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

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

11 September 2023
referral
Source: REFERRAL
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
13 October 2023
committee tabling report
Source: COMMITTEE_TABLING_REPORT
13 November 2023
committee tabling amendment
Source: COMMITTEE_TABLING_AMENDMENT
24 January 2024
committee adopting report
Source: COMMITTEE_ADOPTING_REPORT
31 January 2024
tabling plenary
Source: TABLING_PLENARY
27 February 2024
Plenary debate
Source: PLENARY_DEBATE
27 February 2024
Plenary debate
Source: PLENARY_DEBATE
28 February 2024
Plenary vote
Source: PLENARY_VOTE
28 February 2024
Vote results
Source: PLENARY_VOTE_RESULTS
28 February 2024
plenary amend proposal
Source: PLENARY_AMEND_PROPOSAL
28 February 2024
Plenary vote
Source: PLENARY_VOTE

Votes

No vote records are attached yet.

Versions

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Documents

129 official files

Follow up to T9-0097/2024

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Follow up to T9-0097/2024
ACT_FOLLOWUP · EN · 9 July 2024
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POPRAWKI 63–230 - Projekt sprawozdania Jednolite dodatkowe świadectwo ochronne dla produktów leczniczych oraz zmiana rozporządzenia (UE) 2017/1001, rozporządzenia (WE) nr 1901/2006 i rozporządzenia (UE) nr 608/2013
AMENDMENT_LIST · PL · 11 December 2023
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POPRAWKI 63–230 - Projekt sprawozdania Jednolite dodatkowe świadectwo ochronne dla produktów leczniczych oraz zmiana rozporządzenia (UE) 2017/1001, rozporządzenia (WE) nr 1901/2006 i rozporządzenia (UE) nr 608/2013
AMENDMENT_LIST · PL · 11 December 2023
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EMENDAMENTI 63 - 230 - Progetto di relazione Certificato complementare unitario per i medicinali e modifica dei regolamenti (UE) 2017/1001, (CE) n. 1901/2006 e (UE) n. 608/2013
AMENDMENT_LIST · IT · 11 December 2023
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EMENDAMENTI 63 - 230 - Progetto di relazione Certificato complementare unitario per i medicinali e modifica dei regolamenti (UE) 2017/1001, (CE) n. 1901/2006 e (UE) n. 608/2013
AMENDMENT_LIST · IT · 11 December 2023
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AMENDEMENTEN 63 - 230 - Ontwerpverslag Aanvullend beschermingscertificaat met eenheidswerking voor geneesmiddelen en wijziging van Verordening (EU) 2017/1001, Verordening (EG) nr. 1901/2006 en Verordening (EU) nr. 608/2013
AMENDMENT_LIST · NL · 11 December 2023
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AMENDEMENTEN 63 - 230 - Ontwerpverslag Aanvullend beschermingscertificaat met eenheidswerking voor geneesmiddelen en wijziging van Verordening (EU) 2017/1001, Verordening (EG) nr. 1901/2006 en Verordening (EU) nr. 608/2013
AMENDMENT_LIST · NL · 11 December 2023
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ÆNDRINGSFORSLAG 63 - 230 - Udkast til betænkning 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
AMENDMENT_LIST · DA · 11 December 2023
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ÆNDRINGSFORSLAG 63 - 230 - Udkast til betænkning 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
AMENDMENT_LIST · DA · 11 December 2023
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ИЗМЕНЕНИЯ 63 - 230 - Проект на доклад Единен сертификат за допълнителна закрила на лекарствените продукти и за изменение на Регламент (ЕС) 2017/1001, Регламент (ЕО) № 1901/2006 и Регламент (ЕС) № 608/2013
AMENDMENT_LIST · BG · 11 December 2023
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ИЗМЕНЕНИЯ 63 - 230 - Проект на доклад Единен сертификат за допълнителна закрила на лекарствените продукти и за изменение на Регламент (ЕС) 2017/1001, Регламент (ЕО) № 1901/2006 и Регламент (ЕС) № 608/2013
AMENDMENT_LIST · BG · 11 December 2023
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AMENDAMENTELE 63 - 230 - Proiect de raport privind certificatul suplimentar unitar pentru medicamente și de modificare a Regulamentului (UE) 2017/1001, a Regulamentului (CE) nr. 1901/2006 și a Regulamentului (UE) nr. 608/2013
AMENDMENT_LIST · RO · 11 December 2023
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AMENDAMENTELE 63 - 230 - Proiect de raport privind certificatul suplimentar unitar pentru medicamente și de modificare a Regulamentului (UE) 2017/1001, a Regulamentului (CE) nr. 1901/2006 și a Regulamentului (UE) nr. 608/2013
AMENDMENT_LIST · RO · 11 December 2023
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POZMĚŇOVACÍ NÁVRHY 63 - 230 - Návrh zprávy Jednotné dodatkové osvědčení pro léčivé přípravky a změna nařízení (EU) 2017/1001, nařízení (ES) č. 1901/2006 a nařízení (EU) č. 608/2013
AMENDMENT_LIST · CS · 11 December 2023
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POZMĚŇOVACÍ NÁVRHY 63 - 230 - Návrh zprávy Jednotné dodatkové osvědčení pro léčivé přípravky a změna nařízení (EU) 2017/1001, nařízení (ES) č. 1901/2006 a nařízení (EU) č. 608/2013
