Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 Janu... (32022R0123)
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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)
- 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)
- 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
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