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Document C(2024)1627
D1-239795 CIS on the Variation Regulation
KOMISIJOS DELEGUOTASIS REGLAMENTAS (ES) …/... kuriuo dėl žmonėms skirtų vaistų rinkodaros leidimų sąlygų keitimo nagrinėjimo iš dalies keičiamas Komisijos reglamentas (EB) 1234/2008
- Initiative summary:
- This initiative, announced in the Pharmaceutical Strategy for Europe, aims to review the current rules setting out the procedures for post-authorisation changes to a marketing authorisation for medicines for human use. The purpose is to make the lifecycle management of medicines more efficient.
- EuroVoc thesaurus:
- sveikatos politika; vaistinių preparatų kontrolė ir priežiūra; vaistinis preparatas; pritarimas prekybai; rinkodaros standartas
- See the lifecycle of this act on the Interinstitutional register of delegated acts
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- Documents:
- Ares(2023)5859980 (Call for evidence for an initiative)Ares(2023)5859980 (Call for evidence for an initiative)
- Leading service:
- Directorate-General for Health and Food Safety
- Expert group:
- Pharmaceutical Committee
- Planned adoption period:
- 01/01/2024 - 31/03/2024
- 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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- Documents:
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C/2024/1627 final (Delegated regulation)
Staff working document - Leading service:
- Directorate-General for Health and Food Safety
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- Foreseen end of objection period:
- 11/06/2024
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- Documents:
- 32024R1701 (Delegated regulation)