European Union · Bill · COD
2022/0216(COD)
Standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
Introduced
12 September 2022
Last action
17 July 2024 · publication official journal
Status
PLENARY_VOTE
Sponsors
—
Subjects
Discovery layer
Source updated
17 July 2024
Official titles
Authentic titles published by the source. The stored canonical title is not replaced.
23 official languages
Bulgarian
Стандарти за качество и безопасност на субстанциите от човешки произход, предназначени за приложение при човека, и за отмяна на Директива 2002/98/ЕО и Директива 2004/23/ЕО
Czech
Standardy jakosti a bezpečnosti látek lidského původu určených k použití u člověka a o zrušení směrnic 2002/98/ES a 2004/23/ES
Danish
Kvalitets- og sikkerhedsstandarder for substanser af menneskelig oprindelse bestemt til anvendelse i mennesker og om ophævelse af direktiv 2002/98/EF og 2004/23/EF
German
Qualitäts- und Sicherheitsstandards für zur Verwendung beim Menschen bestimmte Substanzen menschlichen Ursprungs und Aufhebung der Richtlinien 2002/98/EG und 2004/23/EG
Greek
Πρότυπα ποιότητας και ασφάλειας για τις ουσίες ανθρώπινης προέλευσης που προορίζονται για χρήση στον άνθρωπο και κατάργηση των οδηγιών 2002/98/ΕΚ και 2004/23/ΕΚ
Spanish
Normas de calidad y seguridad de las sustancias de origen humano destinadas a su aplicación en el ser humano y derogación de las Directivas 2002/98/CE y 2004/23/CE
Estonian
Inimkasutuseks ettenähtud inimpäritolu materjali kvaliteedi- ja ohutusnõuded ning direktiivide 2002/98/EÜ ja 2004/23/EÜ kehtetuks tunnistamine
Finnish
Ihmisessä käytettäväksi tarkoitettujen ihmisperäisten aineiden laatu- ja turvallisuusvaatimukset ja direktiivien 2002/98/EY ja 2004/23/EY kumoaminen
French
Normes de qualité et de sécurité des substances d’origine humaine destinées à une application humaine et abrogeant les directives 2002/98/CE et 2004/23/CE
Irish
Caighdeáin cháilíochta agus sábháilteachta le haghaidh substaintí de bhunús daonna a bheartaítear lena n-úsáid sa duine agus lena n-aisghairtear Treoir 2002/98/CE agus Treoir 2004/23/CE
Croatian
Standardi kvalitete i sigurnosti za tvari ljudskog podrijetla namijenjene primjeni kod ljudi i stavljanje izvan snage direktiva 2002/98/EZ i 2004/23/EZ
Hungarian
Az emberi felhasználásra szánt emberi eredetű anyagokra vonatkozó minőségi és biztonsági előírások, valamint a 2002/98/EK és a 2004/23/EK irányelv hatályon kívül helyezése
Italian
Parametri di qualità e sicurezza per le sostanze di origine umana destinate all'applicazione sugli esseri umani e abrogazione delle direttive 2002/98/CE e 2004/23/CE
Lithuanian
Iš žmogaus gautų medžiagų, skirtų naudoti žmogui, kokybės ir saugos standartai ir direktyvų 2002/98/EB ir 2004/23/EB panaikinimas
Latvian
Kvalitātes un drošības standarti cilvēku izcelsmes vielām, kuras paredzēts izmantot cilvēkiem, un Direktīvas 2002/98/EK un Direktīvas 2004/23/EK atcelšana
Maltese
Standards ta’ kwalità u ta’ sikurezza għas-sustanzi ta’ oriġini umana maħsubin għall-applikazzjoni umana u tħassir tad-Direttivi 2002/98/KE u 2004/23/KE
Dutch
Kwaliteits- en veiligheidsnormen voor stoffen van menselijke oorsprong die bestemd zijn voor toepassing op de mens en intrekking van Richtlijn 2002/98/EG en Richtlijn 2004/23/EG
Polish
Normy jakości i bezpieczeństwa substancji pochodzenia ludzkiego przeznaczonych do zastosowania u ludzi oraz uchylenie dyrektyw 2002/98/WE i 2004/23/WE
Portuguese
Normas de qualidade e segurança para as substâncias de origem humana destinadas à aplicação em seres humanos e revogação das Diretivas 2002/98/CE e 2004/23/CE
Romanian
Standarde de calitate și siguranță pentru substanțele de origine umană destinate utilizării la om și abrogarea Directivelor 2002/98/CE și 2004/23/CE
Slovak
Normy kvality a bezpečnosti pre látky ľudského pôvodu určené na humánne použitie a zrušenie smerníc 2002/98/ES a 2004/23/ES
Slovenian
