Amending Directives 2001/20/EC and 2001/83/EC as regards derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland, as well as in Cyprus, Ireland and Malta

votedEuropean Union· European Parliament· EN

Introduced

20 January 2022

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20 April 2022 · publication official journal

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PLENARY_VOTE

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23 official languages

Bulgarian
Изменение на директиви 2001/20/ЕО и 2001/83/ЕО по отношение на дерогациите от някои задължения, свързани с определени лекарствени продукти за хуманна употреба, които се предлагат в Обединеното кралство по отношение на Северна Ирландия, както и в Ирландия, Кипър и Малта
Czech
Změna směrnic 2001/20/ES a 2001/83/ES, pokud jde o výjimky z některých povinností týkajících se určitých humánních léčivých přípravků uvedených na trh ve Spojeném království, s ohledem na Severní Irsko, Kypr, Irsko a Maltu
Danish
Ændring af direktiv 2001/20/EF og 2001/83/EF for så vidt angår undtagelser fra visse forpligtelser vedrørende visse humanmedicinske lægemidler, der gøres tilgængelige i Det Forenede Kongerige for så vidt angår Nordirland samt Cypern, Irland og Malta
German
Änderung der Richtlinien 2001/20/EG und 2001/83/EG in Bezug auf Ausnahmen von bestimmten Verpflichtungen für bestimmte im Vereinigten Königreich bereitgestellte Humanarzneimittel in Bezug auf Nordirland sowie in Bezug auf Zypern, Irland und Malta
Greek
Τροποποίηση των οδηγιών 2001/20/ΕΚ και 2001/83/ΕΚ όσον αφορά παρεκκλίσεις από ορισμένες υποχρεώσεις σχετικές με ορισμένα φάρμακα για ανθρώπινη χρήση, διαθέσιμα στο Ηνωμένο Βασίλειο, όσον αφορά τη Βόρεια Ιρλανδία, καθώς και στην Κύπρο, την Ιρλανδία και τη Μάλτα
Spanish
Modificación de la Directiva 2001/20/CE y de la Directiva 2001/83/CE en lo que concierne a excepciones respecto a ciertas obligaciones relativas a determinados medicamentos de uso humano disponibles en el Reino Unido con respecto a Irlanda del Norte, así como en Chipre, Irlanda y Malta
Estonian
Direktiivide 2001/20/EÜ ja 2001/83/EÜ muutmine seoses eranditega teatavatest kohustustest teatavate inimtervishoius kasutatavate ravimite puhul, mis on tehtud kättesaadavaks Ühendkuningriigis seoses Põhja-Iirimaaga ning Küprosel, Iirimaal ja Maltal
Finnish
Direktiivien 2001/20/EY ja 2001/83/EY muuttaminen siltä osin kuin on kyse poikkeuksista tiettyihin velvoitteisiin, jotka koskevat tiettyjä Yhdistyneessä kuningaskunnassa Pohjois-Irlannin osalta sekä Kyproksessa, Irlannissa ja Maltassa saataville asetettavia ihmisille tarkoitettuja lääkkeitä
French
Modification des directives 2001/20/CE et 2001/83/CE en ce qui concerne des dérogations à certaines obligations relatives à des médicaments à usage humain disponibles au Royaume-Uni en ce qui concerne l'Irlande du Nord, ainsi qu'à Chypre, en Irlande et à Malte
Irish
Leasú a dhéanamh ar Threoracha 2001/20/CE agus 2001/83/CE maidir le díolúintí ó oibleagáidí ar leith a bhaineann le táirgí íocshláinte áirithe lena n-úsáid ag an duine a chuirtear ar fáil sa Ríocht Aontaithe i leith Thuaisceart Éireann, mar aon le sa Chipir, in Éirinn agus i Málta
Croatian
