Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January…

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)

regulation · European Union · 32022R0123

324 provisions in 775 nodes · cited by 1 instruments we hold · 16 provisions hand work to national law

Defined terms · All instruments · Internet · artificial intelligence · biodiversity · competition · competition law · computer science · confidentiality · consumer

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

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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

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Article 6 Lists of critical medicinal products and information to be provided

Article 7 Monitoring shortages of medicinal products on the critical medicines lists

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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

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

Article 15 Emergency Task Force

Article 16 Advice on clinical trials

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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

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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

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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

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Article 24 Reporting and recommendations on shortages of medical devices

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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

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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

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Article 32 Transparency and conflicts of interest

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Article 33 Protection against cyber attacks

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Article 34 Confidentiality

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Article 35 Personal data protection

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Article 36 Reporting and review

Article 37 Union financing

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Article 38 Entry into Force and date of application

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Preamble