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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
(Text with EEA relevance)- Recitals
CHAPTER I — GENERAL PROVISIONS- 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
- Final