Laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795

votedEuropean Union· European Parliament· EN

Introduced

21 May 2025

Last action

14 July 2026 · committee approve provisional agreement

Status

PLENARY_VOTE

Official titles

Authentic titles published by the source. The stored canonical title is not replaced.

23 official languages

Bulgarian
Определяне на рамка за укрепване на наличността и сигурността на доставките на критично важни лекарствени продукти, както и на наличността и достъпността на лекарствени продукти от общ интерес и изменение на Регламент (ЕС) 2024/795
Czech
Stanovení rámce pro posílení dostupnosti a bezpečnosti dodávek kriticky důležitých léčivých přípravků, jakož i dostupnosti a přístupnosti léčivých přípravků obecného zájmu, a změna nařízení (EU) 2024/795
Danish
Fastlæggelse af rammer, der skal styrke tilgængeligheden af og forsyningssikkerheden for kritiske lægemidler samt tilgængeligheden af og adgangen til lægemidler af fælles interesse, og om ændring af forordning (EU) 2024/795
German
Schaffung eines Rahmens für die Stärkung der Verfügbarkeit von und der Sicherheit der Versorgung mit kritischen Arzneimitteln sowie der Verfügbarkeit und der Zugänglichkeit von Arzneimitteln von gemeinsamem Interesse und Änderung der Verordnung (EU) 2024/795
Greek
Θέσπιση πλαισίου για την ενίσχυση της διαθεσιμότητας και της ασφάλειας του εφοδιασμού με φάρμακα κρίσιμης σημασίας, καθώς και της διαθεσιμότητας φαρμάκων κοινού ενδιαφέροντος και της πρόσβασης σε αυτά, και τροποποίηση του κανονισμού (EΕ) 2024/795
Spanish
Establecimiento de un marco para reforzar la disponibilidad y la seguridad del suministro de medicamentos esenciales, así como la disponibilidad y accesibilidad de los medicamentos de interés común, y modificación del Reglamento (UE) 2024/795
Estonian
Raamistiku kehtestamine selleks, et parandada esmatähtsate ravimite kättesaadavust ja tarnekindlust ning ühist huvi pakkuvate ravimite kättesaadavust ja juurdepääsetavust, ning määruse (EL) 2024/795 muutmine
Finnish
Kriittisten lääkkeiden saatavuuden ja toimitusvarmuuden sekä yleisen edun kannalta tärkeiden lääkkeiden saatavuuden ja saavutettavuuden parantamista koskevat puitteet sekä asetuksen (EU) 2024/795 muuttaminen
French
Établissement d’un cadre visant à renforcer la disponibilité et la sécurité de l’approvisionnement en médicaments critiques ainsi que la disponibilité et l’accessibilité des médicaments d’intérêt commun, et modification du règlement (UE) 2024/795
Irish
Creat a leagan síos chun infhaighteacht agus slándáil soláthair táirgí íocshláinte criticiúla, chomh maith le hinfhaighteacht agus inrochtaineacht táirgí íocshláinte leasa choitinn, a neartú, agus Rialachán (AE) 2024/795 a leasú
Croatian
Utvrđivanje okvira za jačanje dostupnosti i sigurnosti opskrbe kritičnim lijekovima i dostupnosti i pristupačnosti lijekova od zajedničkog interesa te izmjena Uredbe (EU) 2024/795
Hungarian
A kritikus fontosságú gyógyszerek rendelkezésre állásának, az ilyen gyógyszerekkel való ellátás biztonságának, valamint a közös érdekű gyógyszerek rendelkezésre állásának és hozzáférhetőségének megerősítését célzó keret létrehozása, továbbá az (EU) 2024/795 rendelet módosítása
Italian
Istituzione di un quadro volto a rafforzare la disponibilità e la sicurezza dell'approvvigionamento di medicinali critici, nonché la disponibilità e l'accessibilità dei medicinali di interesse comune, e modifica del regolamento (UE) 2024/795
Lithuanian
Ypatingos svarbos vaistų prieinamumo ir tiekimo saugumo stiprinimo, taip pat bendro intereso vaistų prieinamumo bei galimybių jų gauti gerinimo sistemos nustatymas ir Reglamento (ES) 2024/795 dalinis keitimas
Latvian
Regulējuma noteikšana kritiski svarīgu zāļu pieejamības un piegādes drošības stiprināšanai un kopīgi interesējošu zāļu pieejamības un piekļūstamības uzlabošanai un Regulas (ES) 2024/795 grozīšana
Maltese
L-istabbiliment ta’ qafas għat-tisħiħ tad-disponibbiltà u s-sigurtà tal-provvista ta’ prodotti mediċinali kritiċi kif ukoll id-disponibbiltà ta’ prodotti mediċinali ta’ interess komuni u l-aċċessibbiltà tagħhom, u l-emenda tar-Regolament (UE) 2024/795
Dutch
Vaststelling van een kader voor de vergroting van de beschikbaarheid en voorzieningszekerheid van kritieke geneesmiddelen, en van de beschikbaarheid en toegankelijkheid van geneesmiddelen van gemeenschappelijk belang, en wijziging van Verordening (EU) 2024/795
Polish
Ustanowienie ram na potrzeby zwiększenia dostępności i bezpieczeństwa dostaw produktów leczniczych o krytycznym znaczeniu, a także dostępności produktów leczniczych będących przedmiotem wspólnego zainteresowania i dostępu do tych produktów, oraz zmiana rozporządzenia (UE) 2024/795
Portuguese
Estabelecimento de um quadro para reforçar a disponibilidade e a segurança do abastecimento de medicamentos críticos, bem como a disponibilidade e a acessibilidade dos medicamentos de interesse comum, e alteração do Regulamento (UE) 2024/795
Romanian
Stabilirea unui cadru pentru consolidarea disponibilității și a securității aprovizionării cu medicamente critice, precum și a disponibilității și accesibilității medicamentelor de interes comun și modificarea Regulamentului (UE) 2024/795
Slovak
Stanovenie rámca na posilnenie dostupnosti a bezpečnosti dodávok kritických liekov, ako aj dostupnosti a prístupnosti liekov spoločného záujmu, a zmena nariadenia (EÚ) 2024/795
Slovenian
Določitev okvira za povečanje razpoložljivosti kritičnih zdravil in zanesljivosti preskrbe z njimi ter razpoložljivosti in dostopnosti zdravil v skupnem interesu ter sprememba Uredbe (EU) 2024/795
Swedish
Inrättande av en ram för att stärka tillgången till och försörjningstryggheten för kritiska läkemedel samt tillgången och tillgängligheten till läkemedel av gemensamt intresse, och ändring av förordning (EU) 2024/795

