BETA


2006/0295(COD) Community code relating to medicinal products for human use: implementing powers of the Commission

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI GROSSETÊTE Françoise (icon: PPE-DE PPE-DE)
Lead committee dossier:
Legal Basis:
EC Treaty (after Amsterdam) EC 095

Events

2008/03/20
   Final act published in Official Journal
Details

PURPOSE: to amend Directive 2001/83/EC on the Community code relating to medicinal products for human use, by introducing a reference to the new regulatory procedure with scrutiny (comitology).

LEGISLATIVE ACT: Directive 2008/29/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission.

CONTENT: to recall, Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission has been amended by Council Decision 2006/512/EC ( CNS/2002/0298 ).

The amended Decision introduces a new regulatory procedure with scrutiny to be used for measures of general scope which seek to amend non-essential elements of a basic instrument, adopted under co-decision. This may include deleting some of those elements or supplementing the instrument, by the addition of new non-essential elements.

This procedure allows the legislator to oppose the adoption of "quasi-legislative" measures implementing a codecision-based instrument in cases where:

the draft may exceed the implementing powers provided for in the basic instrument; the draft is incompatible with the aim or the content of that instrument; or the draft fails to respect the principles of subsidiarity or proportionality.

In a joint statement, the three institutions agreed on a list of 26 basic instruments already in force to be adjusted without delay in accordance with the new regulatory procedure with scrutiny (see ACI/2006/2152 ). Each case has been assessed on the nature of the implementing powers conferred on the Commission and the specificity of each sector.

The purpose of this act, therefore, is to amend EU legislation relating to medicinal products for human use, by introducing the new regulatory procedure with scrutiny .

ENTRY INTO FORCE: 21 March 2008.

2008/03/11
   CSL - Draft final act
Documents
2008/03/11
   CSL - Final act signed
2008/03/11
   EP - End of procedure in Parliament
2008/03/03
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2008/03/03
   CSL - Council Meeting
2007/12/18
   EC - Commission response to text adopted in plenary
Documents
2007/11/29
   EP - Results of vote in Parliament
2007/11/29
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted a resolution drafted by Francoise GROSSETETE (EPP-ED, FR) on the proposal amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission. It made some amendments to the Commission’s proposal:

- Article 107 was amended to read that the decision on the final measures concerning the product shall be adopted in accordance with the procedure referred to in Article 121(3). Article 107 concerns a particular medicinal product for which a Member State has considered taking regulatory action on pharmacovigilance grounds;

- the rules of procedure of the Standing Committee shall be made public.

Documents
2007/07/05
   EP - Committee report tabled for plenary, 1st reading/single reading
Documents
2007/07/05
   EP - Committee report tabled for plenary, 1st reading
Documents
2007/06/26
   EP - Vote in committee, 1st reading
Details

The Committee on the Environment, Public Health and Food Safety adopted by a large majority the report drafted by Francoise GROSSETETE (EPP-ED, FR) and made three amendments to the Commission’s proposal:

- a new clause was inserted stating that a list of herbal substances, and preparations and combinations of such substances for use in traditional herbal medicinal products, designed to amend non-essential elements of the Directive by supplementing it, must be established in accordance with the regulatory procedure with scrutiny. This list must contain, with regard to each herbal substance, the indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product;

- the final measures designed to amend non-essential elements of the Directive by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny;

- whilst the Commission had proposed the deletion of Article 121(4), the Committee felt that this paragraph should remain, since the comitology committee should be obliged to publish its internal rules.

2007/06/14
   EP - Amendments tabled in committee
Documents
2007/06/05
   EP - Committee draft report
Documents
2007/02/27
   EP - GROSSETÊTE Françoise (PPE-DE) appointed as rapporteur in ENVI
2007/01/17
   EP - Committee referral announced in Parliament, 1st reading
2006/12/22
   EC - Legislative proposal
Details

PURPOSE: to amend Directive 2001/83/EC on the Community code relating to medicinal products for human use by introducing a reference to the new regulatory procedure with scrutiny (comitology).

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

CONTENT: Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission has been amended by Council Decision 2006/512/EC ( CNS/2002/0298 ).

The amended Decision introduces a new regulatory procedure with scrutiny to be used for measures of general scope which seek to amend non-essential elements of a basic instrument, adopted under co-decision, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

This procedure allows the legislator to oppose the adoption of "quasi-legislative" measures implementing a codecision-based instrument when it considers that the draft exceeds the implementing powers provided for in the basic instrument, or that the draft is incompatible with the aim or the content of that instrument or fails to respect the principles of subsidiarity or proportionality.

