BETA

Procedure completed



2006/0207(COD) Medicinal products for paediatric use: implementing powers conferred on the Commission
RoleCommitteeRapporteurShadows
Lead ENVI GROSSETÊTE Françoise (PPE-DE)
Lead committee dossier: ENVI/6/41996
Legal Basis EC Treaty (after Amsterdam) EC 095

Activites

  • 2006/12/27 Final act published in Official Journal
  • 2006/12/20 Final act signed
  • 2006/12/20 End of procedure in Parliament
  • #2774
  • 2006/12/19 Council Meeting
  • 2006/12/19 Act adopted by Council after Parliament's 1st reading
  • 2006/12/14 Results of vote in Parliament
    • Results of vote in Parliament
    • T6-0592/2006 summary
  • 2006/11/22 Committee report tabled for plenary, 1st reading/single reading
  • 2006/11/21 Vote in committee, 1st reading/single reading
  • 2006/10/26 Committee referral announced in Parliament, 1st reading/single reading
  • 2006/10/24 Legislative proposal published
    • COM(2006)0640 summary
    • DG {'url': 'http://ec.europa.eu/enterprise/', 'title': 'Enterprise and Industry'}, VERHEUGEN Günter

Documents

History

(these mark the time of scraping, not the official date of the change)

activities
  • date: 2006-10-24T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2006/0640/COM_COM(2006)0640_EN.pdf title: COM(2006)0640 type: Legislative proposal published celexid: CELEX:52006PC0640:EN body: EC commission: DG: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry Commissioner: VERHEUGEN Günter type: Legislative proposal published
  • date: 2006-10-26T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: True committee: ENVI date: 2006-10-03T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: GROSSETÊTE Françoise
  • date: 2006-11-21T00:00:00 body: EP committees: body: EP responsible: True committee: ENVI date: 2006-10-03T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: GROSSETÊTE Françoise type: Vote in committee, 1st reading/single reading
  • date: 2006-11-22T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2006-396&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A6-0396/2006 body: EP committees: body: EP responsible: True committee: ENVI date: 2006-10-03T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: GROSSETÊTE Françoise type: Committee report tabled for plenary, 1st reading/single reading
  • date: 2006-12-14T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=12981&l=en type: Results of vote in Parliament title: Results of vote in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2006-592 type: Decision by Parliament, 1st reading/single reading title: T6-0592/2006 body: EP type: Results of vote in Parliament
  • date: 2006-12-19T00:00:00 body: CSL type: Council Meeting council: Agriculture and Fisheries meeting_id: 2774
  • date: 2006-12-19T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading
  • date: 2006-12-20T00:00:00 body: CSL type: Final act signed
  • date: 2006-12-20T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2006-12-27T00:00:00 type: Final act published in Official Journal docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32006R1902 title: Regulation 2006/1902 url: http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:378:SOM:EN:HTML title: OJ L 378 27.12.2006, p. 0020
commission
  • body: EC dg: Internal Market, Industry, Entrepreneurship and SMEs commissioner: VERHEUGEN Günter
committees/0
type
Responsible Committee
body
EP
associated
False
committee_full
Environment, Public Health and Food Safety
committee
ENVI
date
2006-10-03T00:00:00
rapporteur
name: GROSSETÊTE Françoise group: European People's Party (Christian Democrats) and European Democrats abbr: PPE-DE
committees/0
body
EP
responsible
True
committee
ENVI
date
2006-10-03T00:00:00
committee_full
Environment, Public Health and Food Safety
rapporteur
group: PPE-DE name: GROSSETÊTE Françoise
council
  • body: CSL type: Council Meeting council: Agriculture and Fisheries meeting_id: 2774 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=2774*&MEET_DATE=19/12/2006 date: 2006-12-19T00:00:00
docs
  • date: 2006-10-26T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE380.764 title: PE380.764 type: Committee draft report body: EP
  • date: 2006-11-22T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2006-396&language=EN title: A6-0396/2006 type: Committee report tabled for plenary, 1st reading/single reading body: EP