Records

Official bill 2025/0102(COD) from European Union at European Parliament. Dated 21 May 2025. Status: PLENARY_VOTE.

Timeline

21 May 2025
referral
Source: REFERRAL
21 May 2025
Introduced
Laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795
Source: COD
18 July 2025
committee tabling report
Source: COMMITTEE_TABLING_REPORT
26 September 2025
committee tabling amendment
Source: COMMITTEE_TABLING_AMENDMENT
13 October 2025
committee tabling amendment
Source: COMMITTEE_TABLING_AMENDMENT
13 October 2025
committee tabling amendment
Source: COMMITTEE_TABLING_AMENDMENT
4 November 2025
committee adopting opinion
Source: COMMITTEE_ADOPTING_OPINION
11 November 2025
committee adopting opinion
Source: COMMITTEE_ADOPTING_OPINION
11 November 2025
committee adopting opinion
Source: COMMITTEE_ADOPTING_OPINION
15 December 2025
committee adopting report
Source: COMMITTEE_ADOPTING_REPORT
19 December 2025
tabling plenary
Source: TABLING_PLENARY
13 January 2026
tabling plenary
Source: TABLING_PLENARY
13 January 2026
tabling plenary
Source: TABLING_PLENARY
14 January 2026
tabling plenary
Source: TABLING_PLENARY
14 January 2026
tabling plenary
Source: TABLING_PLENARY
14 January 2026
tabling plenary
Source: TABLING_PLENARY
19 January 2026
tabling plenary
Source: TABLING_PLENARY
19 January 2026
Plenary debate
Source: PLENARY_DEBATE
19 January 2026
Plenary debate
Source: PLENARY_DEBATE
20 January 2026
plenary amend
Source: PLENARY_AMEND
20 January 2026
Referred for interinstitutional negotiations
Source: PLENARY_REFER_COMMITTEE_INTERINSTITUTIONAL_NEGOTIATIONS
20 January 2026
Plenary vote
Source: PLENARY_VOTE
20 January 2026
Vote results
Source: PLENARY_VOTE_RESULTS
20 January 2026
Plenary vote
Source: PLENARY_VOTE
2 February 2026
interinstitutional negotiation
Source: INTERINSTITUTIONAL_NEGOTIATION
16 March 2026
interinstitutional negotiation
Source: INTERINSTITUTIONAL_NEGOTIATION
11 May 2026
interinstitutional negotiation
Source: INTERINSTITUTIONAL_NEGOTIATION
14 July 2026
committee approve provisional agreement
Source: COMMITTEE_APPROVE_PROVISIONAL_AGREEMENT

