# C_2006325EN.01000101.xml

| 30.12.2006 | EN | Official Journal of the European Union | C 325/1 |
| --- | --- | --- | --- |

30.12.2006

EN

Official Journal of the European Union

C 325/1

---

Opinion of the European Economic and Social Committee on the Proposal for a Regulation of the European Parliament and of the Council amending Regulation xxx/2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004

COM(2006) 640 final — 2006/0207 (COD)

(2006/C 325/01)

On 9 November 2006 the Council decided to consult the European Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the abovementioned proposal.

The Committee Bureau instructed the Section for the Single Market, Production and Consumption to prepare the Committee's work on the subject.

In view of the urgency of the work, the European Economic and Social Committee appointed Ms Heinisch as rapporteur-general at its 431st plenary session, held on 13-14 December 2006 (meeting of 13 December), and adopted the following opinion by 125 votes to none, with one abstention.

1.   Conclusion

| 1.1 | Council Decision 2006/512/EC, which was adopted on 17 July 2006 and amends Council Decision 1999/468/EC, is based on Treaty Article 202. Decision 2006/512/EC introduced a new type of procedure for the exercise of implementing powers, the regulatory procedure with scrutiny. |
| --- | --- |

1.1

Council Decision 2006/512/EC, which was adopted on 17 July 2006 and amends Council Decision 1999/468/EC, is based on Treaty Article 202. Decision 2006/512/EC introduced a new type of procedure for the exercise of implementing powers, the regulatory procedure with scrutiny.

| 1.2 | All pending legislative instruments that, subsequent to the entry into force of Comitology Decision 2006/512/EC, refer to a regulatory procedure of a basic instrument that has been adopted in accordance with the co-decision procedure under Treaty Article 251 but not yet enacted, must be amended accordingly. Whilst this regulation xxx/2006 on medicinal products for paediatric use was formally adopted on 23.10.2006, it has not yet been published in the Official Journal of the European Union and has thus not yet entered into force. |
| --- | --- |

1.2

All pending legislative instruments that, subsequent to the entry into force of Comitology Decision 2006/512/EC, refer to a regulatory procedure of a basic instrument that has been adopted in accordance with the co-decision procedure under Treaty Article 251 but not yet enacted, must be amended accordingly. Whilst this regulation xxx/2006 on medicinal products for paediatric use was formally adopted on 23.10.2006, it has not yet been published in the Official Journal of the European Union and has thus not yet entered into force.

| 1.3 | The current Commission proposal amends Regulation xxx/2006 in order to make provision for the adoption of these two implementing measures, namely Article 20(2) and Article 49(3), by the new regulatory procedure with scrutiny, as they are intended to supplement the Regulation by the addition of new non-essential elements:






  — | in Article 20(2), with a view to further defining the grounds for granting a deferral; and |
| --- | --- | --- |

1.3

The current Commission proposal amends Regulation xxx/2006 in order to make provision for the adoption of these two implementing measures, namely Article 20(2) and Article 49(3), by the new regulatory procedure with scrutiny, as they are intended to supplement the Regulation by the addition of new non-essential elements:

—

in Article 20(2), with a view to further defining the grounds for granting a deferral; and

| — | in Article 49(3), with regard to the maximum amounts as well as the conditions and methods for collection of financial penalties. |
| --- | --- |

—

in Article 49(3), with regard to the maximum amounts as well as the conditions and methods for collection of financial penalties.

2.   Recommendation

| 2.1 | The Commission proposal is fully in line with the procedures and rules according to which implementing powers are assigned to the Commission. The EESC supports the Commission proposal without reservations. |
| --- | --- |

2.1

The Commission proposal is fully in line with the procedures and rules according to which implementing powers are assigned to the Commission. The EESC supports the Commission proposal without reservations.

Brussels, 13 December 2006.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS

---