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
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
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
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
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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Sponsors
- Javier ZARZALEJOS · PPE · RAPPORTEUR_SHADOW
- · JURI · COMMITTEE_LEAD
- · IMCO · COMMITTEE_OPINION
- Marie TOUSSAINT · Verts/ALE · RAPPORTEUR_SHADOW
- Emmanuel MAUREL · The Left · RAPPORTEUR_SHADOW
- · ENVI · COMMITTEE_OPINION
- · INTA · COMMITTEE_OPINION
- Adrián VÁZQUEZ LÁZARA · Renew · RAPPORTEUR_SHADOW
- Tiemo WÖLKEN · S&D · RAPPORTEUR
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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