This document is an excerpt from the EUR-Lex website
Document 52023SC0192
- 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:
- health policy; labelling; pharmaceutical legislation; Malta; Northern Ireland; Ireland; public health; Cyprus; market approval; medicinal product; marketing standard; consumer information; security of supply; European Medicines Agency
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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:
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COM/2023/192 final (Proposal for a directive)
SWD/2023/192 final (Impact assessment)
SWD/2023/193 final (Summary of impact assessment)
SWD/2023/191 final (Staff working document) - Leading service:
- Directorate-General for Health and Food Safety
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- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 8