Proposal for a Council Regulation (EC) amending Council Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products
Date: 1998-01-21
Institutions: European Commission
Subjects: European Medicines Agency, market approval, medicinal product, payment, veterinary medicinal product

"vw<M6i$(tij&* 

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels,  21.01.1998 
COM(1998) 21 final 

PROPOSAL FOR A COUNCIL REGULATION (EC) AMENDING COUNCIL 
REGULATION (EC) No 297/95  ON FEES PAYABLE TO THE EUROPEAN 
AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS 

(presented by the  Commission) 

Explanatory  memorandum 

Introduction: 

Pursuant to Council  Regulation  (EEC) No 2309/93 of 22 July  1993  laying down Community 
procedures  for  the  authorisation  and  supervision  of  medicinal  products  for  human  and 
veterinary  use and establishing  a European  Agency  for the Evaluation  of Medicinal  Products 
("the  EMEA"),  the  Council  establishes  the  structure  and  the  amount  of  fees  paid  by 
undertakings  for  obtaining  and  maintaining  a  Community  marketing  authorisation  and  for 
other services provided  for by the EMEA. 

The current  level and  structure  of fees  payable  by the  pharmaceutical  industry to the  EMEA 
vvas set out  in Council  Regulation  (EC) No 297/95" adopted  on  10 February  1995. Article  10 
of this  Regulation  provides  that  the Commission  shall  submit a report  on  its implementation 
and,  in  the  light  of  that  experience,  propose  a  defmitive  Regulation  to  the  Council.  The 
Council, acting  by a qualified  majority  after  consulting the European  Parliament,  shall  adopt 
provisions on the amounts of the fees  and  the conditions governing them, to apply as from  1 
January  1998. 

It  was  acknovvledged  by  Council  in  1995  that  the  level  of  fees  provisionally  adopted  vvas a 
temporary  arrangement  during  the  transition  period  (1995 to  1997). They were not  intended 
to  fully  cover  the  costs  associated  vvith  the  EMEA.  Fee  revenue  is  eomplcmented  by  a 
substantial  contribution  from  the  EU general  budget,  in particular  to cover the start-up  costs 
for  the  Agency. The  structure  of  EMEA  fees  was  deliberately  kept  simplc  and,  in  line vvith 
orientations  from  Council,  this  vvas also  to  be  re-examined  along  vvith  the  fee  levels  in  the 
light of experience. 

In preparing this proposal  the Commission  has sought  to ensure  to maintain the dual  aims  of 
not  placing  an  undue  burden  on  applicants  and  not  endangering  the  achievement  of  the 
EMEA's primary task of providing scientific  advice of the highest possible quality  in relation 
to the authorisation  and supervision  of medicinal  products. 

The level of fees proposed  by the Commission  are comparable to the levels put  forward  in  its 
initial  proposal  for  Council  Regulation  (EC) No 297/95  (see  COM(94)  167 final, 27.05.94). 
These  figures  were  later substantially  reduced  during  the decision-taking  procedure.  Despite 
EU  budgetary  difficulties, 
it  is  expected  that  there  will  be  a  continuing  need  for  a 
contribution  from  the Community,  in  particular  to guarantee  the  independence  of the  EMEA 
vvith regard  to the  sector  in which  it operates. This  independence  will  be  further  ensured  by 
the  introduction  of  an  annual  fee,  which  is  of  a  global  nature  and  vvill  therefore  balance 
revenue from  fees for services received  from  individual companies. 

'OJL 214, 24.08.1993, p.l 
"OJL35,  15.02.1995, p.l 

Expcriencc with thc implementation of Regulation (EC) No 297/95: 

The  EMEA  was  invited  by  the  European  Commission  to  make  a  contribution  to  the 
preparation  of this report based on  its experience of the implementation  of the Regulation. 

A  survey  vvas carried  out  by  the  EMEA  on  the  costs  of  national  competent authorities  and 
the  EMEA Secretariat associated  with the operation  of the centralised procedure. 

The basic fmdings endorsed  by the EMEA Management Board are: 

•  The  current  fee  level  does  not  cover  the  real  costs  incurred  by  either  the 
national  competent  authorities  or  the  Agency  and  vvould  therefore  have  to  be 
increased 

•  The  majority  of  EMEA  revenue  should  derive  from  fees,  with  a  certain 
proportion  of  revenue  continuing  to  come  from  the  EU  budget;  this  vvould 
permit the EMEA to pursue EU policies of general  interest 

•  The  current  fee  structure  should  be  revised  to  introduce  an  annual  fee  for  the 
funding  of  post-authorisation  maintenance  activities.  Given  the  resource 
implications  of  scientific  advice,  a  specific  fee  for  that  service  should  also  be 
introduced 

•  A  range  of  fees,  as  opposed  to  fixed  fees,  might  be  introduced  to  take  into 
account the complexity and vvorkload related to certain types of applications 

The results of the survey shovved that the average cost for national competent authorities vvho 
had  acted  as  rapporteur  or  co-rapporteur  in  the «evaluation  of  centralised  applications  for 
medicines for human use vvas ECU 78  130. 

The  costs  of  the  EMEA  Secretariat  vvere  calculated  at  ECU  188  710  per  application. 
Different  alternative  analytical  accounting  methocls  applied  sinee  the  completion  oi'  the 
EMEA report have confirmed  the magnitude of these costs. 

It appeared  that  the evaluation  costs  of veterinary  medicinal  products  are similar  to those  of 
medicines  for  human  use  on  the  basis  of  the  actual  vvorkload  required  for  the  applications. 
The EMEA Management  Board therefore  called  for a convergence of fee  levels between  both 
scctors for activities such as applications for  marketing authorisations and arbitrations. 

Presentation of the proposal: 

The  fee  levels proposed  by the Commission  are designed  to permit the  EMEA to continue to 
meet  the  high  scientific  and  organisational  standards  required  by Council  Regulation  (EEC) 
No 2309/93. 

} EMEA report Contribution to the preparation  ofa  Commission proposal for  a tlefinitive 
Council Regulation onfees  payable  to the EMEA,  EMEA/MB/057/96.Public 

1 

As  a  general  principle,  fees  for  obtaining  Community  marketing  authorisations  in  the 
centralised  procedure  should  be  comparable  to  the  benefit  derived  from  a  single  procedure 
and  authorisation  throughout  the  Community.  It should  therefore  be more or  less  equivalent 
to but  in no case substantially  higher than the total of fees charged by the  15 Member States4. 

The  basic  full  fee for  the evaluation  of an  application  for  medicinal  products  for  human  use 
is proposed  at ECU 200 000 - the same  level  as put forvvard  by the Commission  in  its  initial 
proposal  for the current  fee  Regulation (COM(94)  167 final, 27.05.94). 

This  increase  in  fee  level  is  clearly  demonstrated  and  supported  by  the  cost  survey  of  the 
national competent authorities and the EMEA. 

The Commissioifs  proposal  foresees  three major  nevv orientations. 

Firstly,  the  experience  of  the  EMEA  has  shown  that  certain  variations  of  major  importancc 
("type  II  variations') do not  necessarily  involve  detailed  scientific  evaluation.  It  is  therefore 
proposed  that  the  possibility  should  be  introduced  to permit the EMEA Management  Board, 
on  a proposal  of  the  Executive  Director,  to  determine  those  cases  in which  the  fee  payable 
for a type II variation  may be halved. 

The second  initiative  is the  introduction  of an annual  fee  vvhich  is destined  to meet the  costs 
associated  vvith the supervision  and maintenance of medicinal  products granted a Community 
important  part  of  the 
marketing  authorisation.  These  activities  are  an 
responsibilities  of  all  regulatory  authorities.  They  also  dravv  heavily  on  the  resources  of 
competent authorities since they are carried out continuously throughout the life of a product. 

increasingly 

The introduction  of an annual  fee as proposed  by thc Commission  is in linc v\ith the practiccs 
of  many  national  competent  authorities.  According  to  information  submitted  to  the  EMEA 
Sccretariat,  annual  fees  are  in  fact  levied  by  national  competent  authorities  in  11 of  the  15 
Member  States  (all  Member  States  except  Belgium,  Germany,  Austria  and  Italy).  Levels  of 
annual  fees  vary considerably  between  national  authorities,  from  ECU  13 in Luxembourg to 
a sales-based  fee  potentially  exceeding  ECU 21 000  levied  by the UK Yeterinary  Medicines 
Directorate.  As  the  EMEA  moves to  increasing  reliance  on  revenue  from  fees,  annual  fees 
vvill contribute  to the stability  of financial  planning. A part of the annual  fee vvill have to  be 
redistributed  to Member States to cover the costs of market supervision  undertaken  on  behalf 
of the Community. The  rules for  distribution  among  Member  States will have to be  adopted 
by the Agency's Management  Board. 