Standardi kakovosti in varnosti za snovi človeškega izvora, namenjene za uporabo na ljudeh, ter razveljavitev direktiv 2002/98/ES in 2004/23/ES
Swedish
Kvalitets- och säkerhetsstandarder för ämnen av mänskligt ursprung avsedda för användning på människor och upphävande av direktiven 2002/98/EG och 2004/23/EG
Records
Official bill 2022/0216(COD) from European Union at European Parliament. Dated 12 September 2022. Status: PLENARY_VOTE.
Timeline
12 September 2022
referral
Source: REFERRAL
12 September 2022
Introduced
Standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
Source: COD
18 January 2023
committee tabling report
Source: COMMITTEE_TABLING_REPORT
18 July 2023
committee adopting report
Source: COMMITTEE_ADOPTING_REPORT
26 July 2023
tabling plenary
Source: TABLING_PLENARY
12 September 2023
Plenary vote
Source: PLENARY_VOTE
12 September 2023
Vote results
Source: PLENARY_VOTE_RESULTS
12 September 2023
plenary amend
Source: PLENARY_AMEND
12 September 2023
Referred for interinstitutional negotiations
Source: PLENARY_REFER_COMMITTEE_INTERINSTITUTIONAL_NEGOTIATIONS
12 September 2023
Plenary vote
Source: PLENARY_VOTE
14 February 2024
committee approve provisional agreement
Source: COMMITTEE_APPROVE_PROVISIONAL_AGREEMENT
24 April 2024
Vote results
Source: PLENARY_VOTE_RESULTS
24 April 2024
Plenary vote
Source: PLENARY_VOTE
24 April 2024
plenary amend proposal
Source: PLENARY_AMEND_PROPOSAL
24 April 2024
Plenary vote
Source: PLENARY_VOTE
13 June 2024
signature
Source: SIGNATURE
17 July 2024
publication official journal
Source: PUBLICATION_OFFICIAL_JOURNAL
Votes
No vote records are attached yet.
Versions
No version snapshots stored. Document URLs remain at the source.
Documents
221 official files
Standards of quality and safety for substances of human origin intended for human application
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Standards of quality and safety for substances of human origin intended for human application
TEXT_ADOPTED · EN · 29 October 2025
Standards of quality and safety for substances of human origin intended for human application
TEXT_ADOPTED · EN · 29 October 2025
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Normy kvality a bezpečnosti pre látky ľudského pôvodu určené na humánne použitie
TEXT_ADOPTED · SK · 8 October 2024
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Parametri di qualità e sicurezza per le sostanze di origine umana destinate all'applicazione sugli esseri umani
TEXT_ADOPTED · IT · 8 October 2024
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Стандарти за качество и безопасност на субстанциите от човешки произход, предназначени за приложение при човека
TEXT_ADOPTED · BG · 8 October 2024
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Standarde de calitate și siguranță pentru substanțele de origine umană destinate utilizării la om
TEXT_ADOPTED · RO · 8 October 2024
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Iš žmogaus gautų medžiagų, skirtų naudoti žmogui, kokybės ir saugos standartai
TEXT_ADOPTED · LT · 8 October 2024
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Πρότυπα ποιότητας και ασφάλειας για τις ουσίες ανθρώπινης προέλευσης που προορίζονται για χρήση στον άνθρωπο
TEXT_ADOPTED · EL · 8 October 2024
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Standards ta’ kwalità u ta’ sikurezza għas-sustanzi ta’ oriġini umana maħsubin għall-applikazzjoni umana
TEXT_ADOPTED · MT · 8 October 2024
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Kvalitets- och säkerhetsstandarder för ämnen av mänskligt ursprung avsedda för användning på människor
TEXT_ADOPTED · SV · 8 October 2024
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Standardi kvalitete i sigurnosti za tvari ljudskog podrijetla namijenjene primjeni kod ljudi
TEXT_ADOPTED · HR · 8 October 2024
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Kvalitātes un drošības standarti cilvēku izcelsmes vielām, kuras paredzēts izmantot cilvēkiem
