Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG (88862/EU XXIV.GP)

RAT: 12751/12 PUBLIC
19.07.2012
deutsch (Orginalsprache englisch)

EU-V: U32 Offizielles Ratsdokument

Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG

Gruppe: Gruppe "Arzneimittel und Medizinprodukte"

betrifft Sitzung am 24.07.2012

Erstellt am 19.07.2012 von: Beschäftigung, Sozialpolitik, Gesundheit und Lebensmittel

Eingelangt am 23.07.2012, U32 Übermittlung

 Einklappen
Datum EU-Datenbanknr. Dokument der EU-Vorlage Sprache Einstufung
19.07.2012 88690/EU XXIV.GP
englisch PUBLIC

EU-Vorlage: U32 Offizielles Ratsdokument

Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Eingelangt am 20.07.2012, U32 Übermittlung
19.07.2012 90251/EU XXIV.GP
deutsch PUBLIC

EU-Vorlage: U32 Offizielles Ratsdokument

ARBEITSUNTERLAGE DER KOMMISSIONSDIENSTSTELLEN ZUSAMMENFASSUNG DER FOLGENABSCHÄTZUNG ZUR ÜBERARBEITUNG DER RICHTLINIE ÜBER KLINISCHE PRÜFUNGEN (RICHTLINIE 2001/20/EG) Begleitunterlage zum Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG

Eingelangt am 04.09.2012, U32 Übermittlung
19.07.2012 88685/EU XXIV.GP
englisch PUBLIC

EU-Vorlage: U32 Offizielles Ratsdokument

COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT ON THE REVISION OF THE 'CLINICAL TRIALS DIRECTIVE' 2001/20/EC Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Eingelangt am 20.07.2012, U32 Übermittlung
19.07.2012 88686/EU XXIV.GP
englisch PUBLIC

EU-Vorlage: U32 Offizielles Ratsdokument

COMMISSION STAFF WORKING DOCUMENT Impact assessment report on the revision of the "Clinical Trials Directive" 2001/20/EC Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Eingelangt am 20.07.2012, U32 Übermittlung
19.07.2012 88687/EU XXIV.GP
englisch PUBLIC