Thirdlv,  the  proposal  also  provides  for  the  introduction  of  a  fee  for  scientific  advice  and 
protocol  assistance given to future  applicants  in the design of their research and  development 
programmes.  The  experience  of  the  EMEA  has  shown  that  this  service  can  demand 
considerable  scientific  and  resource  input.  From  the  perspective  of  future  applicants,  the 
provision  of scientific  advice on matters to which  no alternative  guidance  is readily  available 
can  be  of  considerable  advantage  in  reducing  questions  raised  by  the  EMEA  during 
evaluation of an application  for marketing authorisations. 

4 Account should also be taken of the fact that under the EEA-Treaty, the scope of application of a 
central marketing authorisation vvill possibly be extended to Norway, Iceland and - under specific 
circumstances - also to Liechtenstein. 

New  provisions  also  include  initiatives  for  a  fee  for  the  establishment of  maximum  residue 
limits  ('MRLs')  for  clinical 
introduction  of 
differentiated  fees  for  the  initiation  of  Community  referral  procedures  under  Council 
Directives 75/319/EEC and  81/851/EEC. 

trials,  administrative  charges  and  the 

' In spite of the EMEA's  Finding that the evaluation  costs of veterinary  medicinal products  are 
similar to those of medicines  for  human  use  it vvas decided  to take account of the  specificity 
of  the  market  of  veterinary  medicinal  products  and  the  public  and  animal  health  issues 
involved and to maintain  the reduced  fees for veterinary medicinal  products 

In  accordance  with  Article  58  of  Regulation  (EEC)  No  2309/93,  a  draft  of  the  present 
proposal  was  forwarded  to  organisations  representing  the  interests  of  the  pharmaceutical 
industry  at  Community  level.  The  Commission  carefully  examined  and  considered  ali 
comments received  before  submitting the present proposal. 

The  evolution  of  fees  from  Council  Regulation  (EC) No  297/95  and  the  current  proposal  is 
shovvn in the following comparative table: 

Fees  for  medicinal  products  for  human  use 

Full fee 

Reduced  fee 

Council  Regulation  (EC) 
No  297/95 

ECU  140 000 to 200 000 
(add ECU 20 000 for additional 
strength and'or pharmaceutical 
forms) 

ECU 70 000 to  100 000 
(add  ECU  10 000  for additional 
strength  and'or  pharmaceutical 
forms) 

Extension  fee 

ECU 40 000 

Type  I variation 

Type II variation 

ECU 5 000 

ECU 40 000 

Five year renewal fee 

Inspection  fee 

ECU  10 000 

ECU  10 000 

Transfer  of MA holder fee 

ECU 5 000 

Arbitration  fee 

ECU 30 000 

Annual  fee 

Fee for scientific  advice 

n/a 

n/a 

Commission  proposal 

ECU 200 00Q 
(add ECU 20 000 for  additional 
strength and/or  pharmaceutical 
forms and ECU 5 000 for each 
additional  presentation) 

ECU  100 000 
(add  ECU 20 000  for  additional 
strength and'or  pharmaceutical 
forms and ECU 5 000  for each 
additional  presentation) 

ECU 50 000 for new strength, 
pharmaceutical  form  or indication 

ECU  10 000 for new  presentation 
of a strength and form  already 
authorised 

ECU 5 000 

ECU 60 000 
(possible reduction  by half  for 
specific  type II applications) 

ECU  10 000 

ECU  15  000 

ECU 5 000 

ECU  10 000 where referral  made 
by national authorities or 
Commission 

ECU 50 000 where referral  made 
by applicant or MA holder 

ECU 60 000 

ECU 60 000 

Fees  for  medicinal  products  for  veterinary  use' 

Full fee 

Reduced fee 

Council  Regulation  (EC) 
No  297/95 

. 

ECU 70 000 to  100 000 
(add ECU  10 000 for additional 
strength and/or  pharmaceutical 
forms) 

ECU 35 000 to 50 000 
(add ECU  5 000 for additional 
strength  and'or  pharmaceutical 
forms) 

Extension  fee 

ECU 20 000 

Type  I variation 

Type II variation 

ECU 5 000 

ECU 20 000 

Commission  proposal 

ECU  100 000 
(add  ECU  10 000 for  additional 
strength and/or  pharmaceutical 
forms  and  ECU 5 000  for  each 
additional  presentation) 

ECU 50 000 
(add ECU  10 000 for  additional 
strength and/or  pharmaceutical 
forms and  ECU 5 000  for  each 
additional  presentation) 

