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Regulation (EU) 2020/10432020/0128(COD)COM(2020)261

Conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease

Stage
In force, reached 17 Jul 2020
In force
In force since 18 Jul 2020 · CELEX 32020R1043
Procedure
Ordinary legislative procedure
Lead DG
DG SANTE
Last activity
14 Sept 2020
16 entries · record as of 14 Sept 2026

Where it stands

Latest: Discussions within the Council or its preparatory bodies, 14 Sept 2020.

Show the earlier record: 3 dates, 17 Jun 2020 to 1 Jul 2020
  1. 17 Jun 2020
    • Adoption by Commission
  2. 19 Jun 2020
    • Discussions within the Council or its preparatory bodies
    • Plenary sitting
    • Referred to committee
  3. 1 Jul 2020
    • Discussions within the Council or its preparatory bodies
  1. 3 Jul 2020
    • Discussions within the Council or its preparatory bodies
  2. 8 Jul 2020
    • Plenary vote
    • Plenary sitting
  3. 10 Jul 2020
    • Plenary adopted first-reading position
    • Plenary vote
    • Plenary sitting
  4. 13 Jul 2020
    • Discussions within the Council or its preparatory bodies
  5. 14 Jul 2020
    • Approval of the EP's first reading position by the Council (adoption of the legislative act)
  6. 15 Jul 2020
    • Signed
  7. 17 Jul 2020
    • Published in the Official Journal
  8. 14 Sept 2020
    • Discussions within the Council or its preparatory bodies
4 documents

Documents

Newest first. Each opens at its source.

Summary

Generated

This temporary regulation expedites clinical trials and market supply for COVID-19 treatments and vaccines that are genetically modified organisms (GMOs). It primarily affects pharmaceutical developers, clinical trial sponsors, and national competent authorities for medicines and GMOs. Adopted under an urgent procedure, it entered into force in July 2020.

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Sources: EP Legislative Observatory · EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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