Amendment to Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

adoptedEuropean Union· European Parliament· EN

Introduced

20 October 2014

Last action

7 January 2019 · publication official journal

Status

PLENARY_ADOPT_POSITION

Official titles

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

22 official languages

Bulgarian
Изменение на Регламент (ЕО) № 726/2004 за установяване на процедури на Общността за разрешаване и контрол на лекарствени продукти за хуманна и ветеринарна употреба и за създаване на Европейска агенция по лекарствата
Czech
Změna nařízení (ES) č. 726/2004, kterým se stanoví postupy Společenství pro registraci humánních a veterinárních léčivých přípravků a dozor nad nimi a kterým se zřizuje Evropská agentura pro léčivé přípravky
Danish
Ændring af forordning (EF) nr. 726/2004 om fastlæggelse af fællesskabsprocedurer for godkendelse og overvågning af human- og veterinærmedicinske lægemidler og om oprettelse af et europæisk lægemiddelagentur
German
Änderung der Verordnung (EG) Nr. 726/2004 zur Festlegung von Gemeinschaftsverfahren für die Genehmigung und Überwachung von Human- und Tierarzneimitteln und zur Errichtung einer Europäischen Arzneimittel-Agentur
Greek
Τροποποίηση του κανονισμού (ΕΚ) αριθ.º726/2004 για τη θέσπιση κοινοτικών διαδικασιών χορήγησης άδειας και εποπτείας όσον αφορά τα φάρμακα που προορίζονται για ανθρώπινη και για κτηνιατρική χρήση και για τη σύσταση Ευρωπαϊκού Οργανισμού Φαρμάκων
Spanish
Modificación del Reglamento (CE) n.º 726/2004 por el que se establecen procedimientos comunitarios para la autorización y el control de los medicamentos de uso humano y veterinario y por el que se crea la Agencia Europea de Medicamentos
Estonian
Määruse (EÜ) nr 726/2004 (milles sätestatakse ühenduse kord inim- ja veterinaarravimite lubade andmise ja järelevalve kohta ning millega asutatakse Euroopa ravimiamet) muutmine
Finnish
Ihmisille ja eläimille tarkoitettuja lääkkeitä koskevista yhteisön lupa- ja valvontamenettelyistä ja Euroopan lääkeviraston perustamisesta annetun asetuksen (EY) N:o 726/2004 muuttaminen
French
Modification du règlement (CE) nº 726/2004 établissant des procédures communautaires pour l’autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments
Croatian
Izmjena Uredbe (EZ) br. 726/2004 o utvrđivanju postupaka odobravanja primjene i postupaka nadzora nad primjenom lijekova koji se rabe u humanoj i veterinarskoj medicini, te uspostavi Europske agencije za lijekove
Hungarian
Az emberi, illetve állatgyógyászati felhasználásra szánt gyógyszerek engedélyezésére és felügyeletére vonatkozó közösségi eljárások meghatározásáról és az Európai Gyógyszerügynökség létrehozásáról szóló 726/2004/EK rendelet módosítása
Italian
Modifica del regolamento (CE) n. 726/2004 che istituisce procedure comunitarie per l'autorizzazione e la sorveglianza dei medicinali per uso umano e veterinario e che istituisce l'agenzia europea per i medicinali
Lithuanian
Reglamento (EB) Nr. 726/2004, nustatančio Bendrijos leidimų dėl žmonėms skirtų ir veterinarinių vaistų išdavimo ir priežiūros tvarką ir įsteigiančio Europos vaistų agentūrą, dalinis keitimas
Latvian
Grozījumu izdarīšana Regulā (EK) Nr. 726/2004, ar ko nosaka cilvēkiem paredzēto un veterināro zāļu reģistrēšanas un uzraudzības Kopienas procedūras un izveido Eiropas Zāļu aģentūru
Maltese
Emenda tar-Regolament (KE) Nru 726/2004 li jistabbilixxi proċeduri Komunitarji għall-awtorizzazzjoni u s-sorveljanza ta' prodotti mediċinali għall-użu mill-bniedem u veterinarju u li jistabbilixxi l-Aġenzija Ewropea għall-Mediċini
Dutch
Wijziging van Verordening (EG) nr. 726/2004 tot vaststelling van communautaire procedures voor het verlenen van vergunningen en het toezicht op geneesmiddelen voor menselijk en diergeneeskundig gebruik en tot oprichting van een Europees Geneesmiddelenbureau
Polish
Zmiana rozporządzenia (WE) nr 726/2004 ustanawiającego wspólnotowe procedury wydawania pozwoleń dla produktów leczniczych stosowanych u ludzi i do celów weterynaryjnych i nadzoru nad nimi oraz ustanawiające Europejską Agencję Leków
Portuguese
Alteração do Regulamento (CE) n.º 726/2004 que estabelece procedimentos comunitários de autorização e de fiscalização de medicamentos para uso humano e veterinário e que institui uma Agência Europeia de Medicamentos
Romanian
Modificarea Regulamentului (CE) nr. 726/2004 de stabilire a procedurilor comunitare privind autorizarea și supravegherea medicamentelor de uz uman și veterinar și de instituire a unei Agenții Europene pentru Medicamente
Slovak
Zmena nariadenia (ES) 726/2004, ktorým sa stanovujú postupy Spoločenstva pri povoľovaní liekov na humánne použitie a na veterinárne použitie a pri vykonávaní dozoru nad týmito liekmi a ktorým sa zriaďuje Európska agentúra pre lieky
Slovenian
Sprememba Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila
Swedish
Ändring av förordning (EG) nr 726/2004 om inrättande av gemenskapsförfaranden för godkännande av och tillsyn över humanläkemedel och veterinärmedicinska läkemedel samt om inrättande av en europeisk läkemedelsmyndighet