ECU 25 000 for new  strength, 
pharmaceutical  form  or  indication 

ECU 5 000 for new  presentation 
of a strength and form  already 
authorised 

ECU 5 000 

ECU 30 000 
(possible reduction  by half  for 
specific  type II applications) 

Maximum residue limit (MRL) 
fee 

ECU 40 000 

ECU 50 000 

Modification  or extension of an 

ECU  10 000 

ECU  10 000 

existing MRL 

MRL for clinical trials 

n/a 

Five year renewal fee 

Inspection  fee 

ECU 5 000 

ECU  10 000 

Transfer  of MA holder fee 

ECU 5 000 

Arbitration  fee 

ECU  15 000 

Annual  fee 

Fee for scientific  advice 

n/a 

n'a 

ECU  15 000 

ECU 5 000 

ECU  15 000 

ECU 5 000 

ECU  10 000 where referral  made 
by national  authorities or 
Commission 
ECU 25 000 where referral  made 
by applicant or MA  holder 

' 

ECU 30 000 

ECU 30 000 

The Commission proposal provides for a reduction  by half for applications  for marketing 
authorisations for veterinary vaccines (i.e. full  fee of ECU 50 000), type II variations are subject  to 
afeeofECUSOOO. 

PROPOSAL FOR A COUNCEL REGULATION (EC) AMENDING COUNCIL 
REGULATION (EC) No 297/95 ON FEES PAYABLE TO THE EUROPEAN 
AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, 

Having  regard  to  Council  Regulation  (EC)  No  297/95  of  10  February  1995  on  fees 
payable to  the  European  Agency  for  the  Evaluation  of Medicinal  Products!  (hereinafter 
referred to as 'the Agency'), and in particular Article  10 thereof, 

Having regard to the proposal from the Commission,2 

Whereas under Article  57(1)  of  Council  Regulation  No 2309/93  of  22  July  1993  laying 
down Community procedures for the authorisation and supervision of medicinal  products 
for  human and veterinary  use  and establishing  a European  Agency  for the  Evaluation  of 
Medicinal  Products,3  the revenues  of the  Agency  consist  of  a contribution  and the  fees 
paid by undertakings for obtaining and maintaining a Community marketing authorisation 
and for other services provided by the Agency; 

Whereas the amounts and structure of the fees established by Regulation (EC) No 297/95 
must be reviewed before 31 December 1997; 

Whereas  in  view  of  the  experience  gained  since  1995  it  is  appropriate  to  maintain the 
general  principles  and  overall  structure  of  the  fees  as well  as  the  main  operational  and 
procedural provisions established by the abovementioned Regulation; 

Whereas for certain fees,  however, the services they relate to should be specified  so as to 
facilitate  their  collection  and  improve  the  transparency  and  practical  implementation  of 
this Regulation; 

Whereas new fees must also be established  to cover all the services now provided by the 
Agency; 

Whcreas an annual fee must be introduced to cnsure coverage of the costs connccted with 
the supervision of authorised medicinal products; whereas a given part of this fee will have 
to go to the competent national authorities required under the terms of Regulation (EEC) 
No 2309/93 to supervise the market on bchalf of the Community; whereas, moreover, the 
rules for  distribution  among  those  authorities  will  have  to  be  adopted  by  the  Agency's 
Management Board in accordance with the procedure laid down in this Regulation; 

lOJL35,  15.02.95. p. 1. 

2 

3 OJL 214, 24.08.93. p. 1. 

Whereas,  in  certain  exceptional  cases  and  for  imperative  reasons  of  public  or  animal 
health, it must be possible to reduce the abovementioned  fees; whereas, therefore,  without 
prejudice to more specific  provisions of Community  law, any decision to reduce  fees will 
have to  be taken  by the Executive  Director  on the  basis  of  a critical  examination  of  the 
situation specific to each case after consultation of the competent scientific committee, 

HAS ADOPTED THIS REGULATION: 

Article 1 

Regulation (EC) No 297/95 is hereby amended as follows: 

1. Article 1  is replaced by the following  text: 

"Article 1 

Scope 

Fees for obtaining and maintaining a Community authorisation to market medicinal 
products for  human and veterinary  use  and  for  the  other  services  supplied  by  the 
Agency shall be levied in accordance with this Regulation. 

The amounts of these fees shall be Iaid down in ecus." 

2. Articles 3 to  11 are replaced by the following  text: 

"Article 3 

Medicinal  products  for  human  use  covered  by  the  procedures  laid  down  tn  Council 
Regulation (EECi No 2309/93 

(1)  Authorisation to market a medicinal product 

(a)  Fullfee 

The fee for  an application  for  authorisation  to  market  a medicinal product  supported 
by  a full  dossier  is ECU  200  000.  It  covers  only  one  presentation  of  the  medicinal 
product (for one strength associated with one pharmaceutical form). 

