Vorschlag für eine VERORDNUNG DES EUROPÄISCHEN PARLAMENTS UND DES RATES über die Gebühren, die der Europäischen Arzneimittelagentur für die Durchführung von Pharmakovigilanz-Tätigkeiten in Bezug auf Humanarzneimittel zu entrichten sind (Text von Bedeutung für den EWR) (120386/EU XXIV.GP)

RAT: 11862/13 PUBLIC
03.07.2013
deutsch (Orginalsprache englisch)

EU-V: U32 Offizielles Ratsdokument

Vorschlag für eine VERORDNUNG DES EUROPÄISCHEN PARLAMENTS UND DES RATES über die Gebühren, die der Europäischen Arzneimittelagentur für die Durchführung von Pharmakovigilanz-Tätigkeiten in Bezug auf Humanarzneimittel zu entrichten sind (Text von Bedeutung für den EWR)

Erstellt am 03.07.2013 von: Beschäftigung, Sozialpolitik, Gesundheit und Lebensmittel

Eingelangt am 04.07.2013, U32 Übermittlung

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Datum EU-Datenbanknr. Dokument der EU-Vorlage Sprache Einstufung
03.07.2013 120283/EU XXIV.GP
englisch PUBLIC

EU-Vorlage: U32 Offizielles Ratsdokument

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (Text with EEA relevance)

Eingelangt am 03.07.2013, U32 Übermittlung
03.07.2013 120382/EU XXIV.GP
deutsch PUBLIC

EU-Vorlage: U32 Offizielles Ratsdokument

ARBEITSUNTERLAGE DER KOMMISSIONSDIENSTSTELLEN ZUSAMMENFASSUNG DER FOLGENABSCHÄTZUNG Begleitunterlage zum Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über die Gebühren, die der Europäischen Arzneimittelagentur (EMA) für die Durchführung von Pharmakovigilanz-Tätigkeiten in Bezug auf Humanarzneimittel zu entrichten sind

Eingelangt am 04.07.2013, U32 Übermittlung
03.07.2013 120288/EU XXIV.GP
englisch PUBLIC

EU-Vorlage: U32 Offizielles Ratsdokument

COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on the fees payable to the European Medicines Agency (EMA) for the conduct of pharmacovigilance activities in respect of medicinal products for human use

Eingelangt am 03.07.2013, U32 Übermittlung
03.07.2013 120287/EU XXIV.GP
englisch PUBLIC

EU-Vorlage: U32 Offizielles Ratsdokument

COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying document to the Proposal for a Regulation of the European Parliament and of the Council on the fees payable to the European Medicines Agency (EMA) for the conduct of pharmacovigilance activities in respect of medicinal products for human use

