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Health Technology Assessment Regulation

Regulation (EU) 2021/2282 on health technology assessment
32021R2282 · official text on EUR-Lex

Articles

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