# CE2012050EN.01007201.xml

| 21.2.2012 | EN | Official Journal of the European Union | CE 50/72 |
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21.2.2012

EN

Official Journal of the European Union

CE 50/72

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Wednesday 22 September 2010Pharmacovigilance (amendment of Directive 2001/83/EC) ***I

P7_TA(2010)0332

European Parliament legislative resolution of 22 September 2010 on the proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM(2008)0665 – C6-0514/2008 – 2008/0260(COD))

2012/C 50 E/16

(Ordinary legislative procedure: first reading)

The European Parliament,

The European Parliament

| — | having regard to the Commission proposal to the European Parliament and the Council (COM(2008)0665), |
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having regard to the Commission proposal to the European Parliament and the Council (COM(2008)0665),

| — | having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0514/2008), |
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having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0514/2008),

| — | having regard to the Communication from the Commission to the European Parliament and the Council entitled ‘Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures’ (COM(2009)0665), |
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having regard to the Communication from the Commission to the European Parliament and the Council entitled ‘Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures’ (COM(2009)0665),

| — | having regard to Article 294(3) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union, |
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having regard to Article 294(3) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union,

| — | having regard to the opinion of the European Economic and Social Committee of 10 June 2009 (1), |
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having regard to the opinion of the European Economic and Social Committee of 10 June 2009 (1),

1

| — | having regard to the opinion of the Committee of the Regions of 7 October 2009 (2), |
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having regard to the opinion of the Committee of the Regions of 7 October 2009 (2),

2

| — | having regard to the undertaking given by the Council representative by letter of 23 June 2010 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 23 June 2010 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

| — | having regard to Rule 55 of its Rules of Procedure, |
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having regard to Rule 55 of its Rules of Procedure,

| — | having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A7-0159/2010), |
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having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A7-0159/2010),

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

Adopts its position at first reading hereinafter set out;

| 2. | Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text; |
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2.

Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

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

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

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(1)  OJ C 306, 16.12.2009, p. 28.

1

(2)  OJ C 79, 27.3.2010, p. 50.

2

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Wednesday 22 September 2010P7_TC1-COD(2008)0260

Position of the European Parliament adopted at first reading on 22 September 2010 with a view to the adoption of Directive 2010/.../EU of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive 2010/84/EU.)

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