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EMA Crisis Preparedness Regulation In force since 1 March 2022

Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
32022R0123 · official text on EUR-Lex

This English text is a careful, terminology-researched translation prepared by eucite.com — not an official government translation. The German original linked above is the legally authoritative text.

Articles

Chapter I GENERAL PROVISIONS

• Article 1 — Subject Matter
• Article 2 — Definitions

Chapter II MONITORING AND MITIGATING SHORTAGES OF CRITICAL MEDICINAL PRODUCTS AND MANAGEMENT OF MAJOR EVENTS

• Article 3 — Executive Steering Group on Shortages and Safety of Medicinal Products
• Article 4 — Monitoring of events and preparedness for public health emergencies and major events
• Article 5 — Evaluation of information and provision of recommendations on action in relation to the quality, safety and efficacy of medicinal products related to public health emergencies and major events
• Article 6 — Lists of critical medicinal products and information to be provided
• Article 7 — Monitoring shortages of medicinal products on the critical medicines lists
• Article 8 — Reporting and recommendations on shortages of medicinal products
• Article 9 — Working methods and provision of information on medicinal products
• Article 10 — Obligations on marketing authorisation holders
• Article 11 — Role of Member States in the monitoring and mitigation of shortages of medicinal products
• Article 12 — Role of the Commission regarding the monitoring and mitigation of shortages of medicinal products
• Article 13 — European shortages monitoring platform
• Article 14 — Communication regarding the MSSG

Chapter III MEDICINAL PRODUCTS WITH THE POTENTIAL TO ADDRESS PUBLIC HEALTH EMERGENCIES

• Article 15 — Emergency Task Force
• Article 16 — Advice on clinical trials
• Article 17 — Public information regarding clinical trials and marketing authorisation decisions
• Article 18 — Review of medicinal products and recommendations on their use
• Article 19 — Communication regarding the ETF
• Article 20 — IT tools and data

Chapter IV MONITORING AND MITIGATING SHORTAGES OF CRITICAL MEDICAL DEVICES AND SUPPORT FOR EXPERT PANELS

• Article 21 — Executive Steering Group on Shortages of Medical Devices
• Article 22 — List of critical medical devices and information to be provided
• Article 23 — Monitoring shortages of medical devices on the public health emergency critical devices list
• Article 24 — Reporting and recommendations on shortages of medical devices
• Article 25 — Working methods and provision of information on medical devices
• Article 26 — Obligations on manufacturers of medical devices, authorised representatives, importers, distributors and notified bodies
• Article 27 — Role of Member States in the monitoring and mitigation of shortages of medical devices
• Article 28 — Role of the Commission regarding the monitoring and mitigation of shortages of medical devices
• Article 29 — Communication regarding the MDSSG
• Article 30 — Support for the expert panels on medical devices

Chapter V FINAL PROVISIONS

• Article 31 — Cooperation between the MSSG, the MDSSG, the ETF and the expert panels
• Article 32 — Transparency and conflicts of interest
• Article 33 — Protection against cyber attacks
• Article 34 — Confidentiality
• Article 35 — Personal data protection
• Article 36 — Reporting and review
• Article 37 — Union financing
• Article 38 — Entry into Force and date of application