HMA/EMA multi-stakeholder workshop on shortages
Table of contents
The aims of the EMA and HMA workshop on the activities on medicine shortages and initiatives are to:
- inform stakeholders about the HMA/EMA Task Force activities on medicines shortages and availability and interfaces with other initiatives;
- update stakeholders on progress with the Task Force deliverables and identify areas of agreement as well as areas for further discussion;
- share stakeholders’ perspectives and (ongoing/planned) initiatives to address availability issues and discuss how these can contribute to the future deliverables of the Task Force.
HMA/EMA Task Force was established by EU regulators in 2016 to develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect the availability of medicines, in order to improve continuity of supply of human and veterinary medicines across Europe.
Day 1:
Session 1: Setting the scene
Breakout session 2A: Immunoglobulins
Breakout session 2B: Biosimilars
Breakout session 2C: Medicines for veterinary use
Day 2:
Welcome and summary of day 1
Session 3: Prevention of shortages
Session 4: Permanent withdrawals from the market
Session 5: Communication and transparency
Session 6: Work ahead to 2025
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Agenda - HMA/EMA multi-stakeholder workshop on shortages (PDF/411.02 KB)
Draft
First published: 06/02/2023
Last updated: 07/03/2023 -
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Report - HMA/EMA multi-stakeholder workshop on shortages (PDF/1.09 MB) (new)
First published: 25/05/2023 -
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Presentation - 1.2 European Medicines Agencies Network initiatives - Lorraine Nolan (HMA) (PDF/497.25 KB)
First published: 07/03/2023 -
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Presentation - 1.4 Monitoring of events and preparedness for Public Health Emergencies (PHE) - Anthony Humphreys (EMA) (PDF/540.57 KB)
First published: 07/03/2023 -
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Presentation - 1.5 What happened with the HMA-EMA Task Force on availability of authorised medicines (TF AAM) since 2018 (PDF/250.32 KB)
First published: 07/03/2023 -
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Presentation - 2A.1 Overview of immunoglobulins supply situation in the EU - Klaus Kruttwig (EMA) (PDF/313.2 KB)
First published: 07/03/2023 -
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Presentation - 2A.2 EU legislation and policy on blood and blood components - Stefaan van der Spiegel (DG SANTE, EC) (PDF/478.1 KB)
First published: 07/03/2023 -
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Presentation 2A.3 - SUPPLY Project: Availability of IV/SC human normal immunoglobulins in the EU/EEA - Fabio Candura (ISS) Daphne Thijssen-Timmer (European Blood Alliance) (PDF/1.34 MB)
First published: 08/03/2023 -
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Presentation - 2A.4 Rapporteur session - Emilija Matelytė (EMA) (PDF/367 KB)
First published: 07/03/2023 -
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Presentation - 2B Breakout session - Biosimilars - Steffen Thirstrup (EMA) (PDF/416.82 KB)
First published: 07/03/2023 -
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Presentation - 2B.1 Work plan of the HMA Biosimilar Working Group (BSWG) - Esa Heinonen (HMA) (PDF/317.03 KB)
First published: 07/03/2023 -
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Presentation - 2B.2 Scientific rationale for interchangeability of biosimilars in the EU - Elena Wolff-Holz (PEI) (PDF/1.41 MB)
First published: 07/03/2023 -
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Presentation - 2B.3 HMA-EMA statement on interchangeability of biosimilars - Steffen Thirstrup (EMA) (PDF/742.01 KB)
First published: 07/03/2023 -
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Presentation - 2B.4 Rapporteur session - Rosa Gonzalez-Quevedo (EMA) (PDF/306.41 KB)
First published: 07/03/2023 -
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Presentation - 2C.1 Medicines for veterinary use - Nancy de Briyne (FVE) (PDF/1.41 MB)
First published: 07/03/2023 -
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Presentation - 2C.2 Medicines for veterinary use - Elsa Vecino (Accessvetmed) (PDF/448.86 KB)
First published: 07/03/2023 -
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Presentation - 2C.3 Medicines for veterinary use - Rick Clayton (AnimalHealthEurope) (PDF/442.36 KB)
First published: 07/03/2023 -
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Presentation - 2C.4 Medicines for veterinary use - Paule Carnat-Gautier (ANSES) (PDF/269.11 KB)
First published: 07/03/2023 -
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Presentation - 2C.5 Medicines for veterinary use - Inke Reimer (BVL) (PDF/190.17 KB)
First published: 07/03/2023 -
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Presentation - 2C.6 Rapporteur session - Janos Kovacs (EMA) (PDF/220.79 KB)
First published: 07/03/2023 -
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Presentation - 3.1 Prevention of shortages - Ancel.la Santos (BEUC) (PDF/1.5 MB)
First published: 07/03/2023 -
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Presentation - 3.2 Prevention of shortages - Stephan Roenninger (Industry) (PDF/3.07 MB)
First published: 07/03/2023 -
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Presentation - 3.3 Prevention of shortages - Jorge Batista (PGEU) (PDF/2.22 MB)
First published: 07/03/2023 -
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Presentation - 3.4 Prevention of shortages - Nancy De Biyne (FVE) (PDF/1.15 MB)
First published: 07/03/2023 -
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Presentation - 3.5 Network priorities to 2025 TF AAM workplan - Maria-Jesus Alcaraz Tomas (EMA) (PDF/632.38 KB)
First published: 07/03/2023 -
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Presentation - 4 Permanent withdrawals of medicinal products from the market - Momir Radulovic (HMA) (PDF/167.13 KB)
First published: 07/03/2023 -
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Presentation - 4.1 Permanent withdrawals from the market - Charlotte Roffiaen (EPHA) (PDF/207.33 KB)
First published: 07/03/2023 -
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Presentation - 4.2 Permanent withdrawals from the market - Mary McCarthy (UEMO) (PDF/166.13 KB)
First published: 07/03/2023 -
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Presentation - 4.3 Permanent withdrawals from the market - Adrian van den Hoven (Industry) (PDF/206.86 KB)
First published: 07/03/2023 -
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Presentation - 4.4 Permanent withdrawals from the market - Michael Ermisch (GKV-Spitzenverband) (PDF/64.6 KB)
First published: 07/03/2023 -
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Presentation - 4.5 Permanent withdrawals from the market - Matjaz Marc (JAZMP, SPOC WP) (PDF/61.14 KB)
First published: 07/03/2023 -
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Presentation - 4.6 Network priorities to 2025 - TF AAM workplan - Joao Ferreira (EMA), Michael Berntgen (EMA) (PDF/246.92 KB)
First published: 07/03/2023 -
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Presentation - 5.1 Patients’ perspective on communication and transparency - Marko KorenjaK (PCWP) (PDF/888.16 KB)
First published: 07/03/2023 -
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Presentation - 5.2 Communication and transparency - Jean-François Duliere (Industry (PDF/2.59 MB)
First published: 07/03/2023 -
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Presentation - 5.3 Communication and transparency - the Healthcare Professionals' perspective - Rosa Giuliani (HCPWP) (PDF/1.38 MB)
First published: 07/03/2023 -
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Presentation - 5.4 Shortages and communication - paralel timelines - Diego Pernas (AEMSP) (PDF/1004.9 KB)
First published: 07/03/2023 -
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Presentation - 5.5 Network priorities to 2025 - TF AAM workplan - Juan Garcia Burgos, Inga Abed (EMA) (PDF/1.08 MB)
First published: 07/03/2023