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European Union · Bill · COD

2023/0127(COD)

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

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

Records

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

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

129 official files

PRANEŠIMO PROJEKTAS dėl pasiūlymo dėl Europos Parlamento Ir Tarybos reglamento dėl bendrojo medicinos produktų papildomos apsaugos liudijimo, kuriuo iš dalies keičiamas Reglamentas (ES) 2017/1001, Reglamentas (EB) Nr. 1901/2006 ir Reglamentas (ES) Nr. 608/2013

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  • PRANEŠIMO PROJEKTAS dėl pasiūlymo dėl Europos Parlamento Ir Tarybos reglamento dėl bendrojo medicinos produktų papildomos apsaugos liudijimo, kuriuo iš dalies keičiamas Reglamentas (ES) 2017/1001, Reglamentas (EB) Nr. 1901/2006 ir Reglamentas (ES) Nr. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · LT · 30 October 2023

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  • ZIŅOJUMA PROJEKTS par priekšlikumu Eiropas Parlamenta un Padomes regulai par zāļu vienoto papildu aizsardzības sertifikātu un ar ko groza Regulu (ES) 2017/1001, Regulu (EK) Nr. 1901/2006, kā arī Regulu (ES) Nr. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · LV · 30 October 2023

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  • ZIŅOJUMA PROJEKTS par priekšlikumu Eiropas Parlamenta un Padomes regulai par zāļu vienoto papildu aizsardzības sertifikātu un ar ko groza Regulu (ES) 2017/1001, Regulu (EK) Nr. 1901/2006, kā arī Regulu (ES) Nr. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · LV · 30 October 2023

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  • MIETINTÖLUONNOS ehdotuksesta Euroopan parlamentin ja neuvoston asetukseksi lääkkeiden yhtenäisestä lisäsuojatodistuksesta ja asetuksen (EU) 2017/1001, asetuksen (EY) N:o 1901/2006 ja asetuksen (EU) N:o 608/2013 muuttamisesta

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · FI · 30 October 2023

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  • MIETINTÖLUONNOS ehdotuksesta Euroopan parlamentin ja neuvoston asetukseksi lääkkeiden yhtenäisestä lisäsuojatodistuksesta ja asetuksen (EU) 2017/1001, asetuksen (EY) N:o 1901/2006 ja asetuksen (EU) N:o 608/2013 muuttamisesta

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · FI · 30 October 2023

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  • PROJETO DE RELATÓRIO sobre a proposta de regulamento do Parlamento Europeu e do Conselho relativo ao certificado complementar de proteção unitário para os medicamentos, e que altera o Regulamento (UE) 2017/1001, o Regulamento (CE) n.º 1901/2006, bem como o Regulamento (UE) n.º 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · PT · 30 October 2023

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  • PROJETO DE RELATÓRIO sobre a proposta de regulamento do Parlamento Europeu e do Conselho relativo ao certificado complementar de proteção unitário para os medicamentos, e que altera o Regulamento (UE) 2017/1001, o Regulamento (CE) n.º 1901/2006, bem como o Regulamento (UE) n.º 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · PT · 30 October 2023

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  • ΣΧΕΔΙΟ ΕΚΘΕΣΗΣ σχετικά με την πρόταση κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου που αφορά το ενιαίο συμπληρωματικό πιστοποιητικό για τα φάρμακα και την τροποποίηση του κανονισμού (ΕΕ) 2017/1001, του κανονισμού (ΕΚ) αριθ. 1901/2006 καθώς και του κανονισμού (ΕΕ) αριθ. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · EL · 30 October 2023

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  • ΣΧΕΔΙΟ ΕΚΘΕΣΗΣ σχετικά με την πρόταση κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου που αφορά το ενιαίο συμπληρωματικό πιστοποιητικό για τα φάρμακα και την τροποποίηση του κανονισμού (ΕΕ) 2017/1001, του κανονισμού (ΕΚ) αριθ. 1901/2006 καθώς και του κανονισμού (ΕΕ) αριθ. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · EL · 30 October 2023

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  • ENTWURF EINES BERICHTS über den Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über das einheitliche zusätzliche Zertifikat für Arzneimittel und zur Änderung der Verordnung (EU) 2017/1001, der Verordnung (EG) Nr. 1901/2006 und der Verordnung (EU) Nr. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · DE · 30 October 2023

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  • ENTWURF EINES BERICHTS über den Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über das einheitliche zusätzliche Zertifikat für Arzneimittel und zur Änderung der Verordnung (EU) 2017/1001, der Verordnung (EG) Nr. 1901/2006 und der Verordnung (EU) Nr. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · DE · 30 October 2023

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  • PROJEKT SPRAWOZDANIA w sprawie wniosku dotyczącego rozporządzenia Parlamentu Europejskiego i Rady w sprawie jednolitego dodatkowego świadectwa ochronnego dla produktów leczniczych oraz zmieniającego rozporządzenie (UE) 2017/1001, rozporządzenie (WE) nr 1901/2006 i rozporządzenie (UE) nr 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · PL · 30 October 2023

