2008/0001(COD) | [ParlTrack]

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Procedure completed

2008/0001(COD) Colouring matters for medicinal products. Recast

Role	Committee	Rapporteur	Shadows
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

4.20.04 Pharmaceutical products and industry

Links

Activites

2009/04/30 Final act published in Official Journal
- Directive 2009/35
- OJ L 109 30.04.2009, p. 0010
2009/04/23 Final act signed
2009/04/22 End of procedure in Parliament
#2934
2009/03/23 Council Meeting
2009/03/23 Act adopted by Council after Parliament's 1st reading
2008/09/23 Results of vote in Parliament
- Results of vote in Parliament
- T6-0431/2008 summary
  
  The European Parliament adopted, by 638 votes to 16 with 16 abstentions, a legislative resolution approving 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 report had been tabled for consideration in plenary by József SZAJER (EPP-ED, HU) on behalf of the Committee on Legal Affairs. 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.
2008/07/01 Committee report tabled for plenary, 1st reading/single reading
- A6-0280/2008
2008/06/26 Vote in committee, 1st reading/single reading
2008/02/19 Committee referral announced in Parliament, 1st reading/single reading
2008/01/11 Legislative proposal published
- COM(2008)0001 summary
  
  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 The new Directive was to have superseded the various acts incorporated in it.In the meantime, Council Decision 1999/468/EC which lays down the procedures for the exercise of implementing powers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.
- DG {'url': 'http://ec.europa.eu/dgs/legal_service/', 'title': 'Legal Service'}, BARROSO José Manuel

Documents

Legislative proposal published: COM(2008)0001
Committee report tabled for plenary, 1st reading/single reading: A6-0280/2008
Results of vote in Parliament: Results of vote in Parliament
Decision by Parliament, 1st reading/single reading: T6-0431/2008
: Directive 2009/35
: OJ L 109 30.04.2009, p. 0010

History

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

2019-07-06Show (15) Changes | Timetravel

activities	date: 2008-01-11T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2008/0001/COM_COM(2008)0001_EN.pdf title: COM(2008)0001 type: Legislative proposal published celexid: CELEX:52008PC0001:EN body: EC commission: DG: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service Commissioner: BARROSO José Manuel type: Legislative proposal published date: 2008-02-19T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: False committee: ENVI date: 2008-03-13T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: ULMER Thomas body: EP responsible: True committee: JURI date: 2007-12-19T00:00:00 committee_full: Legal Affairs rapporteur: group: PPE-DE name: SZÁJER József date: 2008-06-26T00:00:00 body: EP committees: body: EP responsible: False committee: ENVI date: 2008-03-13T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: ULMER Thomas body: EP responsible: True committee: JURI date: 2007-12-19T00:00:00 committee_full: Legal Affairs rapporteur: group: PPE-DE name: SZÁJER József type: Vote in committee, 1st reading/single reading date: 2008-07-01T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2008-280&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A6-0280/2008 body: EP committees: body: EP responsible: False committee: ENVI date: 2008-03-13T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: ULMER Thomas body: EP responsible: True committee: JURI date: 2007-12-19T00:00:00 committee_full: Legal Affairs rapporteur: group: PPE-DE name: SZÁJER József type: Committee report tabled for plenary, 1st reading/single reading date: 2008-09-23T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=15321&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-2008-431 type: Decision by Parliament, 1st reading/single reading title: T6-0431/2008 body: EP type: Results of vote in Parliament date: 2009-03-23T00:00:00 body: CSL type: Council Meeting council: Agriculture and Fisheries meeting_id: 2934 date: 2009-03-23T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading date: 2009-04-22T00:00:00 body: EP type: End of procedure in Parliament date: 2009-04-23T00:00:00 body: CSL type: Final act signed date: 2009-04-30T00:00:00 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=32009L0035 title: Directive 2009/35 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2009:109:TOC title: OJ L 109 30.04.2009, p. 0010
commission	body: EC dg: Legal Service commissioner: BARROSO José Manuel
committees/0	type Responsible Committee body EP associated False committee_full Legal Affairs committee JURI date 2007-12-19T00:00:00 rapporteur name: SZÁJER József group: European People's Party (Christian Democrats) and European Democrats abbr: PPE-DE
committees/0	body EP responsible False committee ENVI date 2008-03-13T00:00:00 committee_full Environment, Public Health and Food Safety rapporteur group: PPE-DE name: ULMER Thomas
committees/1	type Committee Opinion body EP associated False committee_full Environment, Public Health and Food Safety committee ENVI date 2008-03-13T00:00:00 rapporteur name: ULMER Thomas group: European People's Party (Christian Democrats) and European Democrats abbr: PPE-DE
committees/1	body EP responsible True committee JURI date 2007-12-19T00:00:00 committee_full Legal Affairs rapporteur group: PPE-DE name: SZÁJER József
council	body: CSL type: Council Meeting council: Agriculture and Fisheries meeting_id: 2934 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=2934*&MEET_DATE=23/03/2009 date: 2009-03-23T00:00:00
docs	date: 2007-11-23T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2007/0740/COM_COM(2007)0740_EN.pdf title: COM(2007)0740 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2007&nu_doc=740 title: EUR-Lex type: For information body: EC date: 2008-02-13T00:00:00 docs: url: https://dm.eesc.europa.eu/EESCDocumentSearch/Pages/redresults.aspx?k=(documenttype:AC)(documentnumber:0266)(documentyear:2008)(documentlanguage:EN) title: CES0266/2008 type: Economic and Social Committee: opinion, report body: ESC date: 2008-06-05T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE404.618&secondRef=02 title: PE404.618 committee: ENVI type: Committee opinion body: EP date: 2008-06-06T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE407.752 title: PE407.752 type: Committee draft report body: EP date: 2008-07-01T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2008-280&language=EN title: A6-0280/2008 type: Committee report tabled for plenary, 1st reading/single reading body: EP date: 2008-10-17T00:00:00 docs: url: /oeil/spdoc.do?i=15321&j=0&l=en title: SP(2008)6073 type: Commission response to text adopted in plenary date: 2009-04-23T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F09&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 03696/2008/LEX type: Draft final act body: CSL
events	date: 2008-01-11T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2008/0001/COM_COM(2008)0001_EN.pdf title: COM(2008)0001 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2008&nu_doc=1 title: EUR-Lex summary: 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. date: 2008-02-19T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP date: 2008-06-26T00:00:00 type: Vote in committee, 1st reading/single reading body: EP summary: 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. date: 2008-07-01T00:00:00 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=A6-2008-280&language=EN title: A6-0280/2008 date: 2008-09-23T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=15321&l=en title: Results of vote in Parliament date: 2008-09-23T00:00:00 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-2008-431 title: T6-0431/2008 summary: The European Parliament adopted, by 638 votes to 16 with 16 abstentions, a legislative resolution approving 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 report had been tabled for consideration in plenary by József SZAJER (EPP-ED, HU) on behalf of the Committee on Legal Affairs. 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. date: 2009-03-23T00:00:00 type: Act adopted by Council after Parliament's 1st reading body: EP/CSL date: 2009-04-22T00:00:00 type: End of procedure in Parliament body: EP date: 2009-04-23T00:00:00 type: Final act signed body: CSL date: 2009-04-30T00:00:00 type: Final act published in Official Journal summary: 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. docs: title: Directive 2009/35 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009L0035 title: OJ L 109 30.04.2009, p. 0010 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2009:109:TOC
other	body: EC dg: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service commissioner: BARROSO José Manuel
procedure/dossier_of_the_committee	Old JURI/6/58182 New JURI/6/58182
procedure/final/url	Old http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009L0035 New https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009L0035
procedure/instrument	Old Directive New Directive Repealing Directives 78/25/EEC, 81/464/EEC Repealing Regulation (EC) No 807/2003, Annex III, point 25 2001/0316(CNS)
procedure/subject	Old 4.20.04 Pharmaceutical products and industry New 4.20.04 Pharmaceutical products and industry
procedure/summary	Repealing Directives 78/25/EEC, 81/464/EEC Repealing Regulation (EC) No 807/2003, Annex III, point 25

