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
Date: 2006-10-24
Institutions: European Commission
Subjects: European Commission, pharmaceutical legislation, power of implementation, powers of the institutions (EU)

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 24.10.2006 
COM(2006) 640 final 

2006/0207 (COD) 

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 

(presented by the Commission) 

EN 

   EN 

 
 
 
  
EXPLANATORY MEMORANDUM 

Objective 

from 

this  proposal 

the  Commission 

to  amend  Regulation 
The  objective  of 
(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  Commission1,  as  most  recently  amended  by  Council  Decision  2006/512/EC  of 
17 July 20062. 

is 

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(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. 

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. 

1 
2 

OJ L 184, 17.7.1999, p. 23. 
OJ L 200, 22.7.2006, p. 11. 

EN 

2 

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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. 

EN 

3 

   EN 

 
2006/0207 (COD) 

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 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  in  particular  Article  95 
thereof, 

Having regard to the proposal from the Commission3, 

Having regard to the opinion of the European Economic and Social Committee4, 

Having regard to the opinion of the Commission of the Regions5, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty6, 

Whereas: 

(1) 

(2) 

Article  20(2)  and  Article  49(3)  of  Regulation  (EC)  No  xxx/2006  make  provision  for 
the use of the regulatory procedure established by Council Decision 1999/468/EC of 
28 June  1999  laying  down  the  procedures  for  the  exercise  of  implementing  powers 
conferred on the Commission7. 

Decision  1999/468/EC  was  amended  by  Decision  2006/512/EC8  introducing  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. 

(3) 

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

3 
4 
5 
6 
7 
8 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ L 184, 17.7.1999, p. 23. 
OJ L 200, 22.7.2006, p. 11. 

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4 

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HAVE ADOPTED THIS REGULATION: 

Article 51(2) of Regulation (EC) No xxx/2006 is replaced as follows: 

Article 1 

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

This Regulation shall enter into force on the […] day following that of its publication in the 
Official Journal of the European Union. 

Article 2 

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

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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