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)
Date: 2006-12-13
Institutions: European Economic and Social Committee
Subjects: European Commission, medicinal product, paediatrics, pharmaceutical legislation, power of implementation, powers of the institutions (EU)

30.12.2006

EN

Official Journal of the European Union

C 325/1

II

(Preparatory Acts)

EUROPEAN ECONOMIC AND SOCIAL COMMITTEE

431ST PLENARY SESSION HELD ON 13-14 DECEMBER 2006

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.

All pending legislative instruments that, subsequent to
1.2
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
regulation xxx/2006 on medicinal
accordingly. Whilst
products
adopted on
formally
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.

this
for paediatric use was

The current Commission proposal amends Regulation
1.3
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 finan-
cial penalties.

2. Recommendation

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

Brussels, 13 December 2006.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS