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

Meeting with Interested Parties - 11 November 2020

• Time Slot Request Form Thank you for your interest in cablecasting your 28- or 58-minute program on one of MNN's channels! Please submit this form if you have a completed program that you would like to have scheduled on one of MNN’s channels.
• For an arrival slot request, there is NO blank between action code and flight number. The scheduled time of arrival (STA) is stated without a blank after the airport of origin. Departure slot Format N ABC5678 09FEB09FEB 0019 1200LNZ C For a departure slot request, there HAS TO BE a blank between the action code and the flight.
• Form 18 Request to Release Information: PDF: Form 18R Request to Release Information (Registration Applications Only) PDF: Form 19 Application for Enrollment as an Agent: PDF: Form 20 Source and Application of Funds (Restricted Gaming License only) PDF: Form 21 Application to Transfer Interest: PDF: Form 27 3.015(2) Additional.

Request form for applications via the MRP with Portugal RMS Request form for applications via the MRP with Portugal RMS following CMDh recommendation adopted in October 2015 The Appendix 1 of the request must be filled and submitted along with the Request form. Request for time slot for applications via the DCP with Portugal as RMS. 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.

• 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

• 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 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

Cmdh Slot Request Form Sss

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)

Cmdh Slot Request Form Template

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)

• 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

• 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

Meeting with Interested Parties - 16th December 2008

Cmdh Slot Request Form 9465

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).

Removal of Booking Change Request

As announced on 20 October 2020 Link to announcement

With effect from 23 October (Fri), we will no longer be accepting request of changes to your bookings. The intention of facilitating a Booking Change Request for the past months is to allow climbers some time to adapt to the online booking system and lifestyle changes post Circuit Breaker. All requests for changes submitted before 22 October (Thu), 23:59 will be processed and followed up with accordingly.

Moving forward, if you have made an incorrect booking or have a change in plans, please cancel your booking before making a new booking online. Here are the various ways you can choose to make the cancellation:

On the website:

You can submit a Cancellation Request Form online (12 hours prior to your booking time slot). It will take at least 1 working day for the request to be processed and you will receive a booking cancellation email.

For the ones that have created online profiles and logged in, you can now use the “Cancel booking” button (12 hours prior to your booking time slot) under “My Recent Online Bookings” and a cancellation email will be sent to you once it has been processed.

Cmdh Slot Request Forms

On the RGPro Connect App:

If you have downloaded the RGPro Connect App and made a booking via the app, you can now use the “Cancel booking” button (12 hours prior to your booking time slot) under “My Recent Online Bookings” to cancel your booking. A cancellation email will be sent to you once it has been processed. Do note that booking records on the app may reflect bookings you have made via the app only. If the booking you would like to cancel is not reflected on the app, you can submit a Cancellation Request Form here.

A reminder that each climber can book one confirmed climbing slot per day. Late cancellations/ double bookings/ no-shows will be subjected to penalties.