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2008/0001(COD)

Colouring matters for medicinal products (repeal. Directive 78/25/EEC, adaptation to the regulatory procedure with scrutiny). Recast

Procedure completed

2008/0001(COD) Colouring matters for medicinal products (repeal. Directive 78/25/EEC, adaptation to the regulatory procedure with scrutiny). Recast
RoleCommitteeRapporteurShadows
Opinion ENVI ULMER Thomas (PPE-DE)
Lead JURI SZÁJER József (PPE-DE)
Lead committee dossier: JURI/6/58182
Legal Basis EC Treaty (after Amsterdam) EC 095
Subjects
Links

Activites

  • 2009/04/30 Final act published in Official Journal
  • 2009/04/23 Final act signed
  • 2009/04/22 End of procedure in Parliament
  • 2009/03/23 Act adopted by Council after Parliament's 1st reading
  • #2934
  • 2009/03/23 Council Meeting
  • 2008/09/23 Text adopted by Parliament, 1st reading/single reading
    • T6-0431/2008 summary
    • Results of vote in Parliament
  • 2008/09/23 Commission response to text adopted in plenary
  • 2008/07/01 Committee report tabled for plenary, 1st reading/single reading
  • 2008/06/26 Vote in committee, 1st reading/single reading
  • 2008/06/06 Committee draft report
  • 2008/02/19 Committee referral announced in Parliament, 1st reading/single reading
  • 2008/02/13 Economic and Social Committee: opinion, report
  • 2008/01/11 Legislative proposal
    • COM(2008)0001 summary
    • DG Legal Service, BARROSO José Manuel

Documents

Votes

Report: Szájer (A6-0280/2008) - resolution

2008/09/23
Position Total ALDE GUE/NGL IND/DEM NI PPE-DE PSE UEN Verts/ALE correctional
For 638 86 39 5 11 250 169 38 40 0
Against 16 0 0 10 6 0 0 0 0 0
Abstain 16 0 0 4 8 2 0 1 1 0

History

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

2012-02-09
activities added
  • date
    2008-01-11
    docs
    • url
      http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2008&nu_doc=0001
      text
      • PURPOSE: recast of the Directive 78/25/EEC on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products.

        PROPOSED ACT: Directive of the European Parliament and of the Council.

        CONTENT: the codification of Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products has been initiated by the Commission. The new Directive was to have superseded the various acts incorporated in it.

        In the meantime, Council Decision 1999/468/EC which lays down the procedures for the exercise of implementing powers conferred on the Commission (comitology) has been amended by Decision 2006/512/EC, which introduced a regulatory procedure with scrutiny for measures of general scope designed to amend non-essential elements of a basic instrument adopted in accordance with the codecision procedure.

        In accordance with the joint statement of the European Parliament, the Council and the Commission on Decision 2006/512/EC, for this new procedure to be applicable to instruments adopted in accordance with the codecision procedure, those instruments must be adjusted in accordance with the applicable procedures.

        It is therefore appropriate to transform the codification of Directive 78/25/EEC into a recast in order to incorporate the amendments necessary for the adjustment to the regulatory procedure with scrutiny.

      celexid
      CELEX:52008PC0001:EN
      type
      Legislative proposal published
      title
      COM(2008)0001
    body
    EC
    commission
    • DG
      Legal Service
      Commissioner
      BARROSO José Manuel
    type
    Legislative proposal
  • date
    2008-02-13
    docs
    • url
      http://eescopinions.eesc.europa.eu/eescopiniondocument.aspx?language=EN&docnr=0266&year=2008
      title
      CES0266/2008
      type
      Economic and Social Committee: opinion, report
      celexid
      CELEX:52008AE0266:EN
    body
    ESOC
    type
    Economic and Social Committee: opinion, report
  • date
    2008-02-19
    body
    EP
    type
    Committee referral announced in Parliament, 1st reading/single reading
    committees
  • date
    2008-06-06
    docs
    • url
      http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE407.752
      type
      Committee draft report
      title
      PE407.752
    body
    EP
    type
    Committee draft report
  • date
    2008-06-26
    text
    • The Committee on Legal Affairs adopted a report drafted by József SZAJER (EPP-ED, HU) and approved the proposal for a directive of the European Parliament and of the Council on the colouring matters which may be added to medicinal products (recast). The proposal was approved as adapted to the recommendations of the Consultative Working Party of the Legal Services of the European Parliament, the Council and the Commission.

