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Ordinary legislative procedure First reading

Unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013

A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.

Where it stands: Parliament adopted its first-reading position on 28 February 2024. Next: negotiations with the Council, unless the Council accepts Parliament’s text as it stands.

  1. ✓ Referred to committee 11 September 2023
  2. ✓ Committee work Report adopted 24 January 2024
  3. ✓ Tabled for plenary 31 January 2024
  4. ✓ Plenary vote Adopted 28 February 2024
  5. 5 Negotiations with the Council
  6. 6 Published as law
How a file moves through Parliament

A file is referred to one lead committee (others may give an opinion). Its rapporteur writes a draft report, committee members table amendments, and the committee votes to adopt the report. The report is then tabled for all MEPs; political groups can table further amendments, which are voted on before the final vote in plenary. For a law, Parliament’s adopted text is its first-reading position; Parliament and the Council then negotiate a common text (trilogues) which both must approve before it is published as law.

Who is working on it

Lead committee
JURI — Legal Affairs
Rapporteur
Tiemo WÖLKEN S&D
Shadow rapporteurs
Javier ZARZALEJOS PPEAdrián VÁZQUEZ LÁZARA RenewMarie TOUSSAINT Verts/ALEMEP #24505 The Left
For opinion
IMCO — Internal Market and Consumer Protection ENVI — Environment, Climate and Food Safety INTA — International Trade

The rapporteur drafts and negotiates the text for the lead committee; each other political group names a shadow rapporteur to follow the file.

The text, version by version

Adopted by Parliament · latest Adopted text TA9-0097/2024 28 February 2024 ✦ Parliament's amended version of a proposed regulation creates a unitary supplementary protection certificate for medicinal products protected by a European patent with unitary effect.⇄ what changed Tabled for plenary Report A9-0019/2024 31 January 2024 ✦ Parliament's amended version of the Commission proposal for a regulation on the unitary supplementary certificate for medicinal products. It sets up a centralised electronic application and examination system run by the Office, with national examiners, and lays down rules on protection, opposition, appeal and fees.⇄ what changed Committee draft Draft report (JURI) 13 October 2023 ✦ This is the rapporteur's draft report on the Commission proposal for a regulation on the unitary supplementary certificate for medicinal products. It adopts Parliament's first-reading position with 62 amendments to the Commission text.

Newest version first. Open a version to read it in full. “What changed” shows the differences paragraph by paragraph; ✦ lines are AI-written from the texts themselves.

Timeline

  1. Plenary stage
  2. 28 February 2024 Plenary vote
    Sitting of 28 February 2024 📄 Adopted text TA9-0097/2024📄 Report A9-0019/2024
    Adopted Adopted by an overwhelming majority
    For 518 Against 29 Abstained 70

    Final vote at 12:50 · 84% of votes cast in favour · every MEP’s position →

    How the vote unfolded · 7 ballots

    adopted rejected lapsed square = amendment circle = part of the text decisive vote Solid = roll call (click for every MEP’s vote); faded = no individual positions

    Show all 7 ballots in voting order
    1. Amendments by the committee responsible — put to the vote collectively Amendments by the committee responsible – put to the vote collectively
    — no individual positions recorded
    Adopted
    2. Separate vote on Article 15
    — no individual positions recorded
    Rejected
    3. Separate vote on Article 15
    electronic vote (totals only) — no individual positions recorded
    Adopted
    4. Separate vote on Article 23
    — no individual positions recorded
    Rejected
    5. Separate vote on Article 23
    — no individual positions recorded
    Adopted
    6. Separate vote on Article 24
    — no individual positions recorded
    Rejected
    7. Final vote 12:50 Certificat complémentaire de protection unitaire pour les médicaments - Unitary supplementary certificate for medicinal products - Einheitliches ergänzendes Zertifikat für Arzneimittel - A9-0019/2024 - Tiemo Wölken - Proposition de la Commission
    Adopted
  3. 27 February 2024 Debated in plenary

    MEPs debated the text in the chamber ahead of the vote.

    Sitting of 27 February 2024 📄 Council / Commission text C9-0146/2023📄 Council / Commission text C9-0147/2023📄 Council / Commission text C9-0148/2023📄 Council / Commission text C9-0149/2023📄 Council / Commission text C9-0152/2023📄 Report A9-0016/2024📄 Report A9-0019/2024📄 Report A9-0020/2024📄 Report A9-0022/2024📄 Report A9-0023/2024
  4. 31 January 2024 Report tabled for plenary

    This is the text all MEPs vote on. Political groups can still table amendments to it.

    📄 Report A9-0019/2024
  5. Committee stage
  6. 24 January 2024 Committee vote: report adopted

    JURI (Legal Affairs) voted on the amendments and adopted the report that goes to plenary.

  7. 13 November 2023 Amendments tabled in committee

    Members of JURI (Legal Affairs) proposed changes to the draft.

    📄 Amendments in committee (JURI)
  8. 13 October 2023 Draft report published

    The rapporteur’s first text in JURI (Legal Affairs). Members can table amendments before the committee votes.

    📄 Draft report (JURI)
  9. 11 September 2023 Referred to the JURI (Legal Affairs) committee

    The lead committee prepares the report; IMCO (Internal Market and Consumer Protection), ENVI (Environment, Climate and Food Safety), INTA (International Trade) give an opinion.