Commission Implementing Regulation (EU) 2024/3169 of 18 December 2024 laying down... (32024R3169)
INHALT
Commission Implementing Regulation (EU) 2024/3169 of 18 December 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council with regard to the procedures for joint scientific consultations on medicinal products for human use at Union level
- COMMISSION IMPLEMENTING REGULATION (EU) 2024/3169
- of 18 December 2024
- laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council with regard to the procedures for joint scientific consultations on medicinal products for human use at Union level
- (Text with EEA relevance)
- Article 1
- Subject matter
- Article 2
- Setting of request periods for joint scientific consultation
- Article 3
- Submission of requests for joint scientific consultations
- Article 4
- Provision of information to the health technology developer on engagement in joint scientific consultations
- Article 5
- Selection of individual experts for joint scientific consultations
- Article 6
- Professional secrecy obligations of individual experts
- Article 7
- Briefing package and further data for joint scientific consultations
- Article 8
- Establishment of the template of the briefing package where the joint scientific consultation is carried out in parallel with the scientific advice
- Article 9
- List of issues to be discussed in the meeting for an exchange of views
- Article 10
- Input of individual experts on joint scientific consultation
- Article 11
- Consultation of stakeholder organisations during joint scientific consultation
- Article 12
- Meeting with the health technology developer
- Article 13
- Joint scientific consultation outcome document
- Article 14
- Correspondence during joint scientific consultations
- Article 15
- Personal data processing
- Article 16
- Entry into force and date of application
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