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 Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Medicines Agency amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
Date: 2004-02-17
Institutions: European Commission
Subjects: European Medicines Agency, drug surveillance, market approval, medicinal product, pharmaceutical legislation, public health, veterinary drug

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 17.2.2004 
COM(2004) 124 final 

2001/0252 (COD) 
2001/0253 (COD) 
2001/0254 (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  
proposals for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

laying down Community procedures for the authorisation, supervision and 
pharmacovigilance of medicinal products for human and veterinary use and establishing 
a European Medicines Agency 

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 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Directive 2001/82/EC on the Community code relating to veterinary medicinal 
products  

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

EN 

   EN 

 
 
 
  
 
 
 
2001/0252 (COD) 
2001/0253 (COD) 
2001/0254 (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  
proposals for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

laying down Community procedures for the authorisation, supervision and 
pharmacovigilance of medicinal products for human and veterinary use and establishing 
a European Medicines Agency 

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 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Directive 2001/82/EC on the Community code relating to veterinary medicinal 
products  

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  34  amendments  proposed  by 
Parliament. 

2. 

BACKGROUND 

Proposal sent to the Council and the European Parliament 
COM(2001) 404 final – 2001/0252 (COD) – 2001/0253 (COD) – 
2001/0254 (COD) 

26 November 2001 

Opinion of the European Economic and Social Committee 

18 September 2002 

Opinion of the European Parliament – first reading 

23 October 2002 

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Amended proposal sent to the Council and the European Parliament 
COM(2002) 735 final – 2001/0252 (COD) 

12 December 2002 

Amended proposal sent to the Council and the European Parliament 
COM(2003) 163 final – 2001/0253 (COD) and 2001/0254 (COD) 

Council common positions 

24 April 2003 

29 September 2003 

Commission Communication on the common position 

7 October 2003 

Opinion of the European Parliament – second reading 

17 December 2003 

3. 

OBJECTIVE OF THE PROPOSAL 

Regulation  2309/93  makes  provision  for  the  evaluation  of  the  Community  procedures  for  the 
authorisation  and  supervision  of  medicinal  products  which  entered  into  force  in  1995.  In  the 
light of the experience acquired from 1995 to 2000, and the Commission’s analysis in its report 
“on  the  operation  of  the  procedures  for  granting  marketing  authorisations  for  medicinal 
products”  (COM(2001)  606  final,  23.10.2001),  it  appeared  necessary  to  adapt  Regulation 
2309/93  and  Directives  2001/83/EC  and  2001/82/EC  on  the  Community  codes  relating  to 
medicinal products for human use and for veterinary use.  

Generally speaking, four main objectives are particularly relevant: 

(1) 

(2) 

(3) 

(4) 

to guarantee a high level of public health protection, particularly by providing patients, 
as swiftly as possible, with innovative and reliable products and by increasing market 
surveillance by reinforcing monitoring and pharmacovigilance procedures; 

to complete the internal market in pharmaceutical products while taking account of the 
implications  of  globalisation,  and  to  establish  a regulatory  and legislative framework 
that favours the competitiveness of the European pharmaceuticals sector; 

to meet the challenges of the future enlargement of the European Union; 

to  rationalise  and  simplify  the  system,  thus  improving  its  overall  consistency  and 
visibility, and the transparency of procedures 

Lastly, with regard to veterinary medicinal products, the proposals intend to specifically address 
the problem of availability of such medicinal products. 

4. 

COMMISSION’S OPINION ON THE EUROPEAN PARLIAMENT'S AMENDMENTS 

4.1 

General assessment 

The  Commission  can  accept  in  full  the  32  amendments  to  the  Council’s  common  position 
adopted by Parliament on the proposal for a regulation, the 30 amendments to the Council’s 
common position adopted by Parliament on the proposal for a directive on medicinal products 
for  human  use  and  the  22  amendments  to  the  Council's  common  position  adopted  by 
Parliament on the proposal for a directive on veterinary medicinal products.  

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The Commission notes the convergence of views between the three institutions on the general 
approach and on the most important issues regarding the compulsory field of application of 
the  centralised  procedure,  the  administrative  structure  of  the  agency,  the  period  of  data 
protection,  definitions,  information  for  patients  and  the  assessment  of  the  environmental 
impact.  Parliament’s  amendments  make  certain  changes  and  clarifications  to  the  Council’s 
common position, which are nevertheless consistent with the objectives and general principles 
on which the Commission’s proposals are based. 

4.2 

Analysis of the second reading 

The amendments adopted by Parliament mainly concern the issues of the compulsory field of 
application of the centralised procedure, the period of data protection and the administrative 
structure of the agency as far as the regulation is concerned, and the definitions, period of data 
protection, information for patients and assessment of the environmental impact as regards the 
two directives on medicinal products for human use and veterinary use.  

