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Unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013

Original

votedEuropean Union· European Parliament· EN

Introduced

11 September 2023

Last action

28 February 2024 · Plenary vote

Status

PLENARY_VOTE

Sponsors

Subjects

Discovery layer

Source updated

28 February 2024

Official titles

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

23 official languages
  • Bulgarian

    Единен допълнителен сертификат за лекарствени продукти и изменение на Регламент (ЕС) 2017/1001, Регламент (ЕО) № 1901/2006 и Регламент (ЕС) № 608/2013

  • Czech

    Jednotné dodatkové osvědčení pro léčivé přípravky a změna nařízení (EU) 2017/1001, nařízení (ES) č. 1901/2006 a nařízení (EU) č. 608/2013

  • Danish

    Fælles supplerende beskyttelsescertifikat for lægemidler og ændring af forordning (EU) 2017/1001, forordning (EF) nr. 1901/2006 og forordning (EU) nr. 608/2013

  • German

    Einheitliches ergänzendes Zertifikat für Arzneimittel und Änderung der Verordnung (EU) 2017/1001, der Verordnung (EG) Nr. 1901/2006 und der Verordnung (EU) Nr. 608/2013

  • Greek

    Ενιαίο συμπληρωματικό πιστοποιητικό για τα φάρμακα, και τροποποίηση του κανονισμού (ΕΕ) 2017/1001, του κανονισμού (ΕΚ) αριθ. 1901/2006 και του κανονισμού (ΕΕ) αριθ. 608/2013

  • Spanish

    Certificado complementario unitario para los medicamentos y por el que se modifican el Reglamento (UE) 2017/1001, el Reglamento (CE) n.º 1901/2006 y el Reglamento (UE) n.º 608/2013

  • Estonian

    Ravimite ühtse täiendava kaitse tunnistus ning määruse (EL) 2017/1001, määruse (EÜ) nr 1901/2006 ja määruse (EL) nr 608/2013 muutmine

  • Finnish

    Lääkkeiden yhtenäinen lisäsuojatodistus ja asetuksen (EU) 2017/1001, asetuksen (EY) N:o 1901/2006 ja asetuksen (EU) N:o 608/2013 muuttaminen

  • French

    Certificat complémentaire de protection unitaire, et modifiant le règlement (UE) 2017/1001, le règlement (CE) nº 1901/2006 ainsi que le règlement (UE) nº 608/2013

  • Irish

    Deimhniú forlíontach aonadach le haghaidh táirgí íocshláinte, agus lena leasaítear Rialachán (AE) 2017/1001, Rialachán (CE) Uimh. 1901/2006 chomh maith le Rialachán (AE) Uimh. 608/2013

  • Croatian

    Jedinstvena svjedodžba o dodatnoj zaštiti za lijekove te izmjena Uredbe (EU) 2017/1001, Uredbe (EZ) br. 1901/2006 i Uredbe (EU) br. 608/2013

  • Hungarian

    Gyógyszerekre vonatkozó egységes kiegészítő oltalmi tanúsítvány, valamint az (EU) 2017/1001 rendelet, az 1901/2006/EK rendelet és a 608/2013/EU rendelet módosítása

  • Italian

    Certificato complementare unitario per i medicinali e modifica del regolamento (UE) 2017/1001, del regolamento (CE) n. 1901/2006 e del regolamento (UE) n. 608/2013

  • Lithuanian

    Bendrasis medicinos produktų papildomas apsaugos liudijimas ir Reglamento (ES) 2017/1001, Reglamento (EB) Nr. 1901/2006 ir Reglamento (ES) Nr. 608/2013 dalinis keitimas

  • Latvian

    Vienotais papildu aizsardzības sertifikāts zālēm un Regulas (ES) 2017/1001, Regulas (EK) Nr.1901/2006, kā arī Regulas (ES) Nr. 608/2013 grozīšana

  • Maltese

    Iċ-ċertifikat supplimentari unitarju għall-prodotti mediċinali, u emenda tar-Regolament (UE) 2017/1001, ir-Regolament (KE) Nru 1901/2006 kif ukoll ir-Regolament (UE) Nru 608/2013

  • Dutch

    Aanvullend beschermingscertificaat met eenheidswerking voor geneesmiddelen en wijziging van Verordening (EU) 2017/1001, Verordening (EG) nr. 1901/2006 en Verordening (EU) nr. 608/2013

  • Polish

    Jednolite dodatkowe świadectwo ochronne dla produktów leczniczych oraz zmiana rozporządzenia (UE) 2017/1001, rozporządzenia (WE) nr 1901/2006 i rozporządzenia (UE) nr 608/2013

  • Portuguese

    Certificado complementar de proteção unitário para os medicamentos, alterando o Regulamento (UE) 2017/1001, o Regulamento (CE) n.º 1901/2006, bem como o Regulamento (UE) n.º 608/2013

  • Romanian

    Certificatul suplimentar unitar pentru medicamente și modificarea Regulamentului (UE) 2017/1001, a Regulamentului (CE) nr. 1901/2006 și a Regulamentului (UE) nr. 608/2013

  • Slovak

    Jednotné doplnkové osvedčenie pre liečivá a zmena nariadenia (EÚ) 2017/1001, nariadenia (ES) č. 1901/2006 a nariadenia (EÚ) č. 608/2013

  • Slovenian

    Enotni dodatni certifikat za zdravila in sprememba Uredbe (EU) 2017/1001, Uredbe (ES) št. 1901/2006 in Uredbe (EU) št. 608/2013

  • Swedish

    Enhetligt tilläggsskydd för läkemedel och ändring av förordningarna (EU) 2017/1001, (EG) nr 1901/2006 och (EU) nr 608/2013

Record

Official bill 2023/0127(COD) from European Union at European Parliament. Dated 11 September 2023. Status: PLENARY_VOTE.

Timeline

  1. 11 September 2023

    referral

    Source: REFERRAL

  2. 11 September 2023

    Introduced

    Unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013

    Source: COD

  3. 13 October 2023

    committee tabling report

    Source: COMMITTEE_TABLING_REPORT

  4. 13 November 2023

    committee tabling amendment

    Source: COMMITTEE_TABLING_AMENDMENT

  5. 24 January 2024

    committee adopting report

    Source: COMMITTEE_ADOPTING_REPORT

  6. 31 January 2024

    tabling plenary

    Source: TABLING_PLENARY

  7. 27 February 2024

    Plenary debate

    Source: PLENARY_DEBATE

  8. 27 February 2024

    Plenary debate

    Source: PLENARY_DEBATE

  9. 28 February 2024

    Plenary vote

    Source: PLENARY_VOTE

  10. 28 February 2024

    Vote results

    Source: PLENARY_VOTE_RESULTS

  11. 28 February 2024

    plenary amend proposal

    Source: PLENARY_AMEND_PROPOSAL

  12. 28 February 2024

    Plenary vote

    Source: PLENARY_VOTE

Votes

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Documents

129 official files

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Sources

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