Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rul... (32022R0020)
Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)
- COMMISSION IMPLEMENTING REGULATION (EU) 2022/20
- of 7 January 2022
- laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials
- (Text with EEA relevance)
- CHAPTER I
- GENERAL PROVISIONS
- Article 1
- Subject matter and scope
- Article 2
- Definitions
- CHAPTER II
- COORDINATED SAFETY ASSESSMENT
- Article 3
- Selection of the safety assessing Member State
- Article 4
- Changing the Safety Assessing Member State
- Article 5
- Role and tasks of the safety assessing Member State
- Article 6
- Screening and assessment of suspected unexpected serious adverse reactions
- Article 7
- The assessment of the annual safety reports
- Article 8
- Recommendations of corrective measures and other actions for safety oversight related to the active substance
- Article 9
- The role of the Member States concerned and the reporting Member States in the coordinated safety assessment
- Article 10
- Lead safety assessing Member State
- CHAPTER III
- MISCELLANEOUS PROVISIONS
- Article 11
- Information systems to support the cooperation in safety assessment
- Article 12
- The role of the Clinical Trials Coordination and Advisory Group in coordinated safety assessment
- Article 13
- Union controls
- CHAPTER IV
- FINAL PROVISIONS
- Article 14
- Fees
- Article 15
- Entry into force
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