Eingelangt am 03.07.2013, U32 Übermittlung
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Interinstitutionelle Zahl
Link
2013/0222 COD Legislative Observatory
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Code Sachgebiet
PHARM 38 Pharmazie
SAN 250 Gesundheit
MI 603 Binnenmarkt
COMPET 538 Wettbewerbsfähigkeit (Binnenmarkt/Industrie)
CODEC 1668 Mitentscheidungsverfahren
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Thema
Binnenmarkt und Wettbewerb
Gesundheitswesen
Institutionelle Fragen
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Datum Dok.Nr.
Art Betreff
09.07.2013 RAT: CM 3712/13 EUCM
Consultation du Comité économique et social européen, par le Conseil, Consultation du Comité des régions, par le Conseil sur une proposition de règlement du Parlement européen et du Conseil relatif aux redevances dues à l’Agence européenne des médicaments pour la conduite d’activités de pharmacovigilance concernant des médicaments à usage humain [réf. 2013/0222 (COD) - COM(2013) 472 final - doc. 11862/13] (120870/EU XXIV.GP)
16.08.2013 RAT: 12720/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (123337/EU XXIV.GP)
28.04.2014 RAT: 8795/14 EUST
Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über die Gebühren, die der Europäischen Arzneimittelagentur für die Durchführung von Pharmakovigilanz-Tätigkeiten in Bezug auf Humanarzneimittel zu entrichten sind (Text von Bedeutung für den EWR) (erste Lesung) - Annahme des Gesetzgebungsakts (GA + E) (23431/EU XXV.GP)
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Datum Dok.Nr.
Art Betreff
05.09.2013 RAT: 13299/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use - Opinion on the application of the Principles of Subsidiarity and Proportionality/COVER NOTE from Italian Senate (123905/EU XXIV.GP)
09.10.2013 RAT: 14117/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use - Reasoned opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from Spanish Parliament (127335/EU XXIV.GP)
09.10.2013 RAT: 14129/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use - Reasoned opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from Hellenic Parliament (127313/EU XXIV.GP)
11.10.2013 RAT: 14728/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (First reading) (127786/EU XXIV.GP)
13.10.2013 RAT: 15719/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (First reading) (1721/EU XXV.GP)
10.01.2014 RAT: 5036/14 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (First reading) (8559/EU XXV.GP)
17.07.2013 RAT: 5396/14 EUST
Proposal for a Regulation of the European Parliament and of the Council on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use - List of DS documents distributed during the second half of 2013 under the LT Presidency (9239/EU XXV.GP)
22.11.2013 RAT: 16728/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (First reading) (3364/EU XXV.GP)
11.12.2013 RAT: 17463/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (First reading) (6155/EU XXV.GP)
23.12.2013 RAT: 18166/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (First reading) (7931/EU XXV.GP)
05.02.2014 RAT: 5796/14 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (First reading) (Legislative deliberation) - Preparation of the informal trialogue (11261/EU XXV.GP)
17.02.2014 RAT: 6505/14 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (First reading) (Legislative deliberation) - Analysis of the final text with a view to an agreement (12581/EU XXV.GP)
05.09.2013 RAT: 13299/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use - Opinion on the application of the Principles of Subsidiarity and Proportionality/COVER NOTE from Italian Senate (123905/EU XXIV.GP)
09.10.2013 RAT: 14117/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use - Reasoned opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from Spanish Parliament (127335/EU XXIV.GP)
09.10.2013 RAT: 14129/13 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use - Reasoned opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from Hellenic Parliament (127313/EU XXIV.GP)
16.01.2014 RAT: 5322/14 EUST
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (First reading) (Legislative deliberation) - Preparation of the informal trialogue (9041/EU XXV.GP)
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Datum Dok.Nr.
Art Betreff
04.07.2013 RAT: CM 3637/13 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Friday, 19 July 2013 (10h00, morning only) Venue: COUNCIL, Justus Lipsius Building Rue de la loi 175, 1048 BRUSSELS (120374/EU XXIV.GP)
25.07.2013 RAT: CM 3923/13 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Monday, 2 September 2013 (10h00) Venue: COUNCIL, Justus Lipsius Building Rue de la loi 175, 1048 BRUSSELS (122633/EU XXIV.GP)
09.09.2013 RAT: CM 4171/13 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Wednesday, 25 September 2013 (14h30) Venue: COUNCIL, Justus Lipsius Building Rue de la loi 175, 1048 BRUSSELS (124110/EU XXIV.GP)
30.09.2013 RAT: CM 4531/13 EUTO
Working Party on Pharmaceuticals and Medical Devices Date: Monday, 7 October 2013 (10h00) Venue: COUNCIL, Justius Lipsius Building Rue de la loi 174, 1048 BRUSSELS (126280/EU XXIV.GP)
10.03.2014 RAT: CM 1995/14 EUTO
Jurists/Linguists Group Date: Tuesday 25 March 2014 (10h00) Venue: COUNCIL JUSTUS LIPSIUS building - Meeting room 20.8 Rue de la Loi 175, 1048 BRUSSELS (15564/EU XXV.GP)
Dok.Nr.
Links
COM: COM(2013) 472 EUR-Lex IPEX