  • date: 2006-12-13T00:00:00 docs: url: https://dm.eesc.europa.eu/EESCDocumentSearch/Pages/redresults.aspx?k=(documenttype:AC)(documentnumber:1568)(documentyear:2006)(documentlanguage:EN) title: CES1568/2006 type: Economic and Social Committee: opinion, report body: ESC
  • date: 2006-12-20T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F06&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 03677/1/2006 type: Draft final act body: CSL
  • date: 2007-01-24T00:00:00 docs: url: /oeil/spdoc.do?i=12981&j=0&l=en title: SP(2007)0303 type: Commission response to text adopted in plenary
events
  • date: 2006-10-24T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2006/0640/COM_COM(2006)0640_EN.pdf title: COM(2006)0640 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2006&nu_doc=640 title: EUR-Lex summary: PURPOSE: to amend a 2006 Regulation of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation 1768/92/EEC, Directive 2001/20/EC, Directive 2001/83/EC and Regulation 726/2004/EC. PROPOSED ACT: Regulation of the European Parliament and of the Council. CONTENT: Decision 2006/512/EC introduced a new type of procedure for the exercise of implementing powers, the regulatory procedure with scrutiny (see CNS/2002/0298 ). It is now necessary to apply the regulatory procedure with scrutiny for measures of general scope designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements. The 2006 Regulation makes provision for implementing powers for the Commission through the regulatory procedure: – in Article 20(2), with a view to further defining the grounds for granting a deferral, and – in Article 49(3), with regard to the maximum amounts as well as the conditions and methods for collection of financial penalties. Consequently, it is necessary to amend this Regulation in order to make provision for the adoption of these two implementing measures by the new regulatory procedure with scrutiny, as they are intended to supplement the Regulation by the addition of new non-essential elements.
  • date: 2006-10-26T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2006-11-21T00:00:00 type: Vote in committee, 1st reading/single reading body: EP summary: The committee adopted the report by Françoise GROSSETÊTE (EPP-ED, FR) approving unamended - under the 1st reading of the codecision procedure - the proposed regulation amending the new regulation on medicinal products for paediatric use. The proposal was aimed at introducing into the regulation the new regulatory procedure with scrutiny that is now applicable for the exercise of implementing powers.
  • date: 2006-11-22T00:00:00 type: Committee report tabled for plenary, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2006-396&language=EN title: A6-0396/2006
  • date: 2006-12-14T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=12981&l=en title: Results of vote in Parliament
  • date: 2006-12-14T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2006-592 title: T6-0592/2006 summary: The European Parliament adopted a resolution drafted by Françoise GROSSETÊTE (EPP-ED, FR) regarding the proposal for amending the regulation on paediatric medicinal products. An agreement was concluded between the institutions giving rise to the quick adoption of this proposal. The plenary adopted three amendments adapting the new regulation to the new rules on comitology regarding the regulatory procedure with scrutiny.
  • date: 2006-12-19T00:00:00 type: Act adopted by Council after Parliament's 1st reading body: EP/CSL
  • date: 2006-12-20T00:00:00 type: Final act signed body: CSL
  • date: 2006-12-20T00:00:00 type: End of procedure in Parliament body: EP
  • date: 2006-12-27T00:00:00 type: Final act published in Official Journal summary: PURPOSE: to amend Regulation (EC) No 1901/2006 on medicinal products for paediatric use so as to align procedures for implementing measures with new rules on comitology (regulatory procedure with scrutiny). LEGISLATIVE ACT: Regulation (EC) No 1902/2006 of the European Parliament and of the Council amending Regulation 1901/2006 on medicinal products for paediatric use. CONTENT: this amending Regulation provides that the measures necessary for the implementation of Regulation (EC) No 1901/2006 should be adopted in accordance with Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission. In particular, the Commission is empowered to define further the grounds for granting a deferral for the initiation or completion of some or all of the measures in the paediatric investigation plan and to specify