Izmjene direktiva 2001/20/EZ i 2001/83/EZ u pogledu odstupanja od određenih obveza u vezi s određenim lijekovima za humanu uporabu koji se stavljaju u promet u Ujedinjenoj Kraljevini u vezi sa Sjevernom Irskom te u Cipru, Irskoj i Malti
Hungarian
A 2001/20/EK és a 2001/83/EK irányelvnek az Egyesült Királyságban forgalmazott egyes emberi felhasználásra szánt gyógyszerkészítményekre vonatkozó egyes kötelezettségektől való eltérések tekintetében Észak-Írország, valamint Ciprus, Írország és Málta vonatkozásában történő módosítása
Italian
Modifica delle direttive 2001/20/CE e 2001/83/CE per quanto riguarda le deroghe a determinati obblighi concernenti determinati medicinali per uso umano resi disponibili nel Regno Unito nei confronti dell'Irlanda del Nord, nonché a Cipro, in Irlanda e a Malta
Lithuanian
Direktyvų 2001/20/EB ir 2001/83/EB nuostatų, leidžiančių nukrypti nuo tam tikrų įpareigojimų, susijusių su tam tikrais žmonėms skirtais vaistais, tiekiamais Jungtinėje Karalystėje, kiek tai susiję su Šiaurės Airija, taip pat Kipre, Airijoje ir Maltoje, dalinis keitimas
Latvian
Grozījumu izdarīšana Direktīvā 2001/20/EK un Direktīvā 2001/83/EK attiecībā uz atkāpēm no noteiktiem pienākumiem saistībā ar noteiktām cilvēkiem paredzētām zālēm, ko dara pieejamas Apvienotajā Karalistē attiecībā uz Ziemeļīriju, kā arī Kiprā, Īrijā un Maltā
Maltese
Emenda tad-Direttivi 2001/20/KE u 2001/83/KE fir-rigward ta' derogi minn ċerti obbligi li jikkonċernaw id-disponibbiltà ta' ċerti prodotti mediċinali għall-użu mill-bniedem fir-Renju Unit fir-rigward tal-Irlanda ta' Fuq, kif ukoll f'Ċipru, fl-Irlanda u f'Malta
Dutch
Wijziging van Richtlijnen 2001/20/EG en 2001/83/EG wat betreft afwijkingen van bepaalde verplichtingen met betrekking tot bepaalde geneesmiddelen voor menselijk gebruik die in het Verenigd Koninkrijk met betrekking tot Noord-Ierland en in Cyprus, Ierland en Malta verkrijgbaar worden gesteld
Polish
Zmiana dyrektyw 2001/20/WE i 2001/83/WE w odniesieniu do odstępstw od niektórych obowiązków dotyczących niektórych produktów leczniczych stosowanych u ludzi udostępnianych w Zjednoczonym Królestwie w odniesieniu do Irlandii Północnej, jak również na Cyprze, w Irlandii i na Malcie
Portuguese
Alteração das diretivas 2001/20/CE e 2001/83/CE no que diz respeito às derrogações a certas obrigações relativas a determinados medicamentos para uso humano disponíveis no Reino Unido no que respeita à Irlanda do Norte, a Chipre, à Irlanda e a Malta
Romanian
Modificarea Directivelor 2001/20/CE și 2001/83/CE ca urmare a derogărilor de la anumite obligații privind anumite medicamente de uz uman în Regatul Unit, privind Irlanda de Nord, precum și în Cipru, Irlanda și Malta
Slovak
Zmena smerníc 2001/20/ES and 2001/83/ES, pokiaľ ide o výnimky z určitých povinností týkajúcich sa určitých liekov na humánne použitie sprístupnených v Spojenom kráľovstve, pokiaľ ide o Severné Írsko, ako aj na Cypre, v Írsku a na Malte
Slovenian
Sprememba direktiv 2001/20/ES in 2001/83/ES glede odstopanj od nekaterih obveznosti v zvezi z nekaterimi zdravili za uporabo v humani medicini, ki so na voljo v Združenem kraljestvu v zvezi s Severno Irsko ter na Cipru, Irskem in Malti
Swedish
Ändring av direktiven 2001/83/EG och 2001/20/EG vad gäller undantag från vissa skyldigheter avseende vissa humanläkemedel som tillhandahålls i Förenade kungariket med avseende på Nordirland samt i Cypern, Irland och Malta