Votes

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Documents

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Ram för att stärka tillgången till och försörjningstryggheten för kritiska läkemedel samt tillgången och tillgängligheten till läkemedel av gemensamt intresse

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Ram för att stärka tillgången till och försörjningstryggheten för kritiska läkemedel samt tillgången och tillgängligheten till läkemedel av gemensamt intresse
TEXT_ADOPTED · SV · 7 May 2026
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Regulējuma noteikšana kritiski svarīgu zāļu pieejamības un piegādes drošības stiprināšanai un kopīgi interesējošu zāļu pieejamības un piekļūstamības uzlabošanai
TEXT_ADOPTED · LV · 7 May 2026
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Kader voor de vergroting van de beschikbaarheid en voorzieningszekerheid van kritieke geneesmiddelen, en van de beschikbaarheid en toegankelijkheid van geneesmiddelen van gemeenschappelijk belang
TEXT_ADOPTED · NL · 7 May 2026
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Ramy na potrzeby zwiększenia dostępności i bezpieczeństwa dostaw produktów leczniczych o krytycznym znaczeniu, a także dostępności produktów leczniczych będących przedmiotem wspólnego zainteresowania i dostępu do tych produktów
TEXT_ADOPTED · PL · 7 May 2026
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Un cadru pentru consolidarea disponibilității și a securității aprovizionării cu medicamente critice, precum și a disponibilității și accesibilității medicamentelor de interes comun
TEXT_ADOPTED · RO · 7 May 2026
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Quadro para reforçar a disponibilidade e a segurança do abastecimento de medicamentos críticos, bem como a disponibilidade e a acessibilidade de produtos médicos de interesse comum
TEXT_ADOPTED · PT · 7 May 2026
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Okvir za povečanje razpoložljivosti kritičnih zdravil in zanesljivosti preskrbe z njimi ter razpoložljivosti in dostopnosti zdravil v skupnem interesu
TEXT_ADOPTED · SL · 7 May 2026
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Ypatingos svarbos vaistų prieinamumo ir tiekimo saugumo stiprinimo, taip pat bendro intereso vaistų prieinamumo bei galimybių jų gauti gerinimo sistema
TEXT_ADOPTED · LT · 7 May 2026
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Qafas għat-tisħiħ tad-disponibbiltà u s-sigurtà tal-provvista ta’ prodotti mediċinali kritiċi kif ukoll id-disponibbiltà ta’ prodotti mediċinali ta’ interess komuni u l-aċċessibbiltà tagħhom
TEXT_ADOPTED · MT · 7 May 2026
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Rámec na posilnenie dostupnosti a bezpečnosti dodávok kritických liekov, ako aj dostupnosti a prístupnosti liekov spoločného záujmu
TEXT_ADOPTED · SK · 7 May 2026
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Kriittisten lääkkeiden saatavuuden ja toimitusvarmuuden sekä yleisen edun kannalta tärkeiden lääkkeiden saatavuuden ja saavutettavuuden parantamista koskevat puitteet
TEXT_ADOPTED · FI · 7 May 2026
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Cadre visant à renforcer la disponibilité et la sécurité de l’approvisionnement en médicaments critiques ainsi que la disponibilité et l’accessibilité des médicaments d’intérêt commun
TEXT_ADOPTED · FR · 7 May 2026
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Raamistik esmatähtsate ravimite kättesaadavuse ja tarnekindluse ning ühist huvi pakkuvate ravimite kättesaadavuse ja juurdepääsetavuse parandamiseks
TEXT_ADOPTED · ET · 7 May 2026
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Quadro volto a rafforzare la disponibilità e la sicurezza dell'approvvigionamento di medicinali critici, nonché la disponibilità e l'accessibilità dei medicinali di interesse comune
TEXT_ADOPTED · IT · 7 May 2026
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Okvir za jačanje dostupnosti i sigurnosti opskrbe kritičnim lijekovima i dostupnosti i pristupačnosti lijekova od zajedničkog interesa
TEXT_ADOPTED · HR · 7 May 2026
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Θέσπιση πλαισίου για την ενίσχυση της διαθεσιμότητας και της ασφάλειας του εφοδιασμού με φάρμακα κρίσιμης σημασίας, καθώς και της διαθεσιμότητας και της προσβασιμότητας φαρμάκων κοινού ενδιαφέροντος
TEXT_ADOPTED · EL · 7 May 2026
