BETA


2008/0126(COD) Supplementary protection certificate for medicinal products. Codification

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead JURI WALLIS Diana (icon: ALDE ALDE)
Lead committee dossier:
Legal Basis:
EC Treaty (after Amsterdam) EC 095

Events

2009/06/16
   Final act published in Official Journal
Details

PURPOSE: to codify Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products.

LEGISLATIVE ACT: Regulation (EC) No 469/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products

CONTENT: the aim of this Regulation is to codify Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products. The new Regulation will supersede the various acts incorporated into it. It fully preserves the content of the acts being codified and hence does no more than bring them together with only such formal amendments as are required by the codification exercise itself.

Regulation (EEC) No 1768/92, as amended by the acts listed in Annex I, is repealed.

ENTRY INTO FORCE: 6 July 2009.

2009/05/06
   CSL - Draft final act
Documents
2009/05/06
   CSL - Final act signed
2009/05/06
   EP - End of procedure in Parliament
2009/04/06
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2009/04/06
   CSL - Council Meeting
2008/10/21
   EP - Results of vote in Parliament
2008/10/21
   EP - Decision by Parliament, 1st reading/single reading
Details

The European Parliament adopted, by 654 votes to 14 with 8 abstentions, under 1st reading of the codecision procedure, a legislative resolution approving the proposal for a regulation of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products (codified version). The report had been tabled for consideration in plenary by Diana WALLIS (ALDE, UK) on behalf of the Legal Affairs Committee. The Commission 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.

Documents
2008/10/09
   EP - Committee report tabled for plenary, 1st reading/single reading
Documents
2008/10/09
   EP - Committee report tabled for plenary, 1st reading/single reading
Documents
2008/10/07
   EP - Vote in committee, 1st reading/single reading
Details

The Legal Affairs Committee adopted a report drafted by Diana WALLIS (ALDE, UK) and approved the proposal on the codification of Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products. The Commission’s 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.

2008/09/17
   ESC - Economic and Social Committee: opinion, report
Documents
2008/06/25
   EP - WALLIS Diana (ALDE) appointed as rapporteur in JURI
2008/06/19
   EP - Committee referral announced in Parliament, 1st reading/single reading
2008/06/17
   EC - Legislative proposal published
Details

PURPOSE: to codify Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products.

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

CONTENT: the purpose of this proposal is to undertake a codification of Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products. The new Regulation will supersede the various acts incorporated into it. This proposal fully preserves the content of the acts being codified and hence does no more than bring them together with only such formal amendments as are required by the codification exercise itself.

The codification proposal was drawn up on the basis of a preliminary consolidation, in all official languages, of Regulation (EEC) No 1768/92 and the instruments amending it, carried out by the Office for Official Publications of the European Communities, by means of a data-processing system. Where the Articles have been given new numbers, the correlation between the old and the new numbers is shown in a table set out in Annex II to the codified Regulation.

Documents

Votes

Rapport Wallis A6-0385/2008 - résolution

2008/10/21 Outcome: +: 654, -: 14, 0: 8
DE IT FR ES PL GB RO NL EL HU BE PT SE CZ AT IE FI SK BG DK LT LV EE SI CY LU MT
Total
87
61
63
51
48
72
27
26
22
21
20
20
19
19
16
13
13
13
12
12
9
8
6
5
5
6
2
icon: PPE-DE PPE-DE
255

Denmark PPE-DE

1

Lithuania PPE-DE

1

Estonia PPE-DE

For (1)

1

Slovenia PPE-DE

3

Cyprus PPE-DE

2

Luxembourg PPE-DE

3

Malta PPE-DE

2
icon: PSE PSE
184

Czechia PSE

2

Ireland PSE

1

Lithuania PSE

For (1)

1

Estonia PSE

3

Luxembourg PSE

For (1)

1
icon: ALDE ALDE
87

Hungary ALDE

1

Sweden ALDE

3

Austria ALDE

1

Ireland ALDE

For (1)

1

Latvia ALDE

1

Estonia ALDE

2

Slovenia ALDE

2

Cyprus ALDE

For (1)

1

Luxembourg ALDE

For (1)

1
icon: GUE/NGL GUE/NGL
37

United Kingdom GUE/NGL

1

Netherlands GUE/NGL

2

Portugal GUE/NGL

3

Sweden GUE/NGL

2

Ireland GUE/NGL

1

Finland GUE/NGL

For (1)

1

Denmark GUE/NGL

1

Cyprus GUE/NGL

2
icon: Verts/ALE Verts/ALE
35

Italy Verts/ALE

2

United Kingdom Verts/ALE

3

Belgium Verts/ALE

2

Sweden Verts/ALE

For (1)

1

Austria Verts/ALE

2

Finland Verts/ALE

For (1)

1

Denmark Verts/ALE

For (1)

1

Latvia Verts/ALE

1

Luxembourg Verts/ALE

Abstain (1)

1
icon: UEN UEN
32

Denmark UEN

For (1)

1
icon: NI NI
26

United Kingdom NI

For (1)

Abstain (1)

7

Belgium NI

2

Czechia NI

1

Austria NI

2

Bulgaria NI

For (1)

1
icon: IND/DEM IND/DEM
20

Poland IND/DEM

3

Netherlands IND/DEM

2

Sweden IND/DEM

2

Ireland IND/DEM

For (1)

1

Denmark IND/DEM

For (1)

1

History

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

committees/0
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Responsible Committee
body
EP
associated
False
committee_full
Legal Affairs
committee
JURI
rapporteur
name: WALLIS Diana date: 2008-06-25T00:00:00 group: Alliance of Liberals and Democrats for Europe abbr: ALDE
committees/0
type
Responsible Committee
body
EP
associated
False
committee_full
Legal Affairs
committee
JURI
date
2008-06-25T00:00:00
rapporteur
name: WALLIS Diana group: Alliance of Liberals and Democrats for Europe abbr: ALDE
docs/1/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2008-385&language=EN
New
http://www.europarl.europa.eu/doceo/document/A-6-2008-0385_EN.html
events/3/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2008-385&language=EN
New
http://www.europarl.europa.eu/doceo/document/A-6-2008-0385_EN.html
events/5/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2008-482
New
http://www.europarl.europa.eu/doceo/document/TA-6-2008-0482_EN.html
events/9/docs/1/url
Old
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2009:152:TOC
New
https://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2009:152:SOM:EN:HTML
activities
  • date: 2008-06-17T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2008/0369/COM_COM(2008)0369_EN.pdf title: COM(2008)0369 type: Legislative proposal published celexid: CELEX:52008PC0369:EN body: EC commission: DG: url: http://ec.europa.eu/dgs/internal_market/ title: Internal Market and Services Commissioner: MCCREEVY Charlie type: Legislative proposal published
  • date: 2008-06-19T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: True committee: JURI date: 2008-06-25T00:00:00 committee_full: Legal Affairs rapporteur: group: ALDE name: WALLIS Diana
  • date: 2008-10-07T00:00:00 body: EP committees: body: EP responsible: True committee: JURI date: 2008-06-25T00:00:00 committee_full: Legal Affairs rapporteur: group: ALDE name: WALLIS Diana type: Vote in committee, 1st reading/single reading
  • date: 2008-10-09T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2008-385&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A6-0385/2008 body: EP committees: body: EP responsible: True committee: JURI date: 2008-06-25T00:00:00 committee_full: Legal Affairs rapporteur: group: ALDE name: WALLIS Diana type: Committee report tabled for plenary, 1st reading/single reading
  • date: 2008-10-21T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=16161&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-2008-482 type: Decision by Parliament, 1st reading/single reading title: T6-0482/2008 body: EP type: Results of vote in Parliament
  • date: 2009-04-06T00:00:00 body: CSL type: Council Meeting council: Justice and Home Affairs (JHA) meeting_id: 2936
  • date: 2009-04-06T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading
  • date: 2009-05-06T00:00:00 body: CSL type: Final act signed
  • date: 2009-05-06T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2009-06-16T00:00:00 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=32009R0469 title: Regulation 2009/469 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2009:152:TOC title: OJ L 152 16.06.2009, p. 0001
commission
  • body: EC dg: Financial Stability, Financial Services and Capital Markets Union commissioner: MCCREEVY Charlie
committees/0
type
Responsible Committee
body
EP
associated
False
committee_full
Legal Affairs
committee
JURI
date
2008-06-25T00:00:00
rapporteur
name: WALLIS Diana group: Alliance of Liberals and Democrats for Europe abbr: ALDE
committees/0
body
EP
responsible
True
committee
JURI
date
2008-06-25T00:00:00
committee_full
Legal Affairs
rapporteur
group: ALDE name: WALLIS Diana
council
  • body: CSL type: Council Meeting council: Justice and Home Affairs (JHA) meeting_id: 2936 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=2936*&MEET_DATE=06/04/2009 date: 2009-04-06T00:00:00
docs
  • date: 2008-09-17T00:00:00 docs: url: https://dm.eesc.europa.eu/EESCDocumentSearch/Pages/redresults.aspx?k=(documenttype:AC)(documentnumber:1510)(documentyear:2008)(documentlanguage:EN) title: CES1510/2008 type: Economic and Social Committee: opinion, report body: ESC
  • date: 2008-10-09T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2008-385&language=EN title: A6-0385/2008 type: Committee report tabled for plenary, 1st reading/single reading body: EP
  • date: 2009-05-06T00:00:00 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: 03602/2009/LEX type: Draft final act body: CSL
events
  • date: 2008-06-17T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2008/0369/COM_COM(2008)0369_EN.pdf title: COM(2008)0369 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2008&nu_doc=369 title: EUR-Lex summary: PURPOSE: to codify Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products. PROPOSED ACT: Regulation of the European Parliament and of the Council. CONTENT: the purpose of this proposal is to undertake a codification of Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products. The new Regulation will supersede the various acts incorporated into it. This proposal fully preserves the content of the acts being codified and hence does no more than bring them together with only such formal amendments as are required by the codification exercise itself. The codification proposal was drawn up on the basis of a preliminary consolidation, in all official languages, of Regulation (EEC) No 1768/92 and the instruments amending it, carried out by the Office for Official Publications of the European Communities, by means of a data-processing system. Where the Articles have been given new numbers, the correlation between the old and the new numbers is shown in a table set out in Annex II to the codified Regulation.
  • date: 2008-06-19T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2008-10-07T00:00:00 type: Vote in committee, 1st reading/single reading body: EP summary: The Legal Affairs Committee adopted a report drafted by Diana WALLIS (ALDE, UK) and approved the proposal on the codification of Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products. The Commission’s 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: 2008-10-09T00:00:00 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=A6-2008-385&language=EN title: A6-0385/2008
  • date: 2008-10-21T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=16161&l=en title: Results of vote in Parliament
  • date: 2008-10-21T00:00:00 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-2008-482 title: T6-0482/2008 summary: The European Parliament adopted, by 654 votes to 14 with 8 abstentions, under 1st reading of the codecision procedure, a legislative resolution approving the proposal for a regulation of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products (codified version). The report had been tabled for consideration in plenary by Diana WALLIS (ALDE, UK) on behalf of the Legal Affairs Committee. The Commission 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: 2009-04-06T00:00:00 type: Act adopted by Council after Parliament's 1st reading body: EP/CSL
  • date: 2009-05-06T00:00:00 type: Final act signed body: CSL
  • date: 2009-05-06T00:00:00 type: End of procedure in Parliament body: EP
  • date: 2009-06-16T00:00:00 type: Final act published in Official Journal summary: PURPOSE: to codify Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products. LEGISLATIVE ACT: Regulation (EC) No 469/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products CONTENT: the aim of this Regulation is to codify Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products. The new Regulation will supersede the various acts incorporated into it. It fully preserves the content of the acts being codified and hence does no more than bring them together with only such formal amendments as are required by the codification exercise itself. Regulation (EEC) No 1768/92, as amended by the acts listed in Annex I, is repealed. ENTRY INTO FORCE: 6 July 2009. docs: title: Regulation 2009/469 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009R0469 title: OJ L 152 16.06.2009, p. 0001 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2009:152:TOC
other
  • body: EC dg: url: http://ec.europa.eu/dgs/internal_market/ title: Internal Market and Services commissioner: MCCREEVY Charlie
procedure/dossier_of_the_committee
Old
JURI/6/64375
New
  • JURI/6/64375
procedure/final/url
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009R0469
New
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009R0469
procedure/instrument
Old
Regulation
New
  • Regulation
  • Repealing Regulation ((EEC) No 1768/92 Amended by 2018/0161(COD)
procedure/subject
Old
  • 3.50.16 Industrial property, European patent, Community patent, design and pattern
  • 4.20.02 Medical research
  • 4.20.04 Pharmaceutical products and industry
New
3.50.01.05
Research specific areas
3.50.16
Industrial property, European patent, Community patent, design and pattern
4.20.04
Pharmaceutical products and industry
procedure/summary
  • Repealing Regulation ((EEC) No 1768/92
procedure/title
Old
Medicinal products: supplementary protection certificate. Codification
New
Supplementary protection certificate for medicinal products. Codification
activities/0/docs/0/url
Old
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2008/0369/COM_COM(2008)0369_EN.pdf
New
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2008/0369/COM_COM(2008)0369_EN.pdf
links/European Commission/title
Old
PreLex
New
EUR-Lex
activities
  • date: 2008-06-17T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2008/0369/COM_COM(2008)0369_EN.pdf celexid: CELEX:52008PC0369:EN type: Legislative proposal published title: COM(2008)0369 type: Legislative proposal published body: EC commission: DG: url: http://ec.europa.eu/dgs/internal_market/ title: Internal Market and Services Commissioner: MCCREEVY Charlie
  • date: 2008-06-19T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: True committee: JURI date: 2008-06-25T00:00:00 committee_full: Legal Affairs rapporteur: group: ALDE name: WALLIS Diana
  • date: 2008-10-07T00:00:00 body: EP committees: body: EP responsible: True committee: JURI date: 2008-06-25T00:00:00 committee_full: Legal Affairs rapporteur: group: ALDE name: WALLIS Diana type: Vote in committee, 1st reading/single reading
  • date: 2008-10-09T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2008-385&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A6-0385/2008 body: EP committees: body: EP responsible: True committee: JURI date: 2008-06-25T00:00:00 committee_full: Legal Affairs rapporteur: group: ALDE name: WALLIS Diana type: Committee report tabled for plenary, 1st reading/single reading
  • date: 2008-10-21T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=16161&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-2008-482 type: Decision by Parliament, 1st reading/single reading title: T6-0482/2008 body: EP type: Results of vote in Parliament
  • date: 2009-04-06T00:00:00 body: CSL type: Council Meeting council: Justice and Home Affairs (JHA) meeting_id: 2936
  • date: 2009-04-06T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading
  • date: 2009-05-06T00:00:00 body: CSL type: Final act signed
  • date: 2009-05-06T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2009-06-16T00:00:00 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=32009R0469 title: Regulation 2009/469 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2009:152:TOC title: OJ L 152 16.06.2009, p. 0001
committees
  • body: EP responsible: True committee: JURI date: 2008-06-25T00:00:00 committee_full: Legal Affairs rapporteur: group: ALDE name: WALLIS Diana
links
National parliaments
European Commission
other
  • body: EC dg: url: http://ec.europa.eu/dgs/internal_market/ title: Internal Market and Services commissioner: MCCREEVY Charlie
procedure
dossier_of_the_committee
JURI/6/64375
reference
2008/0126(COD)
instrument
Regulation
legal_basis
EC Treaty (after Amsterdam) EC 095
stage_reached
Procedure completed
summary
Repealing Regulation ((EEC) No 1768/92
subtype
Codification
title
Medicinal products: supplementary protection certificate. Codification
type
COD - Ordinary legislative procedure (ex-codecision procedure)
final
subject