May 2015
- Minutes
- Presentations
AESGP - Harmonised implementation of risk minimisation measures in the context of the referral proceduresAESGP - 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
Meeting with Interested Parties - 18 November 2013
Meeting with Interested Parties on DCP/MRP improvements - 27 May 2013
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 - 21 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
- 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
Meeting with Interested Parties - 20 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
- 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)
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
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
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).