Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use   (Text with EEA relevance)
Date: 2006-12-20
Institutions: Council of the European Union, European Parliament
Subjects: European Medicines Agency, drug surveillance, market approval, medical research, medicinal product, paediatrics, pharmaceutical legislation, testing

L 378/20

EN

Official Journal of the European Union

27.12.2006

REGULATION (EC) No 1902/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 20 December 2006

amending Regulation 1901/2006 on medicinal products for paediatric use

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

HAVE ADOPTED THIS REGULATION:

Having regard to the Treaty establishing the European Com-
munity, in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and
Social Committee,

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (1),

Whereas:

(1)

(2)

The measures necessary for the implementation of Regu-
lation (EC) No 1901/2006 (2) should be adopted in
accordance with Council Decision 1999/468/EC of 28
June 1999 laying down the procedures for the exercise of
implementing powers conferred on the Commission (3).

In particular, the Commission should be empowered to
define further the grounds for granting a deferral for the
initiation or completion of some or all of the measures
in the paediatric investigation plan and to specify the
the conditions and
maximum amounts as well as
methods for collection of
the financial penalties for
infringement of the provisions of Regulation (EC) No
1901/2006 or
the implementing measures adopted
pursuant to it. Since these measures are of general scope
and are designed to supplement Regulation (EC) No
1901/2006 by the
addition of new non-essential
elements, these measures should be adopted in accord-
ance with the
regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

(3)

It is necessary to amend Regulation (EC) No 1901/2006
accordingly,

(1) Opinion of the European Parliament of 14 December 2006 (not yet
published in the Official Journal) and Council Decision of 19 December
2006.

(2) See page 1 of this Official Journal
(3) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

Article 1

Regulation (EC) No 1901/2006 is hereby amended as follows:

1) in Article 20, paragraph 2 shall be replaced by the following:

‘2.
On the basis of the experience acquired as a result of
the operation of this Article, the Commission may adopt
provisions, in accordance with the regulatory procedure with
scrutiny referred to in Article 51(2), amending or supple-
menting non-essential elements of this Regulation to define
further the grounds for granting a deferral.’;

2) in Article 49, paragraph 3 shall be replaced by the following:

‘3.
At the Agency's request, the Commission may impose
financial penalties for infringement of the provisions of this
Regulation or the implementing measures adopted pursuant
to it in relation to medicinal products authorised through
the procedure laid down in Regulation (EC) No 726/2004.
Measures amending or supplementing non-essential elements
this Regulation concerning the maximum amounts as
of
well as the conditions and methods for collection of those
penalties shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 51(2).’;

3) in Article 51, paragraph 2 shall be replaced by the following:

‘2. Where reference is made to this paragraph, Article 5a
(1) to (4) and Article 7 of Decision 1999/468/EC shall apply,
having regard to the provisions of Article 8 thereof.’.

Article 2

This Regulation shall enter into force on the thirtieth day
following that of its publication in the Official Journal of the Euro-
pean Union.

27.12.2006

EN

Official Journal of the European Union

L 378/21

This Regulation is binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 December 2006

For the European Parliament

The President

J. BORRELL FONTELLES

For the Council

The President

J. KORKEAOJA