Amended proposal for a COUNCIL REGULATION (EC) ON FEES PAYABLE TO THE EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS
Date: 1995-02-03
Institutions: European Commission
Subjects: European organisation, marketing standard, medicinal product, payment, pharmaceutical legislation, veterinary medicinal product

COMMISSION  OF  THE  EUROPEAN  COMMUNITIES 

COM(95) 27 final 
Brussels, 03.02.1995 

94/ 0220 (CNS) 

Amended  p r o p o s al 

f or  a 

COUNCIL  REGULATION  (EC) 

ON FEES PAYABLE TO THE EUROPEAN AGENCY 
FOR THE EVALUATION OF MEDICINAL PRODUCTS 

(presented  by  the  Commission  pursuant 
the  EC-Treaty) 

of 

to  A r t i c le  189  A  (2) 

EXPLANATORY  MEMORANDUM 

On  19 January  1995  the  European  Parliament  adopted  an opinion  on  the  proposal  for a 
Council  Regulation  on  the  fees  payable  to  the  European  Agency  for  the  Evaluation  of 
Medicinal Products. 

Four amendments to the Commission's original proposal were adopted on that occasion. 
The  Commission  agrees  to  incorporate  Amendment  2,  which  requires  that  forecasts  of 
fees  payable  the  following  financial  year  should  be  entered  in  the  annual  estimate 
adopted by the Agency's Management Board pursuant to Article 57(5) of Regulation  No 
2309/93. 

The Commission  agrees to  incorporate part of Amendment  1, namely  that any  surpluses 
in  the  Agency's  budget  should  accrue  to  the  Community  budget.  Accordingly,  the 
Commission proposes to include in the Regulation a provision stating that these surpluses 
shall  be deducted from the Community  contribution.  The Commission  also  proposes  to 
consider whether any surpluses could be used to repay previous subsidies. 

On the other hand, the Commission can not accept Amendments 3 and 4 requiring use  of 
the  procedure  defined  in  Article  189b  of  the  EC  Treaty  for  any  amendments  to  the 
Regulation, on the grounds that use of this procedure would not allow the amount of  fees 
to be  adjusted rapidly  in the  light of experience  and the actual  needs of  the  Agency.  In 
this  connection,  the  Commission  would  emphasize  the  temporary  nature  of  the 
Regulation  currently  under  discussion;  in  fact,  it  is  planning  to  come  up  with  a  new 
proposal in the course of  1997, on which Parliament will be consulted. 

^ 

AMENDED  PROPOSAL FOR A COUNCIL REGULATION (EC) 

ON FEES PAYABLE 
FOR THE EVALUATION 

TO THE EUROPEAN AGENCY 

OF MEDICINAL PRODUCTS 

Following  the  opinion  of  the  European 
following new Article is added to the 

Parliament  given  on  19 January  1995,  the 
Commission's original proposal (COM)(94) 0167): 

Article  lb 

The Agency  shall  enter,  in its 
draft  budget,  forecasts  of  fees 
from total estimated expenditure 

annual  estimate  for the Commission's  preliminary 
payable  the  following  financial  year  separately 
and any Community contribution. 

Any surpluses from fees shall be used to reduce the Community contribution. 

# 

ISSN 0254-1475 

COM(95) 27  final 

DOCUMENTS 

EN 

10  14 

Catalog number : CB-CO-95-034-EN-C 

ISBN 92-77-85254-2 

Office for Official Publications of the European Communities 

L-2985 Luxembourg 

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