PURPOSE: to amend Regulation (EC) No 1901/2006 on medicinal products for paediatric use so as to align procedures for implementing measures with new rules on comitology (regulatory procedure with scrutiny).

LEGISLATIVE ACT: Regulation (EC) No 1902/2006 of the European Parliament and of the Council

amending Regulation 1901/2006 on medicinal products for paediatric use.

CONTENT: this amending Regulation provides that the measures necessary for the implementation of Regulation (EC) No 1901/2006 should be adopted in accordance with Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission. In particular, the Commission is 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 maximum amounts as well as the conditions and 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. (Please see COD/2004/0217.)

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 will be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

ENTRY INTO FORCE : 26/01/2007.

The European Parliament adopted a resolution drafted by Françoise GROSSETÊTE (EPP-ED, FR) regarding the proposal for amending the regulation on paediatric medicinal products. An agreement was concluded between the institutions giving rise to the quick adoption of this proposal. The plenary adopted three amendments adapting the new regulation to the new rules on comitology regarding the regulatory procedure with scrutiny.

The committee adopted the report by Françoise GROSSETÊTE (EPP-ED, FR) approving unamended - under the 1st reading of the codecision procedure - the proposed regulation amending the new regulation on medicinal products for paediatric use. The proposal was aimed at introducing into the regulation the new regulatory procedure with scrutiny that is now applicable for the exercise of implementing powers.

PURPOSE: to amend a 2006 Regulation of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation 1768/92/EEC, Directive 2001/20/EC, Directive 2001/83/EC and Regulation 726/2004/EC.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

CONTENT: Decision 2006/512/EC introduced a new type of procedure for the exercise of implementing powers, the regulatory procedure with scrutiny (see CNS/2002/0298 ). It is now necessary to apply the regulatory procedure with scrutiny for measures of general scope designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

The 2006 Regulation makes provision for implementing powers for the Commission through the regulatory procedure:

– 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.

Consequently, it is necessary to amend this Regulation in order to make provision for the adoption of these two implementing measures by the new regulatory procedure with scrutiny, as they are intended to supplement the Regulation by the addition of new non-essential elements.

PURPOSE: to amend a 2006 Regulation of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation 1768/92/EEC, Directive 2001/20/EC, Directive 2001/83/EC and Regulation 726/2004/EC.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

CONTENT: Decision 2006/512/EC introduced a new type of procedure for the exercise of implementing powers, the regulatory procedure with scrutiny (see CNS/2002/0298 ). It is now necessary to apply the regulatory procedure with scrutiny for measures of general scope designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

The 2006 Regulation makes provision for implementing powers for the Commission through the regulatory procedure:

– 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.

Consequently, it is necessary to amend this Regulation in order to make provision for the adoption of these two implementing measures by the new regulatory procedure with scrutiny, as they are intended to supplement the Regulation by the addition of new non-essential elements.