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

Cmdh Slot Request Form 9465
Cmdh Slot Request Forms
Cmdh Slot Request Form Sss
Cmdh Slot Request Form Template

Request for Emergency Access to Waiver Services Prior to submitting a request for emergency access to waiver services the CSB should thoroughly explore the availability of slots at the CSB and if there are other resources that could be sought to support this individual. CMDh BPGs for the submission and processing of Variations in the MRP CMDh/094/2003/Rev17, O 2012 Page 4/55 Page 4/55 If reference is made to all strengths and/or pharmaceutical forms of a medicinal product the following. Aviation Slot Clearance Request/Reply (GCR)” found in the Annexes A and B respectively. 3.2 Operators or agents of non-scheduled, commercial and non-commercial, flights shall submit their slot requests to the Changi Slot Coordinator no earlier than 7 calendar days.

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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

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

Cmdh Slot Request Form 9465

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

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 cod