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Document 52023PC0193
Evaluation and revision of the EU pharmaceutical legislation - Regulation
Propuesta de REGLAMENTO DEL PARLAMENTO EUROPEO Y DEL CONSEJO por el que se establecen los procedimientos de la Unión para la autorización y el control de los medicamentos de uso humano, se establecen las normas por las que se rige la Agencia Europea de Medicamentos, se modifican el Reglamento (CE) n.º 1394/2007 y el Reglamento (UE) n.º 536/2014 y se derogan el Reglamento (CE) n.º 726/2004, el Reglamento (CE) n.º 141/2000 y el Reglamento (CE) n.º 1901/2006
- Initiative summary:
- The revision of the general pharmaceutical legal framework, aims to ensure access to affordable medicines in the EU. It aims to foster innovation including in areas of unmet medical need (such as in antimicrobials) and to enhance security of supply while adapting to new scientific and technological developments and reducing regulatory burden where possible. Drawing lessons from the COVID-19 pandemic, it will support a future-proof and crisis-resistant pharmaceuticals system.
- EuroVoc thesaurus:
- política sanitaria; Agencia Europea de Medicamentos; medicamento; funcionamiento institucional; autorización de venta; información al consumidor; etiquetado; seguridad de abastecimiento; salud pública; legislación farmacéutica; norma de comercialización
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- Documents:
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Ares(2021)2185074 (Inception impact assessment)Ares(2021)2185074 (Inception impact assessment)
Ares(2022)977395 (Factual summary report of the public consultation)Ares(2022)977395 (Factual summary report of the public consultation)
Ares(2021)2390324 (Inception impact assessment)Ares(2021)2390324 (Inception impact assessment) - Leading service:
- Directorate-General for Health and Food Safety
- Planned adoption period:
- 01/10/2022 - 31/12/2022
- Check the status of this initiative on the Better Regulation Portal
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- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
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- Consultation type:
- Public consultation
- Consultation duration (weeks):
- 12
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- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
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- Documents:
-
COM/2023/193 final (Proposal for a regulation)
Staff working document - Leading service:
- Directorate-General for Health and Food Safety
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- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 8