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Document 52023PC0193
Evaluation and revision of the EU pharmaceutical legislation - Regulation
Forslag til EUROPA-PARLAMENTETS OG RÅDETS FORORDNING om fastlæggelse af EU-procedurer for godkendelse og overvågning af humanmedicinske lægemidler og om fastsættelse af regler for Det Europæiske Lægemiddelagentur, om ændring af forordning (EF) nr. 1394/2007 og (EU) nr. 536/2014 og om ophævelse af forordning (EF) nr. 726/2004, (EF) nr. 141/2000 og (EF) nr. 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:
- sundhedspolitik; Det Europæiske Lægemiddelagentur; lægemiddel; institutionernes funktion; salgstilladelse; forbrugeroplysning; etikettering; forsyningssikkerhed; offentlig sundhed; lovgivning om apotekervæsen; handelsnorm
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- Documents:
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Ares(2021)2390324 (Inception impact assessment)Ares(2021)2390324 (Inception impact assessment)
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) - 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
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
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- Documents:
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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