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Marco para reforzar la disponibilidad y la seguridad del suministro de medicamentos esenciales, así como la disponibilidad y accesibilidad de los medicamentos de interés común
TEXT_ADOPTED · ES · 7 May 2026
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A kritikus fontosságú gyógyszerek rendelkezésre állásának, az ilyen gyógyszerekkel való ellátás biztonságának, valamint a közös érdekű gyógyszerek rendelkezésre állásának és hozzáférhetőségének megerősítését célzó keret létrehozása
TEXT_ADOPTED · HU · 7 May 2026
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Creat a leagan síos chun infhaighteacht agus slándáil soláthair táirgí íocshláinte criticiúla, chomh maith le hinfhaighteacht agus inrochtaineacht táirgí íocshláinte leasa choitinn, a neartú
TEXT_ADOPTED · GA · 7 May 2026
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Framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest
TEXT_ADOPTED · EN · 7 May 2026
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Рамка за укрепване на наличността и сигурността на доставките на критично важни лекарствени продукти, както и на наличността и достъпността на лекарствени продукти от общ интерес
TEXT_ADOPTED · BG · 7 May 2026
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Rahmen für die Stärkung der Verfügbarkeit von und der Sicherheit der Versorgung mit kritischen Arzneimitteln sowie der Verfügbarkeit und der Zugänglichkeit von Arzneimitteln von gemeinsamem Interesse
TEXT_ADOPTED · DE · 7 May 2026
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Rammer, der skal styrke tilgængeligheden af og forsyningssikkerheden for kritiske lægemidler samt tilgængeligheden af og adgangen til lægemidler af fælles interesse
TEXT_ADOPTED · DA · 7 May 2026
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Rámec pro posílení dostupnosti a bezpečnosti dodávek kriticky důležitých léčivých přípravků, jakož i dostupnosti a přístupnosti léčivých přípravků společného zájmu
TEXT_ADOPTED · CS · 7 May 2026
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Creat a leagan síos chun infhaighteacht agus slándáil soláthair táirgí íocshláinte criticiúla, chomh maith le hinfhaighteacht agus inrochtaineacht táirgí íocshláinte leasa choitinn, a neartú
TEXT_ADOPTED · GA · 24 April 2026
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Creat a leagan síos chun infhaighteacht agus slándáil soláthair táirgí íocshláinte criticiúla, chomh maith le hinfhaighteacht agus inrochtaineacht táirgí íocshláinte leasa choitinn, a neartú
TEXT_ADOPTED · GA · 24 April 2026
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Ramy na potrzeby zwiększenia dostępności i bezpieczeństwa dostaw produktów leczniczych o krytycznym znaczeniu, a także dostępności produktów leczniczych będących przedmiotem wspólnego zainteresowania i dostępu do tych produktów
TEXT_ADOPTED · PL · 21 April 2026
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Ramy na potrzeby zwiększenia dostępności i bezpieczeństwa dostaw produktów leczniczych o krytycznym znaczeniu, a także dostępności produktów leczniczych będących przedmiotem wspólnego zainteresowania i dostępu do tych produktów
TEXT_ADOPTED · PL · 21 April 2026
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Quadro para reforçar a disponibilidade e a segurança do abastecimento de medicamentos críticos, bem como a disponibilidade e a acessibilidade de produtos médicos de interesse comum
TEXT_ADOPTED · PT · 20 April 2026
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Quadro para reforçar a disponibilidade e a segurança do abastecimento de medicamentos críticos, bem como a disponibilidade e a acessibilidade de produtos médicos de interesse comum
TEXT_ADOPTED · PT · 20 April 2026
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Un cadru pentru consolidarea disponibilității și a securității aprovizionării cu medicamente critice, precum și a disponibilității și accesibilității medicamentelor de interes comun
TEXT_ADOPTED · RO · 17 April 2026
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Un cadru pentru consolidarea disponibilității și a securității aprovizionării cu medicamente critice, precum și a disponibilității și accesibilității medicamentelor de interes comun
TEXT_ADOPTED · RO · 17 April 2026
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Ram för att stärka tillgången till och försörjningstryggheten för kritiska läkemedel samt tillgången och tillgängligheten till läkemedel av gemensamt intresse
