Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission
Date: 2006-12-22
Institutions: European Commission
Subjects: EU law, approximation of laws, legal code, medicinal product, operation of the Institutions, pharmaceutical legislation, public health, single market

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.12.2006 
COM(2006) 919 final 

2006/0295 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending  
Directive 2001/83/EC on the Community code relating to medicinal products for human 
use, as regards the implementing powers conferred on the Commission 

(presented by the Commission) 

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   EN 

 
 
 
  
2006/0295 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
amending  
Directive 2001/83/EC on the Community code relating to medicinal products for human 
use, as regards the implementing powers conferred on the Commission 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

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

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4, 

Whereas: 

(1) 

(2) 

(3) 

1 
2 
3 
4 
5 
6 

7 

Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council5  provides  that 
certain measures 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 Commission6. 

Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced 
the  regulatory  procedure  with  scrutiny  for  measures  of  general  scope  intended  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 them by the addition of new non-essential elements. 

In accordance with the joint statement of the European Parliament, the Council and the 
Commission7 on Decision 2006/512/EC, instruments which are already in force must 
be adjusted in accordance with the applicable procedures. The statement comprises a 
list of instruments to be adapted as a priority, including Directive 2001/83/EC. 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 311, 28.11.2001, p. 67-128 
OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 
OJ C 255, 21.10.2006, p. 1. 

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(4) 

In  particular,  power  should  be  conferred  on  the  Commission  to  adapt  certain 
provisions  and  annexes,  to  adopt  arrangements  and  principles  and  guidelines,  and  to 
lay down specific conditions of application. Since these measures are of general scope 
and  are  designed  to  amend/delete  non-essential  elements  of  Directive  2001/83/EC 
and/or  to  supplement  this  Directive  by  the  addition  of  new  non-essential  elements, 
they  should  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
provided for in Article 5a of Decision 1999/468/EC. 

(5) 

Directive 2001/83/EC should therefore be amended accordingly. 

(6) 

Since the amendments made to Directive 2001/83/EC by this Directive are technical in 
nature  and  concern  committee  procedures  only,  they  do  not  require  transposition  by 
the  Member  States.  Therefore  it  is  not  necessary  to  establish  provisions  for  this 
purpose, 

HAVE ADOPTED THIS DIRECTIVE: 

Directive 2001/83/EC is hereby amended as follows:  

Article 1 

1) The second subparagraph of Article 14(1) is replaced by the following: 

"If new scientific evidence so warrants, the Commission may amend the third indent 
of the first subparagraph. This measure, designed to amend non-essential elements of 
this  Directive,  shall  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny referred to in Article 121(2a)." 

2) The third subparagraph of Article 35(1) is replaced by the following: 

"These  arrangements  shall  be  adopted  by  the  Commission  in  the  form  of  an 
implementing regulation. This measure, designed to amend non-essential elements of 
this  Directive,  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 121(2a)." 

3) The second subparagraph of Article 46(f) is replaced by the following: 

"This point shall also be applicable to certain excipients, the list of which as well as 
the specific conditions of application shall be established by a Directive adopted by 
the  Commission.  This  measure,  designed  to  amend  non-essential  elements  of  this 
Directive,  by  supplementing  it,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 121(2a)." 

4) Article 46a(2) is replaced by the following: 

"The  Commission  shall  be  empowered  to  adapt  paragraph  1  to  take  account  of 
scientific  and  technical  progress.  This  measure,  designed  to  amend  non-essential 
elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 121(2a)." 

5) The first subparagraph of Article 47 is replaced by the following: 

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"The  principles  and  guidelines  of  good  manufacturing  practices  for  medicinal 
products referred to in Article 46(f) shall be adopted in the form of a directive. This 
measure,  designed 
this  Directive,  by 
to  amend  non-essential  elements  of 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 121(2a)." 

6) Article 104(7) is replaced by the following: 

"The Commission may amend paragraph 6 in view of experience gained through its 
operation. This measure, designed to amend non-essential elements of this Directive, 
shall be adopted in accordance with the regulatory procedure with scrutiny referred 
to in Article 121(2a)." 

7) Article 108 is replaced by the following: 

"The  Commission  shall  adopt  any  amendments  which  may  be  necessary  to  update 
provisions of Articles 101 to 107 to take account of scientific and technical progress. 
This  measure,  designed  to  amend  non-essential  elements  of  this  Directive,  shall  be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 121(2a)." 

8) Article 120 is replaced by the following: 

"The  Commission  shall  adopt  any  changes  which  are  necessary  in  order  to  adapt 
Annex  I  to  take  account  of  scientific  and  technical  progress.  These  measures, 
designed  to  amend  non-essential  elements  of  this  Directive,  shall  be  adopted  in 
accordance  with 
in 
Article 121(2a)." 

regulatory  procedure  with  scrutiny 

referred 

the 

to 

9) Article 121 is amended as follows: 

a) The following paragraph 2a is inserted: 

"2a. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision  No 1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof". 

(b) Paragraph 4 is deleted. 

Article 2 

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

Article 3 

This Directive is addressed to the Member States.  

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Done at Brussels, 

For the European Parliament 
President 

For the Council 
President 

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