The  fee  shall  be  increased  by  ECU  20  000  for  each  additional  strength  and/or 
pharmaceutical  form  submitted  at  the  same  time  as  the  initial  application  for 
authorisation.  This  increase  covers  only  one  presentation  of  the  additiona!  strength 
and/or pharmaceutical  form. 

The fee shall be increased by ECU 5 000 for  each  additional presentation  of the  same 
strength and pharmaceutical form,  submitted at the same time as the initial  application 
for  authorisation. 

(b)  Reduced  fee 

-8-

A reduced fee of ECU 100 000 shall apply to applications for authorisation to market 
a medicinal product for which a full dossier need not be presented, as provided for in 
Article 4  point  8(a)(i)  and (iii)  of Directive  65/65/EEC  or when  recourse  is  had to 
Article 4 point  8 (a)(ii)  of the same Directive.  This fee  covers  a single  presentation 
(for one strength associated with one pharmaceutical form). 

The  fee  shall  be  increased  by  ECU 20 000  for  each  additional  strength  and/or 
pharmaceutical  form  submitted  at  the  same  time  as  the  initial  application  for 
authorisation.  This  increase  covers  only  one  presentation  of  the  additional  strength 
and/or pharmaceutical form. 

The fee shall be increased by ECU 5 000 for each additional presentation of the same 
strength and pharmaceutical form, submitted at the same time as the initial application 
for authorisation. 

(c)  Extension fee 

This is the fee for each extension of a marketing authorisation which has already been 
granted: 

- where  the  extension  is  for  a  new  strength,  a new  pharmaceutical  form  or  a new 
indication, the fee is ECU 50 000; 

- where  the  extension  is for  a new  presentation  of  a strength  and a pharmaceutical 
form which are already authorised, the fee is ECU 10 000. 

(2)  Variation 

(a)  Type I variation fee 

The fee for a variation of minor importance to a marketing authorisation according to 
the classification established by the Commission Regulation applicable to the matter is 
ECU 5 000. 

(b)  Type II variation fee 

The fee for a variation of major importance to a marketing authorisation according to 
the classification established by the Commission Regulation applicable to the matter is 
ECU 60 000.  It may be halved  for  certain  Type II variations which  do  not  involve 
detailed scientific evaluation, a list of which shall be drawn up in accordance with the 
procedure laid down in Article  11(2) of this Regulation. 

(3)  Renewal fee 

The fee for examining information  available at the time of the five-yearly  renewal  of 
an authorisation to  market a medicinal  product  is ECU 10 000.  It  shall  be charged 
for each strength associated with a pharmaceutical form. 

(4)  Inspection fee 

i 

The flat-rate fee for any inspection within or outside the Community is ECU  15 000. 
For inspections outside the Community, travel expenses will be charged extra on the 
basis ofactual cost. 

(5)  Transferfee 

The  fee  for  a  change  in  the  holder  of  the  marketing  authorisations  to  which  the 
transfer  relates  is  ECU 5 000.  This  covers  all  presentations  of  a  given  medicinal 
product. 

(6)  Annualfee 

The  annual  fee  for  each  medicinal  product  which  has  been  granted  a  marketing 
authorisation  is  ECU 60 000.  This  covers  all  authorised  presentations  of  a  given 
medicinal product. 

Article 4 

Medicinal  products  for  human  use  covered  bv  the  procedures  laid  down  in  Council 
Directive75/319/EEC.4 

An  arbitration  fee  of  ECU 10 000  shall  be  payable  where  the  procedures  laid  down  in 
Articles  10(2),  11,  12 and 15 ofDirective  75/319/EEC are initiated. 

The fee shall be increased by ECU 40 000 where the procedures laid down in Articles 11 
and  12  ofDirective  75/319/EEC  are  initiated  at  the  instigation  of  the  applicant  for  or 
holder of the marketing authorisation. 

Article 5 

Medicinal  products  for  veterinary  use  covered  by  the  procedures  laid  down  in  Council 
Regulation (EEO No 2309/93 

(1)  Authorisation to market a medicinal product 

(a)  Fullfee 

The fee for an application for authorisation to market a medicinal product supported 
by  a full  dossier  is ECU 100 000.  It  covers  only  one  presentation  of  the  medicinal 
product (for one strength associated with one pharmaceutical form). 

