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DRAFT RECOMMENDATION FOR SECOND READING (07106/2/2026– C100244/2026 – 2023/0132(COD))

On the Council position at first reading with a view to the adoption of a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directives 2001/83/EC and 2009/35/EC

SANT-PR-796189

Committee on Public Health · Rapporteur: Dolors Montserrat

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

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This is a draft report on the Council's first-reading position for a directive establishing a Union code on medicinal products for human use and repealing Directives 2001/83/EC and 2009/35/EC. The rapporteur proposes that Parliament approve the Council position, note that the act is adopted accordingly, and arrange for signature and publication. The 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, note that the act is adopted accordingly, and arrange for signature and publication.

Key points

  1. Parliament approves the Council's first-reading position on the directive on a Union code for medicinal products for human use.
  2. Parliament notes that the act is adopted in accordance with the Council position.
  3. Parliament instructs its President to sign the act with the President of the Council, in line with Article 297(1) of the Treaty on the Functioning of the European Union.
  4. Parliament instructs its Secretary-General to sign the act once all procedures are verified and to arrange publication in the Official Journal of the European Union with the Council's Secretary-General.
  5. Parliament instructs its President to forward its position to the Council, the Commission and the national parliaments.
  6. The Council position reflects the agreement reached between Parliament and the Council in interinstitutional negotiations at early second reading stage.

Who is affected

  • Manufacturers and users of medicinal products for human use, who would be covered by the new Union code.
  • The Council, the Commission and the national parliaments, which receive Parliament's position.

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