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  • PROJEKT SPRAWOZDANIA w sprawie wniosku dotyczącego rozporządzenia Parlamentu Europejskiego i Rady w sprawie jednolitego dodatkowego świadectwa ochronnego dla produktów leczniczych oraz zmieniającego rozporządzenie (UE) 2017/1001, rozporządzenie (WE) nr 1901/2006 i rozporządzenie (UE) nr 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · PL · 30 October 2023

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  • RAPORTI PROJEKT ettepaneku kohta võtta vastu Euroopa Parlamendi ja nõukogu määrus, milles käsitletakse ravimite ühtset täiendava kaitse tunnistust ning millega muudetakse määrust (EL) 2017/1001, määrust (EÜ) nr 1901/2006 ja määrust (EL) nr 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · ET · 30 October 2023

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  • RAPORTI PROJEKT ettepaneku kohta võtta vastu Euroopa Parlamendi ja nõukogu määrus, milles käsitletakse ravimite ühtset täiendava kaitse tunnistust ning millega muudetakse määrust (EL) 2017/1001, määrust (EÜ) nr 1901/2006 ja määrust (EL) nr 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · ET · 30 October 2023

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  • ONTWERPVERSLAG over het voorstel voor een verordening van het Europees Parlement en de Raad betreffende het aanvullende beschermingscertificaat met eenheidswerking voor geneesmiddelen en tot wijziging van Verordening (EU) 2017/1001, Verordening (EG) nr. 1901/2006 en Verordening (EU) nr. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · NL · 27 October 2023

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  • ONTWERPVERSLAG over het voorstel voor een verordening van het Europees Parlement en de Raad betreffende het aanvullende beschermingscertificaat met eenheidswerking voor geneesmiddelen en tot wijziging van Verordening (EU) 2017/1001, Verordening (EG) nr. 1901/2006 en Verordening (EU) nr. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · NL · 27 October 2023

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  • NACRT IZVJEŠĆA o Prijedlogu uredbe Europskog parlamenta i Vijeća o jedinstvenoj svjedodžbi o dodatnoj zaštiti za lijekove i izmjeni Uredbe (EU) 2017/1001, Uredbe (EZ) br. 1901/2006 i Uredbe (EU) br. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · HR · 27 October 2023

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  • NACRT IZVJEŠĆA o Prijedlogu uredbe Europskog parlamenta i Vijeća o jedinstvenoj svjedodžbi o dodatnoj zaštiti za lijekove i izmjeni Uredbe (EU) 2017/1001, Uredbe (EZ) br. 1901/2006 i Uredbe (EU) br. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · HR · 27 October 2023

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  • PROGETTO DI RELAZIONE sulla proposta di regolamento del Parlamento europeo e del Consiglio sul certificato complementare unitario per i medicinali, che modifica i regolamenti (UE) 2017/1001, (CE) n. 1901/2006 e (UE) n. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · IT · 27 October 2023

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  • PROGETTO DI RELAZIONE sulla proposta di regolamento del Parlamento europeo e del Consiglio sul certificato complementare unitario per i medicinali, che modifica i regolamenti (UE) 2017/1001, (CE) n. 1901/2006 e (UE) n. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · IT · 27 October 2023

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  • ABBOZZ TA’ RAPPORT dwar il-proposta għal regolament tal-Parlament Ewropew u tal-Kunsill dwar iċ-ċertifikat supplimentari unitarju għall-prodotti mediċinali, u li jemenda r-Regolament (UE) 2017/1001, ir-Regolament (KE) Nru 1901/2006 kif ukoll ir-Regolament (UE) Nru 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · MT · 26 October 2023

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  • ABBOZZ TA’ RAPPORT dwar il-proposta għal regolament tal-Parlament Ewropew u tal-Kunsill dwar iċ-ċertifikat supplimentari unitarju għall-prodotti mediċinali, u li jemenda r-Regolament (UE) 2017/1001, ir-Regolament (KE) Nru 1901/2006 kif ukoll ir-Regolament (UE) Nru 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · MT · 26 October 2023

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  • DRÉACHT-TUARASCÁIL ar an togra le haghaidh rialachán ó Pharlaimint na hEorpa agus ón gComhairle maidir leis an 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

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · GA · 25 October 2023

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  • DRÉACHT-TUARASCÁIL ar an togra le haghaidh rialachán ó Pharlaimint na hEorpa agus ón gComhairle maidir leis an 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

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · GA · 25 October 2023

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  • UDKAST TIL BETÆNKNING om forslag til Europa-Parlamentets og Rådets forordning om det fælles supplerende beskyttelsescertifikat for lægemidler og om ændring af forordning (EU) 2017/1001, forordning (EF) nr. 1901/2006 og forordning (EU) nr. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · DA · 24 October 2023

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  • UDKAST TIL BETÆNKNING om forslag til Europa-Parlamentets og Rådets forordning om det fælles supplerende beskyttelsescertifikat for lægemidler og om ændring af forordning (EU) 2017/1001, forordning (EF) nr. 1901/2006 og forordning (EU) nr. 608/2013

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · DA · 24 October 2023

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  • DRAFT REPORT on the proposal for a regulation of the European Parliament and of the Council on the 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

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · EN · 18 October 2023

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  • DRAFT REPORT on the proposal for a regulation of the European Parliament and of the Council on the 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

    REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · EN · 18 October 2023

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