Records

Official bill 2014/0256(COD) from European Union at European Parliament. Dated 20 October 2014. Status: PLENARY_ADOPT_POSITION.

Timeline

20 October 2014
referral
Source: REFERRAL
20 October 2014
Introduced
Amendment to Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Source: COD
10 March 2016
plenary amend
Source: PLENARY_AMEND
10 March 2016
Vote results
Source: PLENARY_VOTE_RESULTS
25 October 2018
Position adopted
Source: PLENARY_ADOPT_POSITION
25 October 2018
Vote results
Source: PLENARY_VOTE_RESULTS
11 December 2018
signature
Source: SIGNATURE
7 January 2019
publication official journal
Source: PUBLICATION_OFFICIAL_JOURNAL

Votes

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Documents

258 official files

Registrace humánních a veterinárních léčivých přípravků a dozor nad nimi ***I

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Registrace humánních a veterinárních léčivých přípravků a dozor nad nimi ***I
TEXT_ADOPTED · CS · 17 October 2019
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Registrace humánních a veterinárních léčivých přípravků a dozor nad nimi ***I
TEXT_ADOPTED · CS · 17 October 2019
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Povoľovanie liekov na humánne použitie a na veterinárne použitie a vykonávanie dozoru nad týmito liekmi ***I
TEXT_ADOPTED · SK · 15 October 2019
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Povoľovanie liekov na humánne použitie a na veterinárne použitie a vykonávanie dozoru nad týmito liekmi ***I
TEXT_ADOPTED · SK · 15 October 2019
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Az állatgyógyászati felhasználásra szánt gyógyszerek engedélyezése és felügyelet ***I
TEXT_ADOPTED · HU · 15 October 2019
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Az állatgyógyászati felhasználásra szánt gyógyszerek engedélyezése és felügyelet ***I
TEXT_ADOPTED · HU · 15 October 2019
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Ihmisille ja eläimille tarkoitettuja lääkkeitä koskevat luvat ja valvonta ***I
TEXT_ADOPTED · FI · 15 October 2019
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Ihmisille ja eläimille tarkoitettuja lääkkeitä koskevat luvat ja valvonta ***I
TEXT_ADOPTED · FI · 15 October 2019
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Het verlenen van vergunningen voor en het toezicht op geneesmiddelen voor menselijk en diergeneeskundig gebruik ***I
TEXT_ADOPTED · NL · 14 October 2019
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Het verlenen van vergunningen voor en het toezicht op geneesmiddelen voor menselijk en diergeneeskundig gebruik ***I
TEXT_ADOPTED · NL · 14 October 2019
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Χορήγηση άδειας και εποπτείας όσον αφορά τα φάρμακα που προορίζονται για ανθρώπινη και κτηνιατρική χρήση ***I
TEXT_ADOPTED · EL · 14 October 2019
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Χορήγηση άδειας και εποπτείας όσον αφορά τα φάρμακα που προορίζονται για ανθρώπινη και κτηνιατρική χρήση ***I
TEXT_ADOPTED · EL · 14 October 2019
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Godkendelse og overvågning af human- og veterinærmedicinske lægemidler ***I
TEXT_ADOPTED · DA · 14 October 2019
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Godkendelse og overvågning af human- og veterinærmedicinske lægemidler ***I
TEXT_ADOPTED · DA · 14 October 2019
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Autorisation et surveillance des médicaments à usage humain et à usage vétérinaire ***I
TEXT_ADOPTED · FR · 14 October 2019
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Autorisation et surveillance des médicaments à usage humain et à usage vétérinaire ***I
TEXT_ADOPTED · FR · 14 October 2019
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Genehmigung und Überwachung von Human- und Tierarzneimitteln ***I
TEXT_ADOPTED · DE · 11 October 2019
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Genehmigung und Überwachung von Human- und Tierarzneimitteln ***I
TEXT_ADOPTED · DE · 11 October 2019
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Authorisation and supervision of medicinal products for human and veterinary use ***I
TEXT_ADOPTED · EN · 11 October 2019
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Authorisation and supervision of medicinal products for human and veterinary use ***I
TEXT_ADOPTED · EN · 11 October 2019
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Žmonėms skirtų ir veterinarinių vaistų išdavimas ir priežiūra ***I
TEXT_ADOPTED · LT · 11 October 2019
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Žmonėms skirtų ir veterinarinių vaistų išdavimas ir priežiūra ***I
