Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 Dec... (32021R2282)
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)
- 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)
- 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
- ANNEX II
- Dossier specifications for medical devices and
- in vitro
- diagnostic medical devices
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