TEXT_ADOPTED · SV · 17 April 2026
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Ram för att stärka tillgången till och försörjningstryggheten för kritiska läkemedel samt tillgången och tillgängligheten till läkemedel av gemensamt intresse
TEXT_ADOPTED · SV · 17 April 2026
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Qafas għat-tisħiħ tad-disponibbiltà u s-sigurtà tal-provvista ta’ prodotti mediċinali kritiċi kif ukoll id-disponibbiltà ta’ prodotti mediċinali ta’ interess komuni u l-aċċessibbiltà tagħhom
TEXT_ADOPTED · MT · 16 April 2026
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Qafas għat-tisħiħ tad-disponibbiltà u s-sigurtà tal-provvista ta’ prodotti mediċinali kritiċi kif ukoll id-disponibbiltà ta’ prodotti mediċinali ta’ interess komuni u l-aċċessibbiltà tagħhom
TEXT_ADOPTED · MT · 16 April 2026
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Regulējuma noteikšana kritiski svarīgu zāļu pieejamības un piegādes drošības stiprināšanai un kopīgi interesējošu zāļu pieejamības un piekļūstamības uzlabošanai
TEXT_ADOPTED · LV · 16 April 2026
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Quadro volto a rafforzare la disponibilità e la sicurezza dell'approvvigionamento di medicinali critici, nonché la disponibilità e l'accessibilità dei medicinali di interesse comune
TEXT_ADOPTED · IT · 16 April 2026
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Okvir za jačanje dostupnosti i sigurnosti opskrbe kritičnim lijekovima i dostupnosti i pristupačnosti lijekova od zajedničkog interesa
TEXT_ADOPTED · HR · 16 April 2026
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Cadre visant à renforcer la disponibilité et la sécurité de l’approvisionnement en médicaments critiques ainsi que la disponibilité et l’accessibilité des médicaments d’intérêt commun
TEXT_ADOPTED · FR · 16 April 2026
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Kriittisten lääkkeiden saatavuuden ja toimitusvarmuuden sekä yleisen edun kannalta tärkeiden lääkkeiden saatavuuden ja saavutettavuuden parantamista koskevat puitteet
TEXT_ADOPTED · FI · 16 April 2026
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Kriittisten lääkkeiden saatavuuden ja toimitusvarmuuden sekä yleisen edun kannalta tärkeiden lääkkeiden saatavuuden ja saavutettavuuden parantamista koskevat puitteet
TEXT_ADOPTED · FI · 16 April 2026
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Ypatingos svarbos vaistų prieinamumo ir tiekimo saugumo stiprinimo, taip pat bendro intereso vaistų prieinamumo bei galimybių jų gauti gerinimo sistema
TEXT_ADOPTED · LT · 16 April 2026
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Ypatingos svarbos vaistų prieinamumo ir tiekimo saugumo stiprinimo, taip pat bendro intereso vaistų prieinamumo bei galimybių jų gauti gerinimo sistema
TEXT_ADOPTED · LT · 16 April 2026
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Marco para reforzar la disponibilidad y la seguridad del suministro de medicamentos esenciales, así como la disponibilidad y accesibilidad de los medicamentos de interés común
TEXT_ADOPTED · ES · 16 April 2026
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Framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest
TEXT_ADOPTED · EN · 16 April 2026
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Marco para reforzar la disponibilidad y la seguridad del suministro de medicamentos esenciales, así como la disponibilidad y accesibilidad de los medicamentos de interés común
TEXT_ADOPTED · ES · 16 April 2026
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Framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest
TEXT_ADOPTED · EN · 16 April 2026
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Rámec pro posílení dostupnosti a bezpečnosti dodávek kriticky důležitých léčivých přípravků, jakož i dostupnosti a přístupnosti léčivých přípravků společného zájmu
TEXT_ADOPTED · CS · 16 April 2026
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Rámec pro posílení dostupnosti a bezpečnosti dodávek kriticky důležitých léčivých přípravků, jakož i dostupnosti a přístupnosti léčivých přípravků společného zájmu
TEXT_ADOPTED · CS · 16 April 2026
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Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2025%2F0102(COD)
Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2025-0102
eu · 2025-0102 · source updated 14 July 2026