TEXT_ADOPTED · LT · 11 October 2019
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Suite donnée au T8-0088/2016
ACT_FOLLOWUP · FR · 9 January 2019
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Follow up to T8-0088/2016
ACT_FOLLOWUP · EN · 9 January 2019
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Godkännande av och tillsyn över veterinärmedicinska läkemedel***I
TEXT_ADOPTED · SV · 11 January 2018
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Autorizarea și supravegherea medicamentelor de uz veterinar ***I
TEXT_ADOPTED · RO · 11 January 2018
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Pridobitev dovoljenja za promet in nadzor zdravil za veterinarsko uporabo ***I
TEXT_ADOPTED · SL · 11 January 2018
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Povoľovanie liekov na veterinárne použitie a vykonávanie dozoru nad nimi ***I
TEXT_ADOPTED · SK · 11 January 2018
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Autorização e fiscalização de medicamentos veterinários ***I
TEXT_ADOPTED · PT · 11 January 2018
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Wydawanie pozwoleń dla weterynaryjnych produktów leczniczych i nadzór nad nimi ***I
TEXT_ADOPTED · PL · 11 January 2018
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Verlenen van vergunningen en toezicht op geneesmiddelen voor diergeneeskundig gebruik ***I
TEXT_ADOPTED · NL · 11 January 2018
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Veterināro zāļu reģistrēšana un uzraudzība ***I
TEXT_ADOPTED · LV · 11 January 2018
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L-awtorizzazzjoni u s-sorveljanza ta' prodotti mediċinali veterinarji ***
TEXT_ADOPTED · MT · 11 January 2018
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Autorizzazione e sorveglianza dei medicinali veterinari ***I
TEXT_ADOPTED · IT · 11 January 2018
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Veterinarinių vaistų išdavimas ir priežiūra ***I
TEXT_ADOPTED · LT · 11 January 2018
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Az állatgyógyászati felhasználásra szánt gyógyszerek engedélyezése és felügyelete ***I
TEXT_ADOPTED · HU · 11 January 2018
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Odobravanje primjene i postupci nadzora nad primjenom lijekova koji se rabe u veterinarskoj medicini ***I
TEXT_ADOPTED · HR · 11 January 2018
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Autorisation et surveillance des médicaments vétérinaires ***I
TEXT_ADOPTED · FR · 11 January 2018
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Eläinlääkkeitä koskevat luvat ja niiden valvonta ***I
TEXT_ADOPTED · FI · 11 January 2018
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Veterinaarravimite lubade andmine ja järelevalve ***I
TEXT_ADOPTED · ET · 11 January 2018
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Autorización y control de los medicamentos de uso veterinario ***I
TEXT_ADOPTED · ES · 11 January 2018
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Χορήγηση άδειας και εποπτεία για τα φάρμακα που προορίζονται για ανθρώπινη και κτηνιατρική χρήση ***I
TEXT_ADOPTED · EL · 11 January 2018
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Authorisation and supervision of veterinary medicinal products ***I
TEXT_ADOPTED · EN · 11 January 2018
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Godkendelse og overvågning af veterinærmedicinske lægemidler ***I
TEXT_ADOPTED · DA · 11 January 2018
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Genehmigung und Überwachung von Tierarzneimitteln ***I
TEXT_ADOPTED · DE · 11 January 2018
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Registrace humánních a veterinárních léčivých přípravků a dozor nad nimi ***I
TEXT_ADOPTED · CS · 11 January 2018
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Разрешаване и контрол на ветеринарномедицински продукти ***I
TEXT_ADOPTED · BG · 11 January 2018
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Godkännande av och tillsyn över veterinärmedicinska läkemedel***I
TEXT_ADOPTED · SV · 14 December 2017
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Godkännande av och tillsyn över veterinärmedicinska läkemedel***I
TEXT_ADOPTED · SV · 14 December 2017
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Godkännande av och tillsyn över veterinärmedicinska läkemedel***I
TEXT_ADOPTED · SV · 14 December 2017
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Sources

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Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2014%2F0256(COD)
Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2014-0256
eu · 2014-0256 · source updated 7 January 2019