TEXT_ADOPTED · LV · 8 October 2024
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Normy jakości i bezpieczeństwa substancji pochodzenia ludzkiego przeznaczonych do zastosowania u ludzi
TEXT_ADOPTED · PL · 8 October 2024
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Normas de calidad y seguridad de las sustancias de origen humano destinadas a su aplicación en el ser humano
TEXT_ADOPTED · ES · 8 October 2024
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Standardy kvality a bezpečnosti pro látky lidského původu určené k použití u člověka
TEXT_ADOPTED · CS · 8 October 2024
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Normas de qualidade e segurança para as substâncias de origem humana destinadas à aplicação em seres humanos
TEXT_ADOPTED · PT · 8 October 2024
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Inimkasutuseks ettenähtud inimpäritolu materjali kvaliteedi- ja ohutusnõuded
TEXT_ADOPTED · ET · 8 October 2024
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Qualitäts- und Sicherheitsstandards für zur Verwendung beim Menschen bestimmte Substanzen menschlichen Ursprungs
TEXT_ADOPTED · DE · 8 October 2024
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Ihmisessä käytettäväksi tarkoitettujen ihmisperäisten aineiden laatu- ja turvallisuusvaatimukset
TEXT_ADOPTED · FI · 8 October 2024
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Caighdeáin cháilíochta agus sábháilteachta le haghaidh substaintí de bhunús daonna a bheartaítear lena n-úsáid sa duine
TEXT_ADOPTED · GA · 8 October 2024
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Standards of quality and safety for substances of human origin intended for human application
TEXT_ADOPTED · EN · 8 October 2024
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Kvalitets- og sikkerhedsstandarder for substanser af menneskelig oprindelse bestemt til anvendelse i mennesker
TEXT_ADOPTED · DA · 8 October 2024
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Az emberi felhasználásra szánt emberi eredetű anyagokra vonatkozó minőségi és biztonsági előírások
TEXT_ADOPTED · HU · 8 October 2024
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Standardi kakovosti in varnosti za snovi človeškega izvora, namenjene za uporabo na ljudeh
TEXT_ADOPTED · SL · 8 October 2024
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Normes de qualité et de sécurité des substances d’origine humaine destinées à une application humaine
TEXT_ADOPTED · FR · 8 October 2024
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Kwaliteits- en veiligheidsnormen voor stoffen van menselijke oorsprong die bestemd zijn voor toepassing op de mens
TEXT_ADOPTED · NL · 8 October 2024
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Kvalitets- och säkerhetsstandarder för ämnen av mänskligt ursprung avsedda för användning på människor
TEXT_ADOPTED · SV · 25 September 2024
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Normas de qualidade e segurança para as substâncias de origem humana destinadas à aplicação em seres humanos
TEXT_ADOPTED · PT · 25 September 2024
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Kvalitets- og sikkerhedsstandarder for substanser af menneskelig oprindelse bestemt til anvendelse i mennesker
TEXT_ADOPTED · DA · 24 September 2024
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Normy jakości i bezpieczeństwa substancji pochodzenia ludzkiego przeznaczonych do zastosowania u ludzi
TEXT_ADOPTED · PL · 23 September 2024
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Qualitäts- und Sicherheitsstandards für zur Verwendung beim Menschen bestimmte Substanzen menschlichen Ursprungs
TEXT_ADOPTED · DE · 20 September 2024
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Parametri di qualità e sicurezza per le sostanze di origine umana destinate all'applicazione sugli esseri umani
TEXT_ADOPTED · IT · 20 September 2024
