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DRAFT RECOMMENDATION FOR SECOND READING (07105/2/2026– C100243/2026 – 2023/0131(COD))

On the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

SANT-PR-796377

Committee on Public Health · Rapporteur: Tiemo Wölken

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✦ In short · AI summary of this text, generated 28 Oct 2026

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This is the rapporteur's draft report on the Council's first-reading position for a regulation on Union procedures for authorising and supervising medicinal products for human use and on rules for the European Medicines Agency. It recommends that Parliament approve the Council position. The regulation would amend Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repeal Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006. The draft notes that the act is adopted in line with the Council position and sets out the signing and publication steps. The short justification says the Council position reflects the agreement reached between Parliament and the Council in interinstitutional negotiations at early second reading stage.

Committee position. The rapporteur proposes that Parliament approve the Council's first-reading position, noting that the act is adopted in accordance with it and setting out the signing and publication steps.

Key points

  1. The draft report concerns the Council's first-reading position on a regulation laying down Union procedures for authorising and supervising medicinal products for human use and establishing rules for the European Medicines Agency.
  2. The regulation would amend Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014.
  3. The regulation would repeal Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006.
  4. The rapporteur proposes that Parliament approve the Council position at first reading.
  5. The draft notes that the act is adopted in accordance with the Council position.
  6. Parliament's President is to sign the act with the President of the Council, in accordance with Article 297(1) of the Treaty on the Functioning of the European Union.
  7. Parliament's Secretary-General is to sign the act once all procedures are verified as duly completed and, in agreement with the Council's Secretary-General, arrange publication in the Official Journal of the European Union.
  8. The short justification states that the Council position reflects the agreement reached between Parliament and the Council in interinstitutional negotiations at early second reading stage.

Who is affected

  • Developers and holders of authorisations for medicinal products for human use, who would work under the new authorisation and supervision procedures.
  • The European Medicines Agency, whose governing rules the regulation would establish.

Legal basis: Article 294(7) of the Treaty on the Functioning of the European Union