Vorschlag für eine VERORDNUNG DES EUROPÄISCHEN PARLAMENTS UND DES RATES zur 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 (38214/EU XXV.GP)

RAT: 13240/14 PUBLIC
17.09.2014
deutsch (Orginalsprache englisch)

EU-V: U32 Offizielles Ratsdokument

Vorschlag für eine VERORDNUNG DES EUROPÄISCHEN PARLAMENTS UND DES RATES zur 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

Erstellt am 17.09.2014 von: Beschäftigung, Sozialpolitik, Gesundheit und Lebensmittel

Eingelangt am 17.09.2014, U32 Übermittlung

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Linkart Link
COM
COM(2014) 557
INT
2014/0256 (COD)
RMA
AGRILEG 186
RMA
CODEC 1839
RMA
MI 666
RMA
PHARM 69
RMA
VETER 86
ABL
ABl. L 136 vom 30.4.2004, S. 1
ABL
ABl. L 311 vom 28.11.2001, S. 1
ABL
ABl. L 55 vom 28.2.2011, S. 13
RIL
2001/82/EG
RIL
2001/83/EG
VER
182/2011
VER
726/2004
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Datum EU-Datenbanknr. Dokument der EU-Vorlage Sprache Einstufung
17.09.2014 38166/EU XXV.GP
englisch PUBLIC

EU-Vorlage: U32 Offizielles Ratsdokument

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending 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

Eingelangt am 17.09.2014, U32 Übermittlung
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Dok.Nr.
Betreff
COM: COM(2014) 557 Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates zur 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 (Text von Bedeutung für den EWR) (37447/EU XXV.GP)
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Interinstitutionelle Zahl
Link
2014/0256 COD Legislative Observatory
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Code Sachgebiet
PHARM 69 Pharmazie
VETER 86 Veterinärfragen
MI 666 Binnenmarkt
AGRILEG 186 Agrarpolitik: Harmonisierung der Rechtsvorschriften
CODEC 1839 Mitentscheidungsverfahren
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Thema
Binnenmarkt und Wettbewerb
Gesundheitswesen
Institutionelle Fragen
Landwirtschaft
Verbraucher- und Lebensmittelsicherheit
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Datum Dok.Nr.
Art Betreff
20.10.2014 RAT: CM 4633/14 EUCM
Consultation of the European Economic and Social Committee by the Council Consultation of the Committee of the Regions by the Council on a proposal for a Regulation of the European Parliament and of the Council amending 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 (42620/EU XXV.GP)
24.11.2014 RAT: 15987/14 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending 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 Opinion on the application of the Principles of Subsidiarity and Proportionality/COVER NOTE from Portuguese Parliament (Assembleia da Republica) (47872/EU XXV.GP)
28.11.2014 RAT: 16096/14 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending 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 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on veterinary medicinal products Opinion on the application of the Principles of Subsidiarity and Proportionality/COVER NOTE from Spanish congress (48086/EU XXV.GP)
11.12.2014 RAT: 16818/14 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending 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 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on veterinary medicinal products Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from Italian Senate (50378/EU XXV.GP)
28.11.2014 RAT: 16096/14 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending 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 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on veterinary medicinal products Opinion on the application of the Principles of Subsidiarity and Proportionality/COVER NOTE from Spanish congress (48086/EU XXV.GP)
11.12.2014 RAT: 16818/14 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending 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 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on veterinary medicinal products Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from Italian Senate (50378/EU XXV.GP)
16.11.2018 RAT: 13919/18 EUST
Entwurf einer Verordnung des Europäischen Parlaments und des Rates zur 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, Verordnung (EG) Nr. 1901/2006 über Kinderarzneimittel und Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel (erste Lesung) – Annahme des Gesetzgebungsakts (43381/EU XXVI.GP)
13.09.2016 RAT: 11487/16 EUST
Proposal for a regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (114932/EU XXV.GP)
14.12.2017 RAT: 15437/17 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (5849/EU XXVI.GP)
18.10.2017 RAT: 13222/17 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (158471/EU XXV.GP)
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Datum Dok.Nr.
Art Betreff
13.09.2016 RAT: 11487/16 EUST
Proposal for a regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (114932/EU XXV.GP)
13.10.2016 RAT: 12995/16 EUST
Proposal for a regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (118792/EU XXV.GP)
12.09.2017 RAT: 11371/17 EUST
Proposal for a regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (153930/EU XXV.GP)
18.10.2017 RAT: 13222/17 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (158471/EU XXV.GP)
07.11.2017 RAT: 13906/17 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (160988/EU XXV.GP)
24.11.2017 RAT: 14352/17 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (2583/EU XXVI.GP)
28.11.2016 RAT: 14448/16 EUST
Proposal for a regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (124358/EU XXV.GP)
14.12.2017 RAT: 15437/17 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (5849/EU XXVI.GP)
21.12.2017 RAT: 15911/17 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (6667/EU XXVI.GP)
05.01.2018 RAT: 15977/17 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (7051/EU XXVI.GP)
10.02.2018 RAT: 5923/18 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (10905/EU XXVI.GP)
27.02.2018 RAT: 6462/18 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency - Analysis of the final compromise text with a view to agreement (12896/EU XXVI.GP)
23.03.2018 RAT: 7259/18 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (16002/EU XXVI.GP)
08.06.2018 RAT: 9488/18 EUST
Proposal for a Regulation amending Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency - Confirmation of the final compromise text with a view to agreement (25361/EU XXVI.GP)
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Datum Dok.Nr.
Art Betreff
06.06.2018 RAT: CM 3034/18 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) ECCL, Luxemburg 21. und 22. Juni 2018 (9.30 Uhr, 9.30 Uhr) (25063/EU XXVI.GP)
16.07.2018 RAT: CM 3818/18 EUTO
Jurists/Linguists Group Date: 13 September 2018 Time: 10.00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (31049/EU XXVI.GP)
08.01.2016 RAT: CM 1065/16 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: 21 January 2016 Time: 10.00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (89438/EU XXV.GP)
29.09.2014 RAT: CM 4213/14 EUTO
Working Party of Veterinary Experts (Animal Health) Date: 9 October 2014 Time: 10.00 Venue: COUNCIL LEX BUILDING Rue de la Loi 145, 1048 BRUSSELS (39787/EU XXV.GP)
02.03.2016 RAT: CM 1776/16 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: 10 March 2016 Time: 10.00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (95260/EU XXV.GP)
06.04.2016 RAT: CM 2180/16 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: 20 April 2016 Time: 10.00 Venue: COUNCIL JUSTUS LIPSIUS BUILDING Rue de la Loi 175, 1048 BRUSSELS (98733/EU XXV.GP)
20.06.2018 RAT: 9866/18 EUTO
Rat der Europäischen Union (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz), 21. und 22. Juni 2018 (27421/EU XXVI.GP)
06.06.2018 RAT: CM 3034/18 EUTO
RAT DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) ECCL, Luxemburg 21. und 22. Juni 2018 (9.30 Uhr, 9.30 Uhr) (25063/EU XXVI.GP)
20.06.2018 RAT: 9866/18 EUTO
Rat der Europäischen Union (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz), 21. und 22. Juni 2018 (27421/EU XXVI.GP)
Dok.Nr.
Links
COM: COM(2014) 557 EUR-Lex IPEX