AMENDMENT_LIST · CS · 11 December 2023
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MUUDATUSETTEPANEKUD 63–230 - Raporti projekt Ravimite ühtse täiendava kaitse tunnistus ning määruse (EL) 2017/1001, määruse (EÜ) nr 1901/2006 ja määruse (EL) nr 608/2013 muutmine
AMENDMENT_LIST · ET · 11 December 2023
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MUUDATUSETTEPANEKUD 63–230 - Raporti projekt Ravimite ühtse täiendava kaitse tunnistus ning määruse (EL) 2017/1001, määruse (EÜ) nr 1901/2006 ja määruse (EL) nr 608/2013 muutmine
AMENDMENT_LIST · ET · 11 December 2023
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ALTERAÇÕES 63 - 230 - Projeto de relatório 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
AMENDMENT_LIST · PT · 8 December 2023
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ALTERAÇÕES 63 - 230 - Projeto de relatório 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
AMENDMENT_LIST · PT · 8 December 2023
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AMANDMANI 63 – 230 - Nacrt izvješća Jedinstvena svjedodžba o dodatnoj zaštiti za lijekove i izmjena Uredbe (EU) 2017/1001, Uredbe (EZ) br. 1901/2006 i Uredbe (EU) br. 608/2013
AMENDMENT_LIST · HR · 8 December 2023
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AMANDMANI 63 – 230 - Nacrt izvješća Jedinstvena svjedodžba o dodatnoj zaštiti za lijekove i izmjena Uredbe (EU) 2017/1001, Uredbe (EZ) br. 1901/2006 i Uredbe (EU) br. 608/2013
AMENDMENT_LIST · HR · 8 December 2023
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TARKISTUKSET 63 - 230 - Mietintöluonnos Lääkkeiden yhtenäinen lisäsuojatodistus ja asetuksen (EU) 2017/1001, asetuksen (EY) N:o 1901/2006 ja asetuksen (EU) N:o 608/2013 muuttaminen
AMENDMENT_LIST · FI · 8 December 2023
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TARKISTUKSET 63 - 230 - Mietintöluonnos Lääkkeiden yhtenäinen lisäsuojatodistus ja asetuksen (EU) 2017/1001, asetuksen (EY) N:o 1901/2006 ja asetuksen (EU) N:o 608/2013 muuttaminen
AMENDMENT_LIST · FI · 8 December 2023
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AMENDEMENTS 63 - 230 - Projet de rapport Certificat complémentaire de protection unitaire pour les médicaments, et modifiant les règlements (UE) 2017/1001, (CE) nº 1901/2006 et (UE) nº 608/2013
AMENDMENT_LIST · FR · 24 November 2023
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AMENDEMENTS 63 - 230 - Projet de rapport Certificat complémentaire de protection unitaire pour les médicaments, et modifiant les règlements (UE) 2017/1001, (CE) nº 1901/2006 et (UE) nº 608/2013
AMENDMENT_LIST · FR · 24 November 2023
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ÄNDERUNGSANTRÄGE 63 - 230 - Entwurf eines Berichts 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
AMENDMENT_LIST · DE · 24 November 2023
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ÄNDERUNGSANTRÄGE 63 - 230 - Entwurf eines Berichts 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
AMENDMENT_LIST · DE · 24 November 2023
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ENMIENDAS 63 - 230 - Proyecto de informe 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
AMENDMENT_LIST · ES · 24 November 2023
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ENMIENDAS 63 - 230 - Proyecto de informe 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
AMENDMENT_LIST · ES · 24 November 2023
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AMENDMENTS 63 - 230 - Draft report 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
AMENDMENT_LIST · EN · 14 November 2023
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AMENDMENTS 63 - 230 - Draft report 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
AMENDMENT_LIST · EN · 14 November 2023
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FÖRSLAG TILL BETÄNKANDE om förslag till Europaparlamentets och rådets förordning om enhetligt tilläggsskydd för läkemedel och om ändring av förordningarna (EU) 2017/1001, (EG) nr 1901/2006 och (EU) nr 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · SV · 30 October 2023
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FÖRSLAG TILL BETÄNKANDE om förslag till Europaparlamentets och rådets förordning om enhetligt tilläggsskydd för läkemedel och om ändring av förordningarna (EU) 2017/1001, (EG) nr 1901/2006 och (EU) nr 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · SV · 30 October 2023
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ПРОЕКТ НА ДОКЛАД относно предложението за регламент на Европейския парламент и на Съвета относно единния сертификат за допълнителна закрила на лекарствени продукти и за изменение на Регламент (ЕС) 2017/1001, Регламент (ЕО) № 1901/2006 и Регламент (ЕС) № 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · BG · 30 October 2023
