Legal provisions of COM(2006)640 - Amendment of Regulation xxx/2006 on medicinal products for paediatric use

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dossier COM(2006)640 - Amendment of Regulation xxx/2006 on medicinal products for paediatric use.
document COM(2006)640 EN
date December 20, 2006

Contents

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 supplementing 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 of this Regulation concerning the maximum amounts as 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 European Union.

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