In a joint statement, the three institutions agreed on a list of 26 basic instruments already in force to be adjusted without delay in accordance with the new regulatory procedure with scrutiny (see ACI/2006/2152 ). Each case has been assessed on its own merits, notably in view of the nature of the implementing powers conferred on the Commission and the specificity of each sector.

Lastly, in accordance with the abovementioned statement, the Commission is proposing to repeal any provisions of these instruments that provide for a time-limit on the delegation of implementing powers to the Commission.

2006/12/21
   EC - Legislative proposal published
Details

PURPOSE: to amend Directive 2001/83/EC on the Community code relating to medicinal products for human use by introducing a reference to the new regulatory procedure with scrutiny (comitology).

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

CONTENT: Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission has been amended by Council Decision 2006/512/EC ( CNS/2002/0298 ).

The amended Decision introduces a new regulatory procedure with scrutiny to be used for measures of general scope which seek to amend non-essential elements of a basic instrument, adopted under co-decision, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

This procedure allows the legislator to oppose the adoption of "quasi-legislative" measures implementing a codecision-based instrument when it considers that the draft exceeds the implementing powers provided for in the basic instrument, or that the draft is incompatible with the aim or the content of that instrument or fails to respect the principles of subsidiarity or proportionality.

In a joint statement, the three institutions agreed on a list of 26 basic instruments already in force to be adjusted without delay in accordance with the new regulatory procedure with scrutiny (see ACI/2006/2152 ). Each case has been assessed on its own merits, notably in view of the nature of the implementing powers conferred on the Commission and the specificity of each sector.

Lastly, in accordance with the abovementioned statement, the Commission is proposing to repeal any provisions of these instruments that provide for a time-limit on the delegation of implementing powers to the Commission.

