Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 laying down, pur... (32024R1381)
Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments
- COMMISSION IMPLEMENTING REGULATION (EU) 2024/1381
- of 23 May 2024
- laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments
- (Text with EEA relevance)
- Article 1
- Subject matter
- Article 2
- Relevant information for the development of the assessment scope
- Article 3
- Exchange of information with the European Medicines Agency
- Article 4
- Information to the Coordination Group
- Article 5
- Information to the health technology developer about the start of a joint clinical assessment
- Article 6
- Selection of patients, clinical experts and other relevant experts
- Article 7
- Professional secrecy obligations of patients, clinical experts and other relevant experts
- Article 8
- Consultation of stakeholder organisations during joint clinical assessments
- Article 9
- Assessment scope proposal
- Article 10
- Finalisation of the assessment scope
- Article 11
- Assessment scope explanation meeting
- Article 12
- Dossier and further data for joint clinical assessment provided by the health technology developer
- Article 13
- Commission’s confirmation of the dossier for a joint clinical assessment
- Article 14
- Draft joint clinical assessment and summary reports
- Article 15
- Finalisation of the revised draft joint clinical assessment and summary reports
- Article 16
- Changes to the therapeutic indication(s)
- Article 17
- Re-initiation of joint clinical assessments
- Article 18
- Updates of joint clinical assessments
- Article 19
- Correspondence during joint clinical assessments
- Article 20
- Confidentiality requests
- Article 21
- Personal data processing
- Article 22
- Entry into force and date of application
- ANNEX I
- TEMPLATE FOR THE DOSSIER OF THE JOINT CLINICAL ASSESSMENT OF A MEDICINAL PRODUCT
- Revision history
- List of abbreviations
- Table of contents
- List of tables
- 1. Overview
- 2. Background
- 3. Assessment scope
- 4. Description of methods used in the development of the content of the dossier
- 5. Results
- 6. List of references
- Appendixes
- ANNEX II
- TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT REPORT
- List of abbreviations
- Table of contents
- List of tables
- 1. General information on the JCA
- 2. Background
- 3. Assessment scope
- 4. Results
- 5. References
- Appendixes
- ANNEX III
- TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT SUMMARY REPORT
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