The  fee  shall  be  increased  by  ECU 10 000  for  each  additional  strength  and/or 
pharmaceutical  form  submitted  at  the  same  time  as  the  initial  application  for 
authorisation.  This  increase  covers  only  one  presentation  of  the  additional  strength 
and/or pharmaceutical form. 

4  OJ L 147, 9.6.1975, p.  13. Directive last amendcd by Dircctive 93/39/EEC (OJ L 214, 24.8.1993, p. 22). 

to 

The fee shall be increased by ECU 5 000 for each additional presentation of the same 
strength and pharmaceutical form, submitted at the same time as the initial application 
for authorisation. 

In the case of vaccines,  the full  fee  is reduced to ECU 50 000, with each additional 
strength  and/or  pharmaceutical  form  and/or  presentation  entailing  an  increase  of 
ECU 5 000. 

For the purposes of this paragraph, the number of target species is irrelevant. 

(b)  Reduced fee 

A reduced fee of ECU 50 000 shall apply to applications for authorisation to market a 
medicinal  product  for which a full  dossier need not be presented,  as provided  for in 
Article 5 point  10(a)(i) and (iii) of Directive  81/851/EEC or when recourse is had to 
Article 5 point  10 (a)(ii) of the same Directive. This fee  covers a single presentation 
(for one strength associated with one pharmaceutical form of the medicinal product). 

The  fee  shall  be  increased  by  ECU  10 000  for  each  additional  strength  and/or 
pharmaceutical  form  submitted  at  the  same  time  as  the  initial  application  for 
authorisation.  This  increase  covers  only  one  presentation  of  the  additional  strength 
and/or pharmaceutical form. 

The fee shall be increased by ECU 5 000 for each additional presentation of the same 
strength and pharmaceutical form, submitted at the same time as the initial application 
for authorisation. 

In  the  case  of  vaccines,  the  fee  is  reduced  to  ECU 25 000,  with  each  additional 
strength  and/or  pharmaceutical  form  and/or  presentation  entailing  an  increase  of 
ECU 5 000. 

For the purposes of this paragraph, the number of target species is irrelevant. 

(c)  Extension fee 

This is the fee for each extension of a marketing authorisation which has already been 
granted: 

- where  the  extension  is  for  a new  strength,  a new  pharmaceutical  form  or  a new 
species, the fee is ECU 25 000; 

- where  the  extension  is for  a new  presentation  of  a strength  and a pharmaceutical 
form which are already authorised, the fee is ECU 5 000; 

-  in  the  case  of  vaccines,  where  the  extension  is  for  a  new  strength,  a  new 
pharmaceutical form or a new presentation, the fee is ECU 5 000. 

(2)  Variation 

(a)  Type I variation fee 

11 

The fee for a variation of minor importance to a marketing authorisation according to 
the classification established by the Commission Regulation applicable to the matter is 
ECU 5 000. The same fee is charged in respect of vaccines. 

(b)  Type II variation fee 

The fee for a variation of major importance to a marketing authorisation according to 
the classification established by the Commission Regulation applicable to the matter is 
ECU 30 000.  It may be halved  for  certain Type II variations which  do  not  involve 
detailed scientific evaluation, a list of which shall be drawn up in accordance with the 
procedure laid down in Article 11(2) of this Regulation. 

In the case of vaccines, the fee is ECU 5 000. 

(3)  Renewalfee 

The fee for examining available information  at the time of the five-yearly  renewal  of 
an authorisation to market a medicinal product is ECU 5 000.  It shall be charged for 
each strength associated with a pharmaceutical form. 

(4)  Inspection fee 

The flat-rate fee for any inspection within or outside the Community is ECU  15 000. 
For inspections outside the Community, travel expenses will be charged extra on the 
basis of actual cost. 

(5)  Transferfee 

The  fee  for  a  change  in  the  holder  of  the  marketing  authorisations  to  which  the 
transfer  relates  is  ECU 5 000.  This  covers  all  presentations  of  a  given  medicinal 
product. 

(6)  Annual fee 

The  annual  fee  for  each  medicinal  product  which  has  been  granted  a  marketing 
authorisation  is  ECU 30 000.  This  covers  all  authorised  presentations  of  a  given 
medicinal product. 

Article 6 

Medicinal  products  for  veterinary  use  covered  by  the  procedures  laid  down  in  Council 
Directive81/851/EEC5 

Arbitration fee 

An  arbitration  fee  of  ECU  10 000  shall  be  payable  where  the  procedures  laid  down  in 
Articles 18(2),  19, 20 and 23 of Directive 81/851/EEC are initiated. 