Documents

History

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

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Legislative proposal published
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docs
summary
links/National parliaments/url
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http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2006&number=0295&appLng=EN
New
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docs/0/docs/0/url
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http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE390.464
New
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docs/1/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE390.712
New
https://www.europarl.europa.eu/doceo/document/EN&reference=PE390.712
docs/2/docs/0/url
Old
http://www.europarl.europa.eu/doceo/document/A-6-2007-0277_EN.html
New
https://www.europarl.europa.eu/doceo/document/A-6-2007-0277_EN.html
docs/3/docs/0/url
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Committee referral announced in Parliament, 1st reading/single reading
New
Committee referral announced in Parliament, 1st reading
events/2/type
Old
Vote in committee, 1st reading/single reading
New
Vote in committee, 1st reading
events/3
date
2007-07-05T00:00:00
type
Committee report tabled for plenary, 1st reading
body
EP
docs
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events/3
date
2007-07-05T00:00:00
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Committee report tabled for plenary, 1st reading/single reading
body
EP
docs
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events/5
date
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type
Decision by Parliament, 1st reading
body
EP
docs
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summary
events/5
date
2007-11-29T00:00:00
type
Decision by Parliament, 1st reading/single reading
body
EP
docs
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summary
committees/0
type
Responsible Committee
body
EP
associated
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committee_full
Environment, Public Health and Food Safety
committee
ENVI
rapporteur
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committees/0
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Responsible Committee
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Environment, Public Health and Food Safety
committee
ENVI
date
2007-02-27T00:00:00
rapporteur
name: GROSSETÊTE Françoise group: European People's Party (Christian Democrats) and European Democrats abbr: PPE-DE
docs/2/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2007-277&language=EN
New
http://www.europarl.europa.eu/doceo/document/A-6-2007-0277_EN.html
docs/3/body
EC
events/3/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2007-277&language=EN
New
http://www.europarl.europa.eu/doceo/document/A-6-2007-0277_EN.html
events/5/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2007-556
New
http://www.europarl.europa.eu/doceo/document/TA-6-2007-0556_EN.html
activities
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  • date: 2007-06-26T00:00:00 body: EP committees: body: EP responsible: True committee: ENVI date: 2007-02-27T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: GROSSETÊTE Françoise type: Vote in committee, 1st reading/single reading
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  • date: 2008-03-03T00:00:00 body: CSL type: Council Meeting council: Environment meeting_id: 2856
  • date: 2008-03-03T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading
  • date: 2008-03-11T00:00:00 body: CSL type: Final act signed
  • date: 2008-03-11T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2008-03-20T00:00:00 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=32008L0029 title: Directive 2008/29 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2008:081:TOC title: OJ L 081 20.03.2008, p. 0051
commission
  • body: EC dg: Environment commissioner: DIMAS Stavros
committees/0
type
Responsible Committee
body
EP
associated
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committee_full
Environment, Public Health and Food Safety
committee
ENVI
date
2007-02-27T00:00:00
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
2007-02-27T00:00:00
committee_full
Environment, Public Health and Food Safety
rapporteur
group: PPE-DE name: GROSSETÊTE Françoise
council
  • body: CSL type: Council Meeting council: Environment meeting_id: 2856 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=2856*&MEET_DATE=03/03/2008 date: 2008-03-03T00:00:00
docs
  • date: 2007-06-05T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE390.464 title: PE390.464 type: Committee draft report body: EP
  • date: 2007-06-14T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE390.712 title: PE390.712 type: Amendments tabled in committee body: EP
  • date: 2007-07-05T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2007-277&language=EN title: A6-0277/2007 type: Committee report tabled for plenary, 1st reading/single reading body: EP
  • date: 2007-12-18T00:00:00 docs: url: /oeil/spdoc.do?i=13835&j=0&l=en title: SP(2007)6527 type: Commission response to text adopted in plenary
  • date: 2008-03-11T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F08&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 03692/2007/LEX type: Draft final act body: CSL
events
  • date: 2006-12-22T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2006/0919/COM_COM(2006)0919_EN.pdf title: COM(2006)0919 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2006&nu_doc=919 title: EUR-Lex summary: PURPOSE: to amend Directive 2001/83/EC on the Community code relating to medicinal products for human use by introducing a reference to the new regulatory procedure with scrutiny (comitology). PROPOSED ACT: Directive of the European Parliament and of the Council. CONTENT: Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission has been amended by Council Decision 2006/512/EC ( CNS/2002/0298 ). The amended Decision introduces a new regulatory procedure with scrutiny to be used for measures of general scope which seek to amend non-essential elements of a basic instrument, adopted under co-decision, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements. This procedure allows the legislator to oppose the adoption of "quasi-legislative" measures implementing a codecision-based instrument when it considers that the draft exceeds the implementing powers provided for in the basic instrument, or that the draft is incompatible with the aim or the content of that instrument or fails to respect the principles of subsidiarity or proportionality. In a joint statement, the three institutions agreed on a list of 26 basic instruments already in force to be adjusted without delay in accordance with the new regulatory procedure with scrutiny (see ACI/2006/2152 ). Each case has been assessed on its own merits, notably in view of the nature of the implementing powers conferred on the Commission and the specificity of each sector. Lastly, in accordance with the abovementioned statement, the Commission is proposing to repeal any provisions of these instruments that provide for a time-limit on the delegation of implementing powers to the Commission.
