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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)- Recitals
CHAPTER I — GENERAL PROVISIONS- 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
- SECTION 4 — Voluntary cooperation on health technology assessment
- CHAPTER III — GENERAL RULES FOR JOINT CLINICAL ASSESSMENTS
- CHAPTER IV — SUPPORT FRAMEWORK
- CHAPTER V — FINAL PROVISIONS
- Final
- ANNEX I — Dossier specifications for medicinal products
- ANNEX II — Dossier specifications for medical devices and in vitro diagnostic medical devices