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

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
Results of vote 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 165
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
     
    Commission response to text adopted in plenary
     
    SP(2024)270  
    08/07/2024
    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
    Commission response to text adopted in plenary
       
    SP(2024)270  
    08/07/2024
    EC
     
    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