  • date: 2007-01-17T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2007-06-26T00:00:00 type: Vote in committee, 1st reading/single reading body: EP summary: The Committee on the Environment, Public Health and Food Safety adopted by a large majority the report drafted by Francoise GROSSETETE (EPP-ED, FR) and made three amendments to the Commission’s proposal: - a new clause was inserted stating that a list of herbal substances, and preparations and combinations of such substances for use in traditional herbal medicinal products, designed to amend non-essential elements of the Directive by supplementing it, must be established in accordance with the regulatory procedure with scrutiny. This list must contain, with regard to each herbal substance, the indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product; - the final measures designed to amend non-essential elements of the Directive by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny; - whilst the Commission had proposed the deletion of Article 121(4), the Committee felt that this paragraph should remain, since the comitology committee should be obliged to publish its internal rules.
  • date: 2007-07-05T00:00:00 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=A6-2007-277&language=EN title: A6-0277/2007
  • date: 2007-11-29T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=13835&l=en title: Results of vote in Parliament
  • date: 2007-11-29T00:00:00 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-2007-556 title: T6-0556/2007 summary: The European Parliament adopted a resolution drafted by Francoise GROSSETETE (EPP-ED, FR) on the proposal amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission. It made some amendments to the Commission’s proposal: - Article 107 was amended to read that the decision on the final measures concerning the product shall be adopted in accordance with the procedure referred to in Article 121(3). Article 107 concerns a particular medicinal product for which a Member State has considered taking regulatory action on pharmacovigilance grounds; - the rules of procedure of the Standing Committee shall be made public.
  • date: 2008-03-03T00:00:00 type: Act adopted by Council after Parliament's 1st reading body: EP/CSL
  • date: 2008-03-11T00:00:00 type: Final act signed body: CSL
  • date: 2008-03-11T00:00:00 type: End of procedure in Parliament body: EP
  • date: 2008-03-20T00:00:00 type: Final act published in Official Journal summary: PURPOSE: to amend Directive 2001/83/EC on the Community code relating to medicinal products for human use, by introducing a reference to the new regulatory procedure with scrutiny (comitology). LEGISLATIVE ACT: Directive 2008/29/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission. CONTENT: to recall, Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission has been amended by Council Decision 2006/512/EC ( CNS/2002/0298 ). The amended Decision introduces a new regulatory procedure with scrutiny to be used for measures of general scope which seek to amend non-essential elements of a basic instrument, adopted under co-decision. This may include deleting some of those elements or supplementing the instrument, by the addition of new non-essential elements. This procedure allows the legislator to oppose the adoption of "quasi-legislative" measures implementing a codecision-based instrument in cases where: the draft may exceed the implementing powers provided for in the basic instrument; the draft is incompatible with the aim or the content of that instrument; or the draft fails to respect the principles of subsidiarity or proportionality. In a joint statement, the three institutions agreed on a list of 26 basic instruments already in force to be adjusted without delay in accordance with the new regulatory procedure with scrutiny (see ACI/2006/2152 ). Each case has been assessed on the nature of the implementing powers conferred on the Commission and the specificity of each sector. The purpose of this act, therefore, is to amend EU legislation relating to medicinal products for human use, by introducing the new regulatory procedure with scrutiny . ENTRY INTO FORCE: 21 March 2008. docs: title: Directive 2008/29 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32008L0029 title: OJ L 081 20.03.2008, p. 0051 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2008:081:TOC
other
  • body: EC dg: url: http://ec.europa.eu/dgs/environment/ title: Environment commissioner: DIMAS Stavros
procedure/dossier_of_the_committee
Old
ENVI/6/44493
New
  • ENVI/6/44493
procedure/final/url
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32008L0029
New
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32008L0029
procedure/instrument
Old
Directive
New
  • Directive
  • Amending Directive 2001/83/EC 1999/0134(COD)
procedure/subject
Old
  • 4.20.04 Pharmaceutical products and industry
New
4.20.04
Pharmaceutical products and industry
procedure/summary
  • Amending Directive 2001/83/EC
procedure/title
Old
Community code relating to medicinal products for human use: implementing powers of the Commission
New
Community code relating to medicinal products for human use: implementing powers of the Commission
activities/0/docs/0/url
Old
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2006/0919/COM_COM(2006)0919_EN.pdf
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http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2006/0919/COM_COM(2006)0919_EN.pdf
links/European Commission/title
Old
PreLex
New
EUR-Lex
activities
  • date: 2006-12-22T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2006/0919/COM_COM(2006)0919_EN.pdf celexid: CELEX:52006PC0919:EN type: Legislative proposal published title: COM(2006)0919 type: Legislative proposal published body: EC commission: DG: url: http://ec.europa.eu/dgs/environment/ title: Environment Commissioner: DIMAS Stavros
  • date: 2007-01-17T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: True committee: ENVI date: 2007-02-27T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: GROSSETÊTE Françoise
  • date: 2007-06-26T00:00:00 body: EP committees: body: EP responsible: True committee: ENVI date: 2007-02-27T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: GROSSETÊTE Françoise type: Vote in committee, 1st reading/single reading
  • date: 2007-07-05T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2007-277&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A6-0277/2007 body: EP committees: body: EP responsible: True committee: ENVI date: 2007-02-27T00:00:00 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: 2007-11-29T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=13835&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-2007-556 type: Decision by Parliament, 1st reading/single reading title: T6-0556/2007 body: EP type: Results of vote in Parliament
  • date: 2008-03-03T00:00:00 body: CSL type: Council Meeting council: Environment meeting_id: 2856
  • date: 2008-03-03T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading
  • date: 2008-03-11T00:00:00 body: CSL type: Final act signed
  • date: 2008-03-11T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2008-03-20T00:00:00 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=32008L0029 title: Directive 2008/29 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2008:081:TOC title: OJ L 081 20.03.2008, p. 0051
committees
  • body: EP responsible: True committee: ENVI date: 2007-02-27T00:00:00 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/dgs/environment/ title: Environment commissioner: DIMAS Stavros
procedure
dossier_of_the_committee
ENVI/6/44493
reference
2006/0295(COD)
instrument
Directive
legal_basis
EC Treaty (after Amsterdam) EC 095
stage_reached
Procedure completed
summary
Amending Directive 2001/83/EC
subtype
Legislation
title
Community code relating to medicinal products for human use: implementing powers of the Commission
type
COD - Ordinary legislative procedure (ex-codecision procedure)
final
subject
4.20.04 Pharmaceutical products and industry