European Commission 7 January 2022, 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)

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European Union · · · 07-01-2022

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

10.1.2022

Official Journal of the European Union

L 5/14

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

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