Amended proposal for a Council Regulation (EC) amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicin al Products
Date: 1998-11-11
Institutions: European Commission
Subjects: European Medicines Agency, market approval, medicinal product, quasi-fiscal charge, veterinary medicinal product

10.2.1999

EN

Official  Journal  of  the  European  Communities

C  36/17

II

(Preparatory  Acts)

COMMISSION

Amended  proposal  for  a  Council  Regulation  (EC)  amending  Regulation  (EC)  No  297/95  on
fees  payable  to  the  European  Agency  for  the  evaluation  of  medicinal  products(cid:216)(˛)

(1999/C  36/09)

COM(1998)  648  final  -  98/0135(CNS)

(Submitted  by  the  Commission  pursuant  to  Article  189a(2)  of  the  EC  Treaty  on  12  November
1998)

(˛)(cid:217)OJ  C  22,  27.1.1999,  p.  11.

Following  the  opinion  of  the  European  Parliament  of  7  October  1998,  the  initial  Commission
proposal  (COM(1998)  21  final)  is  hereby  amended  as  follows:

ORIGINAL  TEXT

AMENDED  TEXT

Article  1,  point  2)

Article  3(2),  point  a),  single  subparagraph  a)  (new)  (Regulation  (EC)  No  297/95)

In  the  event  of  the  same  amendment  being  introduced,
this  fee  shall  cover  all  authorised  strengths,  pharma(cid:220)
ceutical  forms  and  presentations.

Article  3(2),  point  b),  single  subparagraph  a)  (new)  (Regulation  (EC)  No  297/95)

In  the  event  of  the  same  amendment  being  introduced,
this  fee  shall  cover  all  authorised  strengths,  pharma(cid:220)
ceutical  forms  and  presentations.

Article  5(2),  point  a),  single  subparagraph  a)  (new)  (Regulation  (EC)  No  297/95)

In  the  event  of  the  same  amendment  being  introduced,
this  fee  shall  cover  all  authorised  strengths,  pharma(cid:220)
ceutical  forms  and  presentations.

Article  5(2),  point  b),  third  subparagraph  (new)  (Regulation  (EC)  No  297/95)

In  the  event  of  the  same  amendment  being  introduced,
this  fee  shall  cover  all  authorised  strengths,  pharma(cid:220)
ceutical  forms  and  presentations.

C  36/18

EN

Official  Journal  of  the  European  Communities

10.2.1999

ORIGINAL  TEXT

AMENDED  TEXT

Article  6,  second  subparagraph  (Regulation  (EC)  No  297/95)

This  fee  shall  be  increased  by  ECU  15(cid:216)000  where  the
procedures  laid  down  in  Articles  19  and  20  of  Directive
81/851/EEC  are 
instigation  of  the
initiated  at  the 
applicant  for  or  holder  of  the  marketing  authorisation.

This  fee  shall  be  increased  by  ECU  20(cid:216)000  where  the
procedures  laid  down  in  Articles  19  and  20  of  Directive
81/851/EEC  are 
instigation  of  the
initiated  at  the 
applicant  for  or  holder  of  the  marketing  authorisation.

Article  7(1),  second  subparagraph  (Regulation  (EC)  No  297/95)

An  additional  MRL  fee  of  ECU  10(cid:216)000  shall  be  payable
for  each  application  to  amend  or  extend  an  existing
MRL,  including  to  cover  new  species.

An  additional  MRL  fee  of  ECU  15(cid:216)000  shall  be  payable
for  each  application  to  amend  or  extend  an  existing
MRL,  or  to  cover  new  species.

Article  8,  point  1  (Regulation  (EC)  No  297/95)

This  fee  shall  be  charged  where  an  application  is  made
for  scientific  or  technical  advice  concerning  a  medicinal
product  before  an  application  is  submitted  for  autho(cid:220)
risation  to  market  it.

This  fee  shall  be  charged  where  an  application  is  made
for  scientific  or  technical  advice  concerning  a  medicinal
product  before  an  application  is  submitted  for  autho(cid:220)
risation  to  market  it.

-(cid:217)For  medicinal  products  for  human  use  the  fee  is  set

-(cid:217)For  medicinal  products  for  human  use  the  maximum

at  ECU  60(cid:216)000.

fee  is  set  at  ECU  60(cid:216)000.

-(cid:217)For  medicinal  products  for  veterinary  use  the  fee  is

-(cid:217)For  medicinal  products 

for  veterinary  use 

the

set  at  ECU  30(cid:216)000.

maximum  fee  is  set  at  ECU  30(cid:216)000.

The  implementing  rules  for  this  Article  shall  be  adopted
under  the  procedure  laid  down  in  Article  11(2).

Article  12,  third  subparagraph  a)  (new)  (Regulation  (EC)  297/95)

Future  reviews  of  fees  shall  be  based  on  a  full  cost
evaluation  of  the  costs  of  the  Agency,  including  expen(cid:220)
diture  relating  to  Member  States’  rapporteurs.