Document reference

2023/0127(COD)  
Unitary supplementary certificate for medicinal products  
Basic information  

2023/0127(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)
Regulation

Amending Regulation 2006/1901 2004/0217(COD)
Amending Regulation 2013/608 2011/0137(COD)
Amending Regulation 2017/1001 2016/0345(COD)

Subject
3.50.15 Intellectual property, copyright
3.50.16 Industrial property, European patent, Community patent, design and pattern
4.20.04 Pharmaceutical products and industry

Legislative priorities
Joint Declaration 2023-24

Status

Awaiting Council's 1st reading position

 

Key players  
Key events  
27/04/2023
Legislative proposal published
COM(2023)0222 Eur-Lex link
11/09/2023
Committee referral announced in Parliament, 1st reading
24/01/2024
Vote in committee, 1st reading
31/01/2024
Committee report tabled for plenary, 1st reading
A9-0019/2024
27/02/2024
Debate in Parliament
28/02/2024
Decision by Parliament, 1st reading
T9-0097/2024
Technical information  
Procedure reference
2023/0127(COD)
Procedure type
COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype
Legislation
Legislative instrument
Regulation

Amending Regulation 2006/1901 2004/0217(COD)

Amending Regulation 2013/608 2011/0137(COD)

Amending Regulation 2017/1001 2016/0345(COD)

Legal basis
Treaty on the Functioning of the EU TFEU 118-p1
Other legal basis
Rules of Procedure EP 159
Stage reached in procedure
Awaiting Council's 1st reading position
Committee dossier
JURI/9/11896
Documentation gateway  
  • European Parliament 
    Committee draft report
       
    PE753.703  
    13/10/2023
    EP
     
    Amendments tabled in committee
       
    PE756.103  
    13/11/2023
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    A9-0019/2024  
    31/01/2024
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    T9-0097/2024  
    28/02/2024
    EP
  • European Commission 
    Legislative proposal
     
    COM(2023)0222   Eur-Lex link  
    27/04/2023
    EC
    Document attached to the procedure
     
    SWD(2023)0117 Eur-Lex link  
    27/04/2023
    EC
     
    Document attached to the procedure
     
    SWD(2023)0118 Eur-Lex link  
    27/04/2023
    EC
     
    Document attached to the procedure
     
    SWD(2023)0119 Eur-Lex link  
    27/04/2023
    EC
     
  • National parliaments 
    Contribution
    DE_BUNDESRAT
    COM(2023)0222  
    09/11/2023
    NP
     
  • Other institutions 
    Economic and Social Committee: opinion, report
     
    CES2306/2023  
    20/09/2023
    ESC
     
  • All 
    Legislative proposal
       
    COM(2023)0222   Eur-Lex link  
    27/04/2023
    EC
    Document attached to the procedure
       
    SWD(2023)0117 Eur-Lex link  
    27/04/2023
    EC
     
    Document attached to the procedure
       
    SWD(2023)0118 Eur-Lex link  
    27/04/2023
    EC
     
    Document attached to the procedure
       
    SWD(2023)0119 Eur-Lex link  
    27/04/2023
    EC
     
    Economic and Social Committee: opinion, report
       
    CES2306/2023  
    20/09/2023
    ESC
     
    Committee draft report
       
    PE753.703  
    13/10/2023
    EP
     
    Amendments tabled in committee
       
    PE756.103  
    13/11/2023
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    A9-0019/2024  
    31/01/2024
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    T9-0097/2024  
    28/02/2024
    EP
    Contribution
    DE_BUNDESRAT
    COM(2023)0222  
    09/11/2023
    NP
     
Transparency  
Meetings with interest representatives published in line with the Rules of Procedure
  • Rapporteurs, Shadow Rapporteurs and Committee Chairs 
    ZARZALEJOS Javier
    Shadow rapporteur
    JURI  
    23/01/2024
    Chamber of Commerce of the United States of America
    ZARZALEJOS Javier
    Shadow rapporteur
    JURI  
    05/12/2023
    European Federation of Pharmaceutical Industries and Associations
    ZARZALEJOS Javier
    Shadow rapporteur
    JURI  
    04/12/2023
    Bristol-Myers Squibb Company
    VÁZQUEZ LÁZARA Adrián
    Shadow rapporteur
    JURI  
    08/11/2023
    MEDICINES FOR EUROPE
    ZARZALEJOS Javier
    Shadow rapporteur
    JURI  
    08/11/2023
    European Federation of Pharmaceutical Industries and Associations
    ZARZALEJOS Javier
    Shadow rapporteur
    JURI  
    07/11/2023
    Johnson & Johnson
    ZARZALEJOS Javier
    Shadow rapporteur
    JURI  
    06/11/2023
    Bristol-Myers Squibb Company
    WÖLKEN Tiemo
    Rapporteur
    JURI  
    11/10/2023
    EUIPO
    WÖLKEN Tiemo
    Rapporteur
    JURI  
    04/10/2023
    Bristol-Myers Squibb Company
    WÖLKEN Tiemo
    Rapporteur
    JURI  
    19/07/2023
    European Federation of Pharmaceutical Industries and Associations
  • Other Members 
    WÖLKEN Tiemo
    26/06/2023
    Permanent Representation of the Federal Republic of Germany to the European Union