# C_2021371EN.01016601.xml

| 15.9.2021 | EN | Official Journal of the European Union | C 371/166 |
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15.9.2021

EN

Official Journal of the European Union

C 371/166

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P9_TA(2020)0203

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 ***I

European Parliament legislative resolution of 10 July 2020 on the proposal for a regulation of the European Parliament and of the Council on the 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 (COM(2020)0261 — C9-0185/2020 — 2020/0128(COD))

(Ordinary legislative procedure: first reading)

(2021/C 371/30)

The European Parliament,

| — | having regard to the Commission proposal to Parliament and the Council (COM(2020)0261), |
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having regard to the Commission proposal to Parliament and the Council (COM(2020)0261),

| — | having regard to Article 294(2) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9-0185/2020), |
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having regard to Article 294(2) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9-0185/2020),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
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having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | after consulting the European Economic and Social Committee, |
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after consulting the European Economic and Social Committee,

| — | after consulting the Committee of the Regions, |
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after consulting the Committee of the Regions,

| — | having regard to the undertaking given by the Council representative by letter of 3 July 2020 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
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having regard to the undertaking given by the Council representative by letter of 3 July 2020 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

| — | having regard to Rules 59 and 163 of its Rules of Procedure, |
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having regard to Rules 59 and 163 of its Rules of Procedure,

| 1. | Adopts its position at first reading hereinafter set out; |
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1.

| 2. | Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal; |
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2.

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
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3.

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P9_TC1-COD(2020)0128

Position of the European Parliament adopted at first reading on 10 July 2020 with a view to the adoption of Regulation (EU) 2020/... of the European Parliament and of the Council on the 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 (COVID-19)

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2020/1043.)

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