4.2.1  Regulation  laying  down  Community  procedures  for  the  authorisation  and 
supervision of medicinal products for human and veterinary use and establishing a 
European Medicines Agency. 

- Compulsory field of application of the centralised procedure (amendments 44, 56 and 63): 

Parliament  has  requested  an  extension  of  the  compulsory  field  of  application  of  the 
compulsory  centralised  procedure.  The  Council’s  common  position  provided  for  application 
of the procedure to new medicinal products for the treatment of four diseases, namely AIDs, 
cancer, diabetes and neurodegenerative disorders. Parliament added a fourth category, orphan 
medicinal products pursuant to Regulation (EC) No 141/2000 of the European Parliament and 
of  the  Council.  It  also  provided  that  four  years  after  entry  into  force  of  the  Regulation,  the 
procedure  would  also  obligatorily  cover  new  medicinal  products  for  the  treatment  of  auto-
immune diseases and other immune dysfunctions and viral diseases. A revision clause with an 
ad  hoc  procedure  is  also  provided  for.  The  Commission  considers  that  the  proposed 
amendments  would  significantly  strengthen  application  of  the  authorisation  procedure  and 
allow greater accessibility to new medicinal products throughout the Community. 

- Administrative structure of the agency (amendments 59 and 60): 

The amendments proposed by Parliament aim to strengthen, on the one hand, the provisions 
on the appointment of members of the scientific committees and, on the other, the provisions 
on  the  composition  of  the  Management  Board.  For  the  scientific  committees,  Parliament 
introduces  the  obligation  for  the  Member  States  to  consult  the  Management  Board  before 
finalising the appointment procedures for these committees. Parliament wishes in this way to 
give the Management Committee of the Agency the possibility of influencing the composition 
of the committees in order to guarantee the presence of sufficient experts to cover the various 
scientific fields for the evaluation of medicinal products. As regards the Management Board, 
Parliament  wants  its  composition  also  to  include  representatives  of  Parliament  itself  and,  in 
particular, representatives of civil society, patients, doctors and veterinary surgeons. 

The  Commission  believes  the  proposed  amendments  are  on  the  right  lines  and  are  a  good 
compromise, suiting the needs of both management and the scientific assessment of medicinal 
products.  

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- Period of data protection for medicinal products authorised under the centralised procedure 
(amendments 12 and 62) : 

The amendments proposed by Parliament provide for the same period of data protection for 
products  authorised  under  the  centralised  procedure  whether  application  of  the  procedure  is 
compulsory  or  optional.  The  period  provided  for  is  eight  years  of  data  protection  and  two 
additional years of marketing protection. Products which refer to the data after the eight years 
of  protection  cannot  be  marketed  for  two  years  after  the  end  of  that  period.  Furthermore, 
medicinal products for which one or more new therapeutic indications of significant clinical 
benefit  compared  with  existing  therapies  are  authorised  during  the  eight-year  period  may 
receive one additional year of protection. 

Parliament also approved a new provision which will clarify the application over time of the 
provisions  concerning  data  protection.  These  new  periods  will  apply  only  for  reference 
medicinal products for which applications for authorisation are made after the date on which 
the  new  provisions  enter  into  force.  The  Commission  considers  this  provision  particularly 
important  in  the  context  of  the  new  Member  States,  which  have  to  bring  their  national 
provisions into line with the new legislation. 

-  Other  amendments  making  the  text  clearer  and  more  specific  and  strengthening  its 
provisions 

•  amendments  1,  41,  42  and  43  clarify  aspects  of  the  recitals  concerning  small  and 
medium—sized enterprises, tropical diseases, budgetary provisions and the application of 
patent law; 

•  amendments  11,  47,  48,  50,  52,  53,  55  and  37  strengthen  the  provisions  on  transparency 

and the general public’s access to documents; 

•  amendments 31, 32 and 33 make specific reference to the Committee on Herbal Medicinal 

Products; 

•  amendments 57 and 58 concern the databases and explain their content; 

•  amendments 8 and 18 concern the areas of competence of the scientific committee in the 
event of arbitration, amendment 45 the requirements for clinical trials carried out outside 
the Community, amendment 46 the duration of the analysis by the Committee, amendment 
49  and  amendment  54  the  frequency  of  PSURs  (periodic  safety  update  reports), 
amendment  51  the  file  to  be  submitted  for  the  five-year  renewal  and  amendment  61  the 
pharmacovigilance tasks of the agency and the communication networks. 

The Commission accepts these amendments, which do not alter the objective of the proposal 
but strengthen some of the existing provisions. 

