Contents
- 1. The health technology developer shall submit the dossier o…
- 2. The deadline to submit the briefing package shall be set i…
- 3. Where the assessor or the co-assessor considers that furth…
- 4. Where the assessor or the co-assessor, at any time during…
- 5. In addition to the rules set out in paragraphs 1 to 4, whe…
1.The health technology developer shall submit the dossier of information, data, analyses and other evidence for joint scientific consultation on medicinal products pursuant to Article 21, point (b), of Regulation (EU) 2021/2282 including the list of questions (‘the briefing package’) by means of the template established by the Coordination Group pursuant to Article 21, point (b), of Regulation (EU) 2021/2282 or pursuant to Article 8 of this Regulation through the HTA IT platform.
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