Opinion of the Commission pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a Directive of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
Date: 2004-02-13
Institutions: European Commission
Subjects: approximation of laws, medical plant, medicinal product, pharmaceutical legislation, public health, single market

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 13.02.2004 
COM(2004) 114 final 

2002/0008 (COD) 

OPINION OF THE COMMISSION 

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, 
on the European Parliament's amendments 
to the Council's common position regarding the  
proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT  
AND OF THE COUNCIL 

amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on 
the Community code relating to medicinal products for human use 

AMENDING THE PROPOSAL OF THE COMMISSION pursuant to Article 250 (2) of the 
EC Treaty 

EN 

   EN 

 
 
 
  
 
 
  
2002/0008 (COD) 

OPINION OF THE COMMISSION 

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, 
on the European Parliament's amendments 
to the Council's common position regarding the  
proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT  
AND OF THE COUNCIL 

amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on 
the Community code relating to medicinal products for human use 

(Text with EEA relevance) 

1. 

INTRODUCTION 

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is 
to  deliver  an  opinion  on  the  amendments  proposed  by  the  European  Parliament  at  second 
reading.  The  Commission  sets  out  below  its  opinion  on  the  two  amendments  proposed  by 
Parliament. 

2. 

BACKGROUND 

Transmission of the proposal to the Council and to the European 
Parliament - COM(2002) 1 final – 2002/0008 (COD) 

17 January 2002 

Opinion of the European Economic and Social Committee   

18 September 2002 

Opinion of the European Parliament – first reading 

21 November 2002 

Amended proposal sent to the Council and the European Parliament 
COM(2003) 161 final – 2002/0008 (COD) 

9 April 2003 

Council common position 

4 November 2003 

Commission Communication on the common position 

5 November 2003 

Opinion of the European Parliament – second reading 

17 December 2003 

3. 

OBJECTIVE OF THE PROPOSAL 

The  proposal  aims  to  guarantee  a  high  level  of  health  protection  for  European  patients  by 
giving  them  access  to  medicines  of  their  choice,  provided  all  the  necessary  safeguards  are 
met.  It  will  also  ensure  a  single  market  for  traditional  herbal  medicines  by  introducing 
harmonised rules and procedures and encouraging cross-border trade in these products, which 
at the moment is very limited. The proposal provides for a simplified registration system for 
traditional herbal products. The quality requirements which will have to be met are the same 

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as  those  for  all  medicinal  products.  However,  to  avoid  unnecessary  testing  and  burdens  on 
firms,  the  legislation  foresees  that  new  pre-clinical  and  clinical  trials  will  not  be  necessary 
when sufficient knowledge already exists about a particular product. 

4. 

COMMISSION’S OPINION ON THE EUROPEAN PARLIAMENT’S AMENDMENTS 

4.1 

General assessment 

The  Commission  can  accept  in  full  the  two  amendments  to  the  Council’s  common  position 
adopted by Parliament. The Council’s common position and Parliament’s amendments make 
certain changes to the Commission’s amended proposal, which are nevertheless in line with 
the objectives and general principles on which the proposal is based. 

4.2 

Analysis of the second reading 

The amendments adopted by Parliament serve mainly to clarify the text of the Directive. 

Amendment 1 confirms that foodstuffs, including plant-based foodstuffs, will continue to be 
governed by legislation on foodstuffs. 
Amendment 2 clarifies the type of herbal substances that the Committee should include in the 
future list, the purpose of which is to provide a harmonised list of the herbal substances likely 
to be used in traditional herbal medicinal products. 

5. 

CONCLUSION 

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out 
above. 

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