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4.2.2  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 
and Directive amending Directive 2001/82/EC on the Community code relating to 
veterinary medicinal products. 

- Definitions (amendments 60, 61, 63, 65, 58 and 67 of the human code and 37, 39, 40, 35 and 
44 of the veterinary code): 

Parliament wished to amend the definitions of medicinal product, generic medicinal product 
and biosimilar medicinal product and to specify the conditions in which the definitions were 
applicable. It also specified the clause applicable in the case of borderline products, for which 
it is not possible precisely to determine which set of rules applies. 

In  the  Commission’s  view  these  amendments  clarify  the  provisions  concerned  and  are 
therefore acceptable. 

-  Period  of  data  protection  (amendments  14,  68  and  62  of  the  human  code  and  38  of  the 
veterinary code) :  

Parliament  adopted  amendments  to  bring  the  period  of  data  protection  into  line  with  the 
period  applicable  to  products  authorised  under  the  centralised  procedure  (see  above,  point 
4.2.1).  

- Information for patients (amendment 77): 

Parliament inserts a provision obliging the Commission to adopt a report on the situation in 
the  Community  regarding  the  information  provided  for  patients  on  medicinal  products 
available  on  prescription  only.  On  the  basis  of  that  report,  the  Commission  would  state 
whether  it  considers  it  appropriate  to  make  changes  to  the  current  rules  applicable  to  those 
products. 

The Commission accepts this amendment; future proposals on this subject will thus be based 
on facts and patients’ real needs regarding information. 

- Environmental impact of the  authorisation of medicinal products (amendments 56, 64, 57, 
75 and 84 of the human code and 34, 5, 43, 49 and 53 of the veterinary code) :  

Parliament  adopted  amendments  to  strengthen  obligations  regarding  the  assessment  of  the 
effects  on  the  environment  that  the  authorisation  of  medicinal  products  may  have  and  the 
measures to be taken to offset these effects. It also introduced a distinction between medicinal 
products for human use, for which the assessment of these effects cannot be included in the 
final assessment of the risk/benefit balance, and veterinary medicinal products, for which the 
assessment  of  these  effects  must  be  taken  into  account  when  the  risk/benefit  balance  of  the 
product is assessed.  

The Commission accepts these amendments, particularly because they respect the difference 
between the two types of medicinal product – those for human use and those for veterinary 
use.  

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-  Other  amendments  making  the  text  clearer  and  more  specific  and  strengthening  its 
provisions:  

•  as  regards  the  human  code,  the  Commission  accepts  amendment  66  on  clinical  trials, 
amendment  69  on  the  application  of  the  mutual  recognition  procedure  to  homeopathic 
medicinal  products,  amendment  70  on  assessment  deadlines,  amendment  25  on  the 
justification  for  approved 
indications,  amendment  72  on  conditional  marketing 
authorisations,  amendment  73  on  international  non-proprietary  names,  amendment  74  on 
the space to be provided on the packaging to indicate the prescribed dose, amendment 76 
on  information  in  Braille,  amendment  83  on  the  provision  regarding  continued  supplies, 
amendment  59  on  the  funds  earmarked  for  pharmacovigilance,  amendment  78  on  the 
frequency of PSURs (periodic safety update reports), amendments 79 and 80 bringing the 
text  into  line  with  the  regulation  concerning  tests  carried  out  by  an  Official  Medicines 
Control Laboratory and amendments 81 and 82 on transparency and public accessibility; 

the  prescribed  dose,  amendment  36  on 

•  as regards the veterinary code, the Commission accepts amendment 45 on the application 
of the mutual recognition procedure to homeopathic medicinal products, amendment 46 on 
assessment  deadlines,  amendment  48  on  the  space  to  be  provided  on  the  packaging  to 
indicate 
for 
pharmacovigilance,  amendment  54  on  the  frequency  of  PSURs  (periodic  safety  update 
reports), amendments 52 and 51 bringing the text into line with the regulation concerning 
tests  carried  out  by  an  Official  Medicines  Control  Laboratory,  amendments  41  and  42 
adding 
the 
identification  of  equidae  for  breeding  and  production,  amendment  11  concerning  the 
withdrawal  period  for  homeopathic  medicinal  products  intended  for  food-producing 
animals  the  active  substance  of  which  is  listed  in  Annex  II  to  Council  Regulation  (EC) 
No 2377/90 and amendment 47 concerning the documents to be submitted for the five-year 
renewal of marketing authorisations. 

the  full  reference  of  Commission  Decision  2000/68/EC  establishing 

funds  earmarked 

the 

The Commission accepts these amendments, which do not alter the objective of the proposal 
but strengthen some of the existing provisions. 

5. 

CONCLUSION 

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

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