Council of the European Union and European Parliament 15 December 2021, Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance)

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European Union · · · Cited by 135 · 15-12-2021

CHAPTER I. GENERAL PROVISIONS
Article 1. Subject matter
Article 2. Definitions
Article 3. Member State Coordination Group on Health Technology Assessment
Article 4. Quality assurance
Article 5. Transparency and conflict of interest
Article 6. Annual work programme and annual report
CHAPTER II. JOINT WORK ON HEALTH TECHNOLOGY ASSESSMENT AT UNION LEVEL
SECTION 1. Joint clinical assessments
Article 7. Health technologies subject to joint clinical assessments
Article 8. Initiation of joint clinical assessments
Article 9. Joint clinical assessment reports and the dossier of the health technology developer
Article 10. Obligations of health technology developers and consequences of non-compliance
Article 11. Assessment process for joint clinical assessments
Article 12. Finalisation of the joint clinical assessments
Article 13. Member States’ rights and obligations
Article 14. Updates of joint clinical assessments
Article 15. Adoption of detailed procedural rules for joint clinical assessments
SECTION 2. Joint scientific consultations
Article 16. Principles of joint scientific consultations
Article 17. Requests for joint scientific consultations
Article 18. Preparation of the joint scientific consultations outcome document
Article 19. Approval of joint scientific consultation outcome documents
Article 20. Adoption of detailed procedural rules for joint scientific consultations
Article 21. Format and templates of submission and outcome documents for joint scientific consultations
SECTION 3. Emerging health technologies
Article 22. Identification of emerging health technologies
SECTION 4. Voluntary cooperation on health technology assessment
Article 23. Voluntary cooperation
CHAPTER III. GENERAL RULES FOR JOINT CLINICAL ASSESSMENTS
Article 24. National clinical assessment reports
Article 25. General procedural rules
Article 26. Format and templates of submission and report documents
CHAPTER IV. SUPPORT FRAMEWORK
Article 27. Union financing
Article 28. Commission support for the Coordination Group
Article 29. Stakeholder network
Article 30. IT platform
Article 31. Evaluation and reporting
CHAPTER V. FINAL PROVISIONS
Article 32. Exercise of the delegation
Article 33. Committee procedure
Article 34. Preparation of implementing acts
Article 35. Amendment to Directive 2011/24/EU
Article 36. Entry into force and date of application
ANNEX I. Dossier specifications for medicinal products

22.12.2021

Official Journal of the European Union

L 458/1

REGULATION (EU) 2021/2282 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 15 December 2021

on health technology assessment and amending Directive 2011/24/EU

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

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