    body
    EP
    committees
    type
    Vote in committee, 1st reading/single reading
  • date
    2008-07-01
    docs
    • url
      http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2008-0280&language=EN
      type
      Committee report tabled for plenary, 1st reading/single reading
      title
      A6-0280/2008
    body
    EP
    committees
    type
    Committee report tabled for plenary, 1st reading/single reading
  • date
    2008-09-23
    docs
    body
    EP
    type
    Text adopted by Parliament, 1st reading/single reading
  • date
    2008-09-23
    docs
    • url
      http://www.europarl.europa.eu/oeil/spdoc.do?i=15321&j=0&l=en
      type
      Commission response to text adopted in plenary
      title
      SP(2008)6073
    body
    EC
    commission
    • DG
      Legal Service
      Commissioner
      BARROSO José Manuel
    type
    Commission response to text adopted in plenary
  • date
    2009-03-23
    body
    type
    Act adopted by Council after Parliament's 1st reading
  • date
    2009-03-23
    body
    CSL
    type
    Council Meeting
    council
    Agriculture and Fisheries
    meeting_id
    2934
  • date
    2009-04-22
    body
    EP
    type
    End of procedure in Parliament
  • date
    2009-04-23
    body
    type
    Final act signed
  • date
    2009-04-30
    text
    • PURPOSE: to recast Directive 78/25/EEC on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products.

      LEGISLATIVE ACT: Directive 2009/35/EC of the European Parliament and of the Council on the colouring matters which may be added to medicinal products (recast).

      CONTENT: having reached agreement with the Parliament at first reading, the Council recasts and adapts Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products has been initiated by the Commission. The new Directive was to have superseded the various acts incorporated in it.

      In the meantime, Council Decision 1999/468/EC which lays down the procedures for the exercise of implementing powers conferred on the Commission (comitology) has been amended by Decision 2006/512/EC, which introduced a regulatory procedure with scrutiny for measures of general scope designed to amend non-essential elements of a basic instrument adopted in accordance with the codecision procedure.

      Consequently, the codification of Directive 78/25/EEC has been transformed into a recast in order to incorporate the amendments necessary for the adjustment to the regulatory procedure with scrutiny.

      The new Directive empowers the Commission to amend the limited period of use of medicinal products following the regulatory procedure with scrutiny.

      ENTRY INTO FORCE: 20/05/2009.

    type
    Final act published in Official Journal
    docs
committees added
  • body
    EP
    responsible
    False
    committee
    ENVI
    date
    2008-03-13
    committee_full
    Environment, Public Health and Food Safety
    rapporteur
    • group
      PPE-DE
      name
      ULMER Thomas
  • body
    EP
    responsible
    True
    committee
    JURI
    date
    2007-12-19
    committee_full
    Legal Affairs
    rapporteur
    • group
      PPE-DE
      name
      SZÁJER József
links added
National parliaments
European Commission
other added
  • body
    EC
    dg
    Legal Service
    commissioner
    BARROSO José Manuel
procedure added
dossier_of_the_committee
JURI/6/58182
reference
2008/0001(COD)
subtype
Recast
legal_basis
  • EC Treaty (after Amsterdam) EC 095
stage_reached
Procedure completed
instrument
Directive
title
Colouring matters for medicinal products (repeal. Directive 78/25/EEC, adaptation to the regulatory procedure with scrutiny). Recast
type
COD - Ordinary legislative procedure (ex-codecision)
final
subject