Records

Official bill 2021/0431(COD) from European Union at European Parliament. Dated 20 January 2022. Status: PLENARY_VOTE.

Timeline

20 January 2022
referral
Source: REFERRAL
20 January 2022
Introduced
Amending Directives 2001/20/EC and 2001/83/EC as regards derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland, as well as in Cyprus, Ireland and Malta
Source: COD
5 April 2022
Plenary vote
Source: PLENARY_VOTE
7 April 2022
plenary amend proposal
Source: PLENARY_AMEND_PROPOSAL
7 April 2022
Vote results
Source: PLENARY_VOTE_RESULTS
7 April 2022
Plenary vote
Source: PLENARY_VOTE
12 April 2022
signature
Source: SIGNATURE
20 April 2022
publication official journal
Source: PUBLICATION_OFFICIAL_JOURNAL

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Documents

74 official files

Zdravila, ki so na voljo v Združenem kraljestvu v zvezi s Severno Irsko ter na Cipru, Irskem in Malti ***I

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Zdravila, ki so na voljo v Združenem kraljestvu v zvezi s Severno Irsko ter na Cipru, Irskem in Malti ***I
TEXT_ADOPTED · SL · 7 July 2022
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Zdravila, ki so na voljo v Združenem kraljestvu v zvezi s Severno Irsko ter na Cipru, Irskem in Malti ***I
TEXT_ADOPTED · SL · 7 July 2022
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Ravimid, mis on tehtud kättesaadavaks Ühendkuningriigis PõhjaIirimaa tarvis ning Küprosel, Iirimaal ja Maltal ***I
TEXT_ADOPTED · ET · 4 July 2022
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Ravimid, mis on tehtud kättesaadavaks Ühendkuningriigis PõhjaIirimaa tarvis ning Küprosel, Iirimaal ja Maltal ***I
TEXT_ADOPTED · ET · 4 July 2022
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Lieky sprístupnené v Spojenom kráľovstve, pokiaľ ide o Severné Írsko, na Cypre, v Írsku a na Malte ***I
TEXT_ADOPTED · SK · 1 July 2022
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Lieky sprístupnené v Spojenom kráľovstve, pokiaľ ide o Severné Írsko, na Cypre, v Írsku a na Malte ***I
TEXT_ADOPTED · SK · 1 July 2022
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Lægemidler, der gøres tilgængelige i Det Forenede Kongerige for så vidt angår Nordirland, Cypern, Irland og Malta ***I
TEXT_ADOPTED · DA · 1 July 2022
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Lægemidler, der gøres tilgængelige i Det Forenede Kongerige for så vidt angår Nordirland, Cypern, Irland og Malta ***I
TEXT_ADOPTED · DA · 1 July 2022
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Φάρμακα διαθέσιμα στο Ηνωμένο Βασίλειο σε σχέση με τη Βόρεια Ιρλανδία, την Κύπρο, την Ιρλανδία και τη Μάλτα ***I
TEXT_ADOPTED · EL · 1 July 2022
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Φάρμακα διαθέσιμα στο Ηνωμένο Βασίλειο σε σχέση με τη Βόρεια Ιρλανδία, την Κύπρο, την Ιρλανδία και τη Μάλτα ***I
TEXT_ADOPTED · EL · 1 July 2022
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Léčivé přípravky dodávané na trh ve Spojeném království s ohledem na Severní Irsko, na Kypru, v Irsku a na Maltě ***I
TEXT_ADOPTED · CS · 1 July 2022
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Léčivé přípravky dodávané na trh ve Spojeném království s ohledem na Severní Irsko, na Kypru, v Irsku a na Maltě ***I
TEXT_ADOPTED · CS · 1 July 2022
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Humanläkemedel som tillhandahålls i Förenade kungariket med avseende på Nordirland samt i Cypern, Irland och Malta ***I
TEXT_ADOPTED · SV · 30 June 2022
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Humanläkemedel som tillhandahålls i Förenade kungariket med avseende på Nordirland samt i Cypern, Irland och Malta ***I
TEXT_ADOPTED · SV · 30 June 2022
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Medicinali resi disponibili nel Regno Unito nei confronti dell'Irlanda del Nord, nonché a Cipro, in Irlanda e a Malta ***I
TEXT_ADOPTED · IT · 30 June 2022
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Medicinali resi disponibili nel Regno Unito nei confronti dell'Irlanda del Nord, nonché a Cipro, in Irlanda e a Malta ***I
TEXT_ADOPTED · IT · 30 June 2022
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Az Egyesült Királyságban forgalmazott gyógyszerek Észak-Írország, Ciprus, Írország és Málta vonatkozásában ***I
TEXT_ADOPTED · HU · 30 June 2022
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Az Egyesült Királyságban forgalmazott gyógyszerek Észak-Írország, Ciprus, Írország és Málta vonatkozásában ***I
TEXT_ADOPTED · HU · 30 June 2022
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Médicaments disponibles au Royaume-Uni en ce qui concerne l'Irlande du Nord, Chypre, l'Irlande et Malte ***I
TEXT_ADOPTED · FR · 30 June 2022
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Médicaments disponibles au Royaume-Uni en ce qui concerne l'Irlande du Nord, Chypre, l'Irlande et Malte ***I
TEXT_ADOPTED · FR · 30 June 2022
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Vaistai, tiekiami Jungtinėje Karalystėje, kiek tai susiję su Šiaurės Airija, taip pat Kipre, Airijoje ir Maltoje ***I
TEXT_ADOPTED · LT · 30 June 2022
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Vaistai, tiekiami Jungtinėje Karalystėje, kiek tai susiję su Šiaurės Airija, taip pat Kipre, Airijoje ir Maltoje ***I
TEXT_ADOPTED · LT · 30 June 2022
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Suite donnée au T9-0116/2022
ACT_FOLLOWUP · FR · 3 June 2022
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Follow up to T9-0116/2022
ACT_FOLLOWUP · EN · 3 June 2022
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Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2021%2F0431(COD)
Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2021-0431
eu · 2021-0431 · source updated 20 April 2022