5 OJ L 147, 9.6.1975, p. 13. Dircctivc lasl amcndcd by Dircctivc 93/39/EEC (OJ L 214, 24.8.1993, p. 22). 

l2 

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

Article 7 

Establishment of maximum residue limits (MRD for veterinarv medicinal products 

(1)  Fees for establishing MRL 

A full  MRL fee  of ECU 50 000  shall be  charged for  an application to  set  an initial 
MRL for a given substance. 

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

MRL  fees  will  be  deducted  from  the  fee  payable  for  an  application  for  marketing 
authorisation or an application to extend  a marketing authorisation for the medicinal 
product  containing  the  substance  for  which  a  MRL  has  been  set  where  such 
applications are submitted by the same applicant.  However,  this deduction  may total 
no more than one half of the fee to which it applies. 

(2)  'Maximum residue limit for clinical trials' fee 

A fee of ECU 15 000  shall be charged for any application to set a MRL with a view 
to clinical trials. 

The fee will be deducted from the amount of the full MRL fee laid down in point  1 of 
this Article. 

Article 8 

Various fees 

(1)  Fee for scientific advice 

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 
authorisation to market it. 

- For medicinal products for human use the fee is set at ECU 60 000. 
- For medicinal products for veterinary use the fee is set at ECU 30 000. 

(2)  Fees for administrative charges 

Fees  shall be payable for  administrative  charges when  documents  or certificates  are 
issued outside the framework of services covered by another fee provided for  in this 
Regulation  or upon conclusion  of the administrative validation  of a dossier resulting 
in rejection of the application for which the dossier was  submitted. The unit amount 
of  such  fees  may  not  exceed  ECU 5 000.  In  accordance  with  Article 11(2)  of  this 
Regulation,  a  classification  shall  be  established  and  specified  by  the  Management 
Board. 

Article 9 

Possible fee reductions 

Without  prejudice  to  more  specific  provisions  of  Community  law,  in  exceptional 
circumstances and for imperative reasons of public or animal health, fee reductions may be 
granted  case  by  case  by  the  Executive  Director  after  consultation  of  the  competent 
scientific  committee.  Any  decision  taken  in  application  of  this  Article  shall  state  the 
reasons on which it is based. 

Article 10 

Due date and belated payment 

(1)  Fees shall be payable on the date of receipt of the relevant application unless  specific 

provisions stipulate otherwise. 

The arbitration fee  shall be payable within 30  days following  referral  to the Agency; 
the  annual  fee  shall  be  payable  within  30  days  following  the  anniversary  of  the 
notification of the marketing authorisation decision. 

The inspection fee shall be payable at the latest within 30 days following  the date on 
which the inspection was carried out. 

(2)  Where  any  fee  payable  under  this  Regulation  remains  unpaid  at  its  due  date,  and 
without prejudice to the Agency's capacity to institute legal proceedings conferred on 
it by Article 59 of Council Regulation  (EEC) No 2309/93, the Executive Director  of 
the Agency may decide either not to provide the requested  services or to  suspend all 
the  services  and procedures  under way  until  the whole  of the relevant  fee  has  been 
paid. 

(3)  Fees  shall be  paid  in ecus  or in the  national  currency  of  one of  the Member  States 
according  to  the  exchange  rates  in  force,  which  shall  be  fixed  daily  by  the 
Commission.  However,  monthly  conversion  rates  based  on the earlier  rates  may  be 
fixed according to a calculation established by the Agency's Management Board. 

Article 11 

Implementing rules 

(1)  On a proposal  from the Executive Director and following  a favourable  opinion  from 
the Commission,  the Agency's  Management  Board  shall  fix the rules for  repaying a 
part  of  the  resources  deriving  from  the  annual  fees  to  the  competent  national 
authorities involved in Community market supervision. 

(2)  Without  prejudice -to  the  provisions  of  this  Regulation  or  of  Regulation  (EEC) 
No 2309/93,  the  Agency's  Management  Board  may,  on  a  proposal  from  the 
Executive Director,  specify  any other provision proving necessary for the application 
of this Regulation. 

i* 

(3)  In the event of disagreement as to the classification of an application in one of the fee 
categories  laid  down  in this  Regulation,  the  Executive  Director  shall  give  a ruling 
after consultation of the competent scientific committee. 

Article 12 

Amendment 

Any amendment to this Regulation  shall be adopted by the Council  acting by a qualified 
majority after consulting the European Parliament. 

However,  amendments to the amounts of the fees  established by this Regulation  shall be 
adopted  in accordance with the  procedure  laid  down  in Article 73  of Regulation  (EEC) 
No 2309/93. 

Within five years of the entry into force of this Regulation, the Commission shall present a 
report on its implementation, after consultation of the Agency's Management Board." 

Entry into force 

Article 2 

This Regulation  shall  enter into  force  on the  day following  its publication  in the offwial 
Journal ofthe European Commimities. 

This  Regulation  shall  be  binding  in  its  entirety  and  directly  applicable  in  all  Member 
States. 

Done at Brussels, 

tb 

FINANCIAL  STATEMENT 

1. 

TITLE OF OPERATION 

Proposal  for  a Council  Regulation  on  fees  payable  to the  European  Agency  for the  Evaluation 
of Medicinal  Products. 

2. 

BUDGET HEADING  INVOLVED 

-  European Community contribution  B5-3  1  2 0 

-  EMEA  own  budget  (see,  e.g.,  EMEA  statement  of  revenue  and  expenditure  for  financial 

year  1997, OJ No L.79 of 20 March  1997, page 31) 

3. 

LEGAL BASIS 

Articies 57 and 58 of Council  Regulation  (EEC) No 2309/93 of 22 July 1993. 

The  presentation  of this second  Regulation  is provided  for  in Article  10 of Council  Regulation 
(EC)  No  297/95  of  10  February  1995  on  fees  payable  to  the  European  Agency  for  the 
Evaluation  of Medicinal  Products. 

4. 

DESCRIPTION OF OPERATION 

4.1 

General objective 

-  Completion  of  the  internal  market  in  the  pharmaceuticals  sector  (medicinal  products  for 

human and veterinary use). 

-  Contribute  to  protection  and  promotion  of  public  and  animal  health  and  consumer 

protection  through: 

- 

- 

- 

a  European  system  for  the  centralised  evaluation  and  authorisation  oi~ 
biotechnology-derived and other  innovative medicinal products; 

limiting risks of veterinary  medicine residues in food-producing  animals; 

an  arbitration  mechanism  vvhere  Member  States  are  unable  to  agree  on  the 
mutual recognition  of national  marketing authorisations; and 

- 

a Europe-wide system  for the surveillance of safety of medicines. 

ic 

4.2 

Speciflc objectives 

Council  Regulation  (EEC)  No  2309/93  of  22  July  1993  lays  dovvn  (centralised)  Community 
procedures  for  the  authorisation  and  supervision  of  medicinal  products  for  human  and 
veterinary  use  and  establishes  a  European  Agency  for  the  Evaluation  of  Medicinal  Products 
("EMEAV).  Three  Council  Directives  (93/39/EEC,  93/40/EEC  and  93/41/EEC)  complete  the 
system  fqr the authorisation  of medicinal  products under the decentralised  (mutual  recognition) 
procedure. 

Article  57(1)  of  Council  Regulation  2309/93  provides  that  the  resources  of  the  EMEA  shall 
consist  of: 

- 
- 

a contribution from  the Community, and 
fees paid by undertakings for obtaining and maintaining a Community marketing 
authorisation  and for other services provided  by the EMEA 

Council  Regulation  (EC)  No  297/95  was  adopted  to  implement  a  structure  and  level  of  fees 
payable to the EMEA. 

This  proposal  is  presented  in  accordance  vvith  Article  10  of  that  Regulation  under  which 
Council,  in  consultation  with  Parliament,  is  required  to  adopt  further  provisions  to  apply  as 
from  I  January  1998  on  the  basis  of  practical  experiencc  of  the  implemcntation  oi'  the 
Rejuilation. 

4.3 

Period covered and arrangements  for renewal or extension 

The proposed  Regulation has no fixed  duration. 

The  proposal  provides  that  while  Council  determines  the  categories  of  fees  levied  on 
applicants,  the  actual  level  of  fees  may  be  modified  by  means  of  a  Standing  Committee 
procedure as set out in Article 73 of Council  Regulation  (EEC) No 2309/93. 

Any  other  changes  to  the  Regulation  may  only  be  made  by  Council  after  consultation  oi' 
European  Parliament. 

Within  five  years  of  its  entry  into  force,  the  Commission  vvill  present  a  report  on  the 
implementation of the Regulation. 

5. 

CLASSIFICATION OF EXPENDITURE  OR REVENUE 

The contribution  from  the general budget of the European  Community  is classified as: 

-  Non-compulsory expenditure 
-  Differentiated  appropriations