Explanatory Memorandum to COM(2006)640 - Amendment of Regulation xxx/2006 on medicinal products for paediatric use - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2006)640 - Amendment of Regulation xxx/2006 on medicinal products for paediatric use. |
|---|---|
| source | COM(2006)640  |
| date | 24-10-2006 |
The objective of this proposal from the Commission is to amend Regulation (EC) No 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 in order to bring it into line with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission i, as most recently amended by Council Decision 2006/512/EC of 17 July 2006 i.
Background
Decision 2006/512/EC introduced a new type of procedure for the exercise of implementing powers, the regulatory procedure with scrutiny. 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.
Content
Regulation (EC) No xxx/2006 makes provision for implementing powers for the Commission through the regulatory procedure:
- in Article 20 i, with a view to further defining the grounds for granting a deferral, and
- in Article 49 i, with regard to the maximum amounts as well as the conditions and methods for collection of financial penalties.
It is necessary to amend Regulation (EC) No xxx/2006 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.
Legal basis
Article 95 of the EC Treaty.
Principle of subsidiarity
The proposal covers a subject for which the Community has exclusive competence. Therefore, the principle of subsidiarity does not apply.
Principle of proportionality
The proposal is in keeping with the principle of proportionality, in that it does not go beyond the amendments that are strictly necessary in order to bring Regulation (EC) No xxx/2006 into line.
Type of instrument
The instrument proposed is a regulation, which is the only suitable instrument given that the proposal is for the amending of an existing regulation.
Budgetary impact
The proposal has no impact on the Community budget.