2015-11-04Show (2) Changes | Timetravel

activities/0/docs/0/url	Old http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2008/0001/COM_COM(2008)0001_EN.pdf New http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2008/0001/COM_COM(2008)0001_EN.pdf
links/European Commission/title	Old PreLex New EUR-Lex

2014-11-10Show (5) Changes

activities	date: 2008-01-11T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2008/0001/COM_COM(2008)0001_EN.pdf celexid: CELEX:52008PC0001:EN type: Legislative proposal published title: COM(2008)0001 type: Legislative proposal published body: EC commission: DG: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service Commissioner: BARROSO José Manuel date: 2008-02-19T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: False committee: ENVI date: 2008-03-13T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: ULMER Thomas body: EP responsible: True committee: JURI date: 2007-12-19T00:00:00 committee_full: Legal Affairs rapporteur: group: PPE-DE name: SZÁJER József date: 2008-06-26T00:00:00 body: EP committees: body: EP responsible: False committee: ENVI date: 2008-03-13T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: ULMER Thomas body: EP responsible: True committee: JURI date: 2007-12-19T00:00:00 committee_full: Legal Affairs rapporteur: group: PPE-DE name: SZÁJER József type: Vote in committee, 1st reading/single reading date: 2008-07-01T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2008-280&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A6-0280/2008 body: EP committees: body: EP responsible: False committee: ENVI date: 2008-03-13T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: ULMER Thomas body: EP responsible: True committee: JURI date: 2007-12-19T00:00:00 committee_full: Legal Affairs rapporteur: group: PPE-DE name: SZÁJER József type: Committee report tabled for plenary, 1st reading/single reading date: 2008-09-23T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=15321&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-2008-431 type: Decision by Parliament, 1st reading/single reading title: T6-0431/2008 body: EP type: Results of vote in Parliament date: 2009-03-23T00:00:00 body: CSL type: Council Meeting council: Agriculture and Fisheries meeting_id: 2934 date: 2009-03-23T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading date: 2009-04-22T00:00:00 body: EP type: End of procedure in Parliament date: 2009-04-23T00:00:00 body: CSL type: Final act signed date: 2009-04-30T00:00:00 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=32009L0035 title: Directive 2009/35 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2009:109:TOC title: OJ L 109 30.04.2009, p. 0010
committees	body: EP responsible: False committee: ENVI date: 2008-03-13T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: ULMER Thomas body: EP responsible: True committee: JURI date: 2007-12-19T00:00:00 committee_full: Legal Affairs rapporteur: group: PPE-DE name: SZÁJER József
links	National parliaments url: http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2008&number=0001&appLng=EN title: IPEX European Commission url: http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2008&DocNum=0001 title: PreLex
other	body: EC dg: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service commissioner: BARROSO José Manuel
procedure	dossier_of_the_committee JURI/6/58182 reference 2008/0001(COD) instrument Directive legal_basis EC Treaty (after Amsterdam) EC 095 stage_reached Procedure completed summary Repealing Directives 78/25/EEC, 81/464/EEC Repealing Regulation (EC) No 807/2003, Annex III, point 25 subtype Recast title Colouring matters for medicinal products. Recast type COD - Ordinary legislative procedure (ex-codecision procedure) final url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009L0035 title: Directive 2009/35 subject 4.20.04 Pharmaceutical products and industry

Activites

Documents

History

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