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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

votedEuropean Union· European Parliament· EN

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

  1. 12 September 2022

    referral

    Source: REFERRAL

  2. 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

  3. 18 January 2023

    committee tabling report

    Source: COMMITTEE_TABLING_REPORT

  4. 18 July 2023

    committee adopting report

    Source: COMMITTEE_ADOPTING_REPORT

  5. 26 July 2023

    tabling plenary

    Source: TABLING_PLENARY

  6. 12 September 2023

    Plenary vote

    Source: PLENARY_VOTE

  7. 12 September 2023

    Vote results

    Source: PLENARY_VOTE_RESULTS

  8. 12 September 2023

    plenary amend

    Source: PLENARY_AMEND

  9. 12 September 2023

    Referred for interinstitutional negotiations

    Source: PLENARY_REFER_COMMITTEE_INTERINSTITUTIONAL_NEGOTIATIONS

  10. 12 September 2023

    Plenary vote

    Source: PLENARY_VOTE

  11. 14 February 2024

    committee approve provisional agreement

    Source: COMMITTEE_APPROVE_PROVISIONAL_AGREEMENT

  12. 24 April 2024

    Vote results

    Source: PLENARY_VOTE_RESULTS

  13. 24 April 2024

    Plenary vote

    Source: PLENARY_VOTE

  14. 24 April 2024

    plenary amend proposal

    Source: PLENARY_AMEND_PROPOSAL

  15. 24 April 2024

    Plenary vote

    Source: PLENARY_VOTE

  16. 13 June 2024

    signature

    Source: SIGNATURE

  17. 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

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  • 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

    ViewDownloadOpen at official source

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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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