EU-Vorlage: U32 Offizielles Ratsdokument

COMMISSION STAFF WORKING DOCUMENT Impact assessment report on the revision of the “Clinical Trials Directive” 2001/20/EC Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Eingelangt am 20.07.2012, U32 Übermittlung
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Datum Dok.Nr.
Art Betreff
12.07.2012 RAT: CM 3928/12 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Tuesday, 24 July 2012 (10h00) Venue: COUNCIL, JUSTIS LIPSIUS BUILDING Rue de la loi 175, 1048 BRUSSELS (87939/EU XXIV.GP)
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Interinstitutionelle Zahl
Link
2012/0192 COD Legislative Observatory
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Code Sachgebiet
PHARM 60 Pharmazie
SAN 176 Gesundheit
MI 508 Binnenmarkt
COMPET 513 Wettbewerbsfähigkeit (Binnenmarkt/Industrie)
CODEC 1946 Mitentscheidungsverfahren
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Thema
Binnenmarkt und Wettbewerb
Forschung und Innovation
Gesundheitswesen
Institutionelle Fragen
Verbraucher- und Lebensmittelsicherheit
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Datum Dok.Nr.
Art Betreff
19.10.2012 RAT: 14982/12 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from Portuguese Parliament (94900/EU XXIV.GP)
07.04.2014 RAT: 8245/14 EUST
Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG (erste Lesung) – Annahme des Gesetzgebungsakts (GA + E) (21215/EU XXV.GP)
 Aufklappen
Datum Dok.Nr.
Art Betreff
19.10.2012 RAT: 14960/12 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from Italian Senate (94901/EU XXIV.GP)
19.10.2012 RAT: 14986/12 EUNP
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC/2012/0192 (COD)/Cover note from Polish Sejm (95018/EU XXIV.GP)
22.02.2013 RAT: 5903/13 EUST
List of DS documents distributed to the Working Party on Pharmaceuticals and Medical Devices concerning clinical trials on medicinal products for human use in the second half of 2012 (106962/EU XXIV.GP)
10.06.2013 RAT: 10359/13 EUST
Employment, Social Policy, Health and Consumers Council meeting on 20 and 21 June 2013 Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Progress report (117169/EU XXIV.GP)
14.06.2013 RAT: 10452/13 EUST
Employment, Social Policy, Health and Consumers Council meeting on 20 and 21 June 2013 Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Progress report (118123/EU XXIV.GP)
16.07.2013 RAT: 12424/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - List of DS documents distributed during the first half of 2013 under the IE Presidency (121913/EU XXIV.GP)
20.09.2013 RAT: 13463/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (125357/EU XXIV.GP)
29.10.2013 RAT: 15245/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Preparation of the first informal trialogue (60/EU XXV.GP)
03.12.2013 RAT: 15720/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Preparation of the third informal trialogue (4753/EU XXV.GP)
27.11.2013 RAT: 16636/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Preparation of the third informal trialogue (4047/EU XXV.GP)
09.12.2013 RAT: 17474/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Preparation of the fourth informal trialogue (5832/EU XXV.GP)
17.12.2013 RAT: 17863/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Analysis of the final compromise text with a view to agreement (7183/EU XXV.GP)
17.12.2013 RAT: 17865/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Analysis of the final compromise text with a view to agreement (7301/EU XXV.GP)
20.12.2013 RAT: 17866/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (7823/EU XXV.GP)
09.01.2013 RAT: 18128/12 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (103160/EU XXIV.GP)
20.01.2014 RAT: 5395/14 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - List of DS documents distributed during the second half of 2013 under the LT Presidency (9394/EU XXV.GP)
22.02.2013 RAT: 6670/13 EUST
Opinion of the European Data Protection Supervisor on the Commission proposal for a Regulation on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (106961/EU XXIV.GP)
16.04.2013 RAT: 7816/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (111572/EU XXIV.GP)
09.12.2013 RAT: 17474/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Preparation of the fourth informal trialogue (5832/EU XXV.GP)
19.10.2012 RAT: 14960/12 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from Italian Senate (94901/EU XXIV.GP)
19.10.2012 RAT: 14982/12 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from Portuguese Parliament (94900/EU XXIV.GP)
16.04.2013 RAT: 7816/13 EUST
Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (111572/EU XXIV.GP)
 Aufklappen
Datum Dok.Nr.
Art Betreff
05.06.2013 RAT: CM 3073/13 EUTO
3247. Tagung des RATES DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz), Termin: 20.-21. Juni 2013 Uhrzeit: 09.30, 10.00 Ort: Konferenzzentrum – KIRCHBERG-Gebäude Place de l'Europe 4 1499 LUXEMBURG (116813/EU XXIV.GP)
12.07.2012 RAT: CM 3928/12 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Tuesday, 24 July 2012 (10h00) Venue: COUNCIL, JUSTIS LIPSIUS BUILDING Rue de la loi 175, 1048 BRUSSELS (87939/EU XXIV.GP)
26.07.2012 RAT: CM 4097/12 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Tuesday, 4 September 2012 (10h00) Venue: COUNCIL, JUSTUS LIPSIUS BUILDING Rue de la loi 175, 1048 BRUSSELS (89185/EU XXIV.GP)
24.09.2012 RAT: CM 4535/12 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Tuesday, 2 October 2012 (10h00) Venue: COUNCIL, JUSTUS LIPSIUS BUILDING Rue de la loi 175, 1048 BRUSSELS (92005/EU XXIV.GP)
24.10.2012 RAT: CM 5042/12 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Tuesday, 6 November 2012 (10h00) Venue: COUNCIL, LEX BUILDING Rue de la loi 145, 1048 BRUSSELS (95472/EU XXIV.GP)
17.01.2013 RAT: CM 1185/13 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Thursday, 31 January 2013 (14h30) (Afternoon only) Venue: COUNCIL, JUSTUS LIPSIUS BUILDING Rue de la loi 175, 1048 BRUSSELS (103769/EU XXIV.GP)
06.02.2013 RAT: CM 1470/13 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Wednesday, 13 February 2013 (10h00) Venue: COUNCIL, LEX BUILDING Rue de la loi 145, 1048 BRUSSELS (105323/EU XXIV.GP)
04.01.2012 RAT: CM 5916/12 EUTO
Working Party on Energy, 10 January 2012 (68538/EU XXIV.GP)
30.11.2012 RAT: CM 5640/12 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Tuesday, 11 December 2012 (09h45) Venue: COUNCIL, JUSTUS LIPSIUS BUILDING Rue de la loi 175, 1048 BRUSSELS (99791/EU XXIV.GP)
07.02.2014 RAT: CM 1577/14 EUTO
Jurists/Linguists Group Date: Monday 10 March 2014 (10h00) Venue: COUNCIL JUSTUS LIPSIUS BUILDING - Meeting room 20.7 Rue de la Loi 175, 1048 BRUSSELS (11724/EU XXV.GP)
05.06.2013 RAT: CM 3073/13 EUTO
3247. Tagung des RATES DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz), Termin: 20.-21. Juni 2013 Uhrzeit: 09.30, 10.00 Ort: Konferenzzentrum – KIRCHBERG-Gebäude Place de l'Europe 4 1499 LUXEMBURG (116813/EU XXIV.GP)
19.06.2013 RAT: 10889/13 EUTO
3247. Tagung des RATES DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) Termin: 20.-21. Juni 2013 Uhrzeit: 09.30, 10.30 Ort: Luxemburg (118577/EU XXIV.GP)
05.06.2013 RAT: CM 3073/13 EUTO
3247. Tagung des RATES DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz), Termin: 20.-21. Juni 2013 Uhrzeit: 09.30, 10.00 Ort: Konferenzzentrum – KIRCHBERG-Gebäude Place de l'Europe 4 1499 LUXEMBURG (116813/EU XXIV.GP)
19.06.2013 RAT: 10889/13 EUTO
3247. Tagung des RATES DER EUROPÄISCHEN UNION (Beschäftigung, Sozialpolitik, Gesundheit und Verbraucherschutz) Termin: 20.-21. Juni 2013 Uhrzeit: 09.30, 10.30 Ort: Luxemburg (118577/EU XXIV.GP)
10.06.2013 RAT: 10727/13 EUTO
2456. Tagung des AUSSCHUSSES DER STÄNDIGEN VERTRETER (1. Teil) Termin: 12./14. Juni 2013 Uhrzeit: 09.00 Ort: Brüssel (117342/EU XXIV.GP)
07.06.2013 RAT: CM 3215/13 EUTO
2456. Tagung des AUSSCHUSSES DER STÄNDIGEN VERTRETER (1. Teil) Termin: 12./14. Juni 2013 Uhrzeit: 09.00, 09:30 Ort: RAT JUSTUS-LIPSIUS-GEBÄUDE Rue de la Loi 175, 1048 BRÜSSEL (117133/EU XXIV.GP)
10.06.2013 RAT: 10727/13 EUTO
2456. Tagung des AUSSCHUSSES DER STÄNDIGEN VERTRETER (1. Teil) Termin: 12./14. Juni 2013 Uhrzeit: 09.00 Ort: Brüssel (117342/EU XXIV.GP)
Dok.Nr.
Links
COM: COM(2012) 369 EUR-Lex IPEX