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Caighdeáin cháilíochta agus sábháilteachta le haghaidh substaintí de bhunús daonna a bheartaítear lena n-úsáid sa duine
TEXT_ADOPTED · GA · 19 September 2024
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Kvalitātes un drošības standarti cilvēku izcelsmes vielām, kuras paredzēts izmantot cilvēkiem
TEXT_ADOPTED · LV · 17 September 2024
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Inimkasutuseks ettenähtud inimpäritolu materjali kvaliteedi- ja ohutusnõuded
TEXT_ADOPTED · ET · 16 September 2024
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Ihmisessä käytettäväksi tarkoitettujen ihmisperäisten aineiden laatu- ja turvallisuusvaatimukset
TEXT_ADOPTED · FI · 11 September 2024
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Normes de qualité et de sécurité des substances d’origine humaine destinées à une application humaine
TEXT_ADOPTED · FR · 11 September 2024
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Normas de calidad y seguridad de las sustancias de origen humano destinadas a su aplicación en el ser humano
TEXT_ADOPTED · ES · 10 September 2024
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Πρότυπα ποιότητας και ασφάλειας για τις ουσίες ανθρώπινης προέλευσης που προορίζονται για χρήση στον άνθρωπο
TEXT_ADOPTED · EL · 10 September 2024
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Standardi kvalitete i sigurnosti za tvari ljudskog podrijetla namijenjene primjeni kod ljudi
TEXT_ADOPTED · HR · 10 September 2024
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Standarde de calitate și siguranță pentru substanțele de origine umană destinate utilizării la om
TEXT_ADOPTED · RO · 9 September 2024
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Normy kvality a bezpečnosti pre látky ľudského pôvodu určené na humánne použitie
TEXT_ADOPTED · SK · 9 September 2024
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Kwaliteits- en veiligheidsnormen voor stoffen van menselijke oorsprong die bestemd zijn voor toepassing op de mens
TEXT_ADOPTED · NL · 9 September 2024
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Standardi kakovosti in varnosti za snovi človeškega izvora, namenjene za uporabo na ljudeh
TEXT_ADOPTED · SL · 5 September 2024
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Standardy kvality a bezpečnosti pro látky lidského původu určené k použití u člověka
TEXT_ADOPTED · CS · 5 September 2024
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Standards ta’ kwalità u ta’ sikurezza għas-sustanzi ta’ oriġini umana maħsubin għall-applikazzjoni umana
TEXT_ADOPTED · MT · 5 September 2024
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Стандарти за качество и безопасност на субстанциите от човешки произход, предназначени за приложение при човека
TEXT_ADOPTED · BG · 5 September 2024
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Az emberi felhasználásra szánt emberi eredetű anyagokra vonatkozó minőségi és biztonsági előírások
TEXT_ADOPTED · HU · 5 September 2024
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Iš žmogaus gautų medžiagų, skirtų naudoti žmogui, kokybės ir saugos standartai
TEXT_ADOPTED · LT · 3 September 2024
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Suite donnée au T9-0299/2023
ACT_FOLLOWUP · FR · 9 August 2024
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Sponsors
- Nathalie COLIN-OESTERLÉ · PPE · RAPPORTEUR
- · ENVI · COMMITTEE_LEAD
- Nicolás GONZÁLEZ CASARES · S&D · RAPPORTEUR_SHADOW
- Tilly METZ · Verts/ALE · RAPPORTEUR_SHADOW
- Andreas GLÜCK · Renew · RAPPORTEUR_SHADOW
- Kateřina KONEČNÁ · The Left · RAPPORTEUR_SHADOW
- Joanna KOPCIŃSKA · ECR · RAPPORTEUR_SHADOW
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Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2022%2F0216(COD)
- Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2022-0216
- eu · 2022-0216 · source updated 17 July 2024