the maximum amounts as well as the conditions and methods for collection of the financial penalties for infringement of the provisions of Regulation (EC) No 1901/2006 or the implementing measures adopted pursuant to it. (Please see COD/2004/0217.) Since these measures are of general scope and are designed to supplement Regulation (EC) No 1901/2006 by the addition of new non-essential elements, these measures will be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. ENTRY INTO FORCE : 26/01/2007. docs: title: Regulation 2006/1902 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32006R1902 title: OJ L 378 27.12.2006, p. 0020 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2006:378:TOC
other
  • body: EC dg: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry commissioner: VERHEUGEN Günter
procedure/dossier_of_the_committee
Old
ENVI/6/41996
New
  • ENVI/6/41996
procedure/final/url
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32006R1902
New
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32006R1902
procedure/instrument
Old
Regulation
New
  • Regulation
  • Amending Regulation (EC) No 1901/2006 2004/0217(COD)
procedure/subject
Old
  • 4.20.04 Pharmaceutical products and industry
New
4.20.04
Pharmaceutical products and industry
procedure/summary
  • Amending Regulation (EC) No 1901/2006
activities/0/docs/0/url
Old
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2006/0640/COM_COM(2006)0640_EN.pdf
New
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2006/0640/COM_COM(2006)0640_EN.pdf
links/European Commission/title
Old
PreLex
New
EUR-Lex
activities
  • date: 2006-10-24T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2006/0640/COM_COM(2006)0640_EN.pdf celexid: CELEX:52006PC0640:EN type: Legislative proposal published title: COM(2006)0640 type: Legislative proposal published body: EC commission: DG: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry Commissioner: VERHEUGEN Günter
  • date: 2006-10-26T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: True committee: ENVI date: 2006-10-03T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: GROSSETÊTE Françoise
  • date: 2006-11-21T00:00:00 body: EP committees: body: EP responsible: True committee: ENVI date: 2006-10-03T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: GROSSETÊTE Françoise type: Vote in committee, 1st reading/single reading
  • date: 2006-11-22T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2006-396&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A6-0396/2006 body: EP committees: body: EP responsible: True committee: ENVI date: 2006-10-03T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: GROSSETÊTE Françoise type: Committee report tabled for plenary, 1st reading/single reading
  • date: 2006-12-14T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=12981&l=en type: Results of vote in Parliament title: Results of vote in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2006-592 type: Decision by Parliament, 1st reading/single reading title: T6-0592/2006 body: EP type: Results of vote in Parliament
  • date: 2006-12-19T00:00:00 body: CSL type: Council Meeting council: Agriculture and Fisheries meeting_id: 2774
  • date: 2006-12-19T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading
  • date: 2006-12-20T00:00:00 body: CSL type: Final act signed
  • date: 2006-12-20T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2006-12-27T00:00:00 type: Final act published in Official Journal docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32006R1902 title: Regulation 2006/1902 url: http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:378:SOM:EN:HTML title: OJ L 378 27.12.2006, p. 0020
committees
  • body: EP responsible: True committee: ENVI date: 2006-10-03T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: GROSSETÊTE Françoise
links
National parliaments
European Commission
other
  • body: EC dg: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry commissioner: VERHEUGEN Günter
procedure
dossier_of_the_committee
ENVI/6/41996
reference
2006/0207(COD)
instrument
Regulation
legal_basis
EC Treaty (after Amsterdam) EC 095
stage_reached
Procedure completed
summary
Amending Regulation (EC) No 1901/2006
subtype
Legislation
title
Medicinal products for paediatric use: implementing powers conferred on the Commission
type
COD - Ordinary legislative procedure (ex-codecision procedure)
final
subject
4.20.04 Pharmaceutical products and industry