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ПРОЕКТ НА ДОКЛАД относно предложението за регламент на Европейския парламент и на Съвета относно единния сертификат за допълнителна закрила на лекарствени продукти и за изменение на Регламент (ЕС) 2017/1001, Регламент (ЕО) № 1901/2006 и Регламент (ЕС) № 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · BG · 30 October 2023
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PROIECT DE RAPORT referitor la propunerea de regulament a Parlamentului European și a Consiliului privind certificatul suplimentar unitar pentru medicamente și de modificare a Regulamentului (UE) 2017/1001, a Regulamentului (CE) nr. 1901/2006 și a Regulamentului (UE) nr. 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · RO · 30 October 2023
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PROIECT DE RAPORT referitor la propunerea de regulament a Parlamentului European și a Consiliului privind certificatul suplimentar unitar pentru medicamente și de modificare a Regulamentului (UE) 2017/1001, a Regulamentului (CE) nr. 1901/2006 și a Regulamentului (UE) nr. 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · RO · 30 October 2023
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OSNUTEK POROČILA o predlogu uredbe Evropskega parlamenta in Sveta o enotnem dodatnem certifikatu za zdravila in spremembi Uredbe (EU) 2017/1001, Uredbe (ES) št. 1901/2006 in Uredbe (EU) št. 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · SL · 30 October 2023
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OSNUTEK POROČILA o predlogu uredbe Evropskega parlamenta in Sveta o enotnem dodatnem certifikatu za zdravila in spremembi Uredbe (EU) 2017/1001, Uredbe (ES) št. 1901/2006 in Uredbe (EU) št. 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · SL · 30 October 2023
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PROYECTO DE INFORME sobre la propuesta de Reglamento del Parlamento Europeo y del Consejo relativo al 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
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · ES · 30 October 2023
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PROYECTO DE INFORME sobre la propuesta de Reglamento del Parlamento Europeo y del Consejo relativo al 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
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · ES · 30 October 2023
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NÁVRH ZPRÁVY k návrhu nařízení Evropského parlamentu a Rady o jednotném dodatkovém osvědčení pro léčivé přípravky a o změně nařízení (EU) 2017/1001, nařízení (ES) č. 1901/2006 a nařízení (EU) č. 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · CS · 30 October 2023
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NÁVRH ZPRÁVY k návrhu nařízení Evropského parlamentu a Rady o jednotném dodatkovém osvědčení pro léčivé přípravky a o změně nařízení (EU) 2017/1001, nařízení (ES) č. 1901/2006 a nařízení (EU) č. 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · CS · 30 October 2023
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JELENTÉSTERVEZET a gyógyszerek egységes kiegészítő oltalmi tanúsítványáról, valamint az (EU) 2017/1001 rendelet, az 1901/2006/EK rendelet és a 608/2013/EU rendelet módosításáról szóló európai parlamenti és tanácsi rendeletre irányuló javaslatról
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · HU · 30 October 2023
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JELENTÉSTERVEZET a gyógyszerek egységes kiegészítő oltalmi tanúsítványáról, valamint az (EU) 2017/1001 rendelet, az 1901/2006/EK rendelet és a 608/2013/EU rendelet módosításáról szóló európai parlamenti és tanácsi rendeletre irányuló javaslatról
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · HU · 30 October 2023
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NÁVRH SPRÁVY o návrhu nariadenia Európskeho parlamentu a Rady o jednotnom dodatkovom ochrannom osvedčení pre lieky, ktorým sa mení nariadenie (EÚ) 2017/1001, nariadenie (ES) č. 1901/2006, ako aj nariadenie (EÚ) č. 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · SK · 30 October 2023
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NÁVRH SPRÁVY o návrhu nariadenia Európskeho parlamentu a Rady o jednotnom dodatkovom ochrannom osvedčení pre lieky, ktorým sa mení nariadenie (EÚ) 2017/1001, nariadenie (ES) č. 1901/2006, ako aj nariadenie (EÚ) č. 608/2013
REPORT_PARLIAMENTARY_COMMITTEE_DRAFT · SK · 30 October 2023
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PROJET DE RAPPORT 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 · FR · 30 October 2023
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PROJET DE RAPPORT 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 · FR · 30 October 2023
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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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Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2023%2F0127(COD)
Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2023-0127
eu · 2023-0127 · source updated 28 February 2024