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    Procedure 2012/0192/COD

    COM (2012) 369: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

    Adopted acts: 32014R0536

    European Commission
    Economic and Social Committee
    The European Data Protection Supervisor
    European Parliament
    Council of the European Union
    Legal basis: Commission:
    TFUE/art 114, 164 par 4 pt c
    ;

    Procedure: Ordinary legislative procedure (COD)
    Type of file: Proposal for a Regulation
    Regulation
    EuroVoc thesaurus: +medical research; harmonisation of standards; experiment on humans; medicament; administrative formalities; bio-ethics; market approval; testing
    Directory code: +13.10.30.20 Industrial policy and internal market / Industrial policy: general, programmes, statistics and research / Research and technological development / Research sectors
    13.30.15.00 Industrial policy and internal market / Internal market: approximation of laws / Proprietary medicinal products
    15.30.00.00 Environment, consumers and health protection / Health protection
    European Commission 17/07/2012 : Adoption by Commission
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    Leading person: John DALLI
    Leading service: Directorate-General for Health and Consumers
    Decision mode: Written procedure
    Addressee: European Data Protection Supervisor
    Addressee for formal act: European Parliament ; Council of the European Union
    Addressee for mandatory consultation: Committee of the Regions ; European Economic and Social Committee
    Legal basis: TFUE/art 114, 164 par 4 pt c
    Procedure: Ordinary legislative procedure (COD)
    Type of file: Proposal for a Regulation
    Documents: COM/2012/369/FINAL
    CSST/2012/12751
    IP/2012/795
    CELEX number of the main document: 52012PC0369
    European Commission 17/07/2012 : Transmission to Council
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    European Commission 17/07/2012 : Transmission to Parliament
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    European Commission 17/07/2012 : Supplement
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    Documents: SWD/2012/200/FINAL
    CSST/2012/12751/ADD 2
    CSST/2012/12751/ADD 3
    CELEX number of the main document: 52012SC0200
    European Commission 17/07/2012 : Supplement
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    Documents: SWD/2012/201/FINAL
    CSST/2012/12751/ADD 1
    CELEX number of the main document: 52012SC0201
    European Commission 18/09/2012 : Corrigendum
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    Documents: COM/2012/369/FINAL/2
    CELEX number of the main document: 52012PC0369R(01)
    Economic and Social Committee 12/12/2012 : European Economic and Social Committee opinion
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    Decision mode: Procedure without debate
    Rapporteur: Ingrid KÖSSLER
    Documents: CESE/2012/2059
    JO C/2013/44/99
    CELEX number of the main document: 52012AE2059
    The European Data Protection Supervisor 19/12/2012 : Opinion of the European Data Protection Supervisor
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    Documents: JO C/2013/253/10
    CELEX number of the main document: 52013XX0903(03)
    European Parliament 02/04/2014 : EP opinion on 1st reading
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    Decision: Approval with amendments
    Rapporteur: Glenis WILLMOTT
    Documents: A7/2013/208
    TA/2014/273/P7
    Council of the European Union 14/04/2014 : Approval by the Council of the EP position at 1st reading
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    Type of file: Regulation
    Documents: CS-PRES/2014/8762
    CSST/2014/8569
    Council of the European Union European Parliament 16/04/2014 : Signature by the President of the EP and by the President of the Council
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    Type of file: Regulation
    Documents: CSPE/2014/2
    PE-CONS/2014/2
    JO L/2014/158/1
    CELEX number of the main document: 32014R0536
    European Commission 09/07/2014 : Commission position on EP amendments on 1st reading
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    Decision: Agreement
    Council of the European Union 10/11/2015 : Discussions within the Council or its preparatory bodies
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    Procedure: Ordinary legislative procedure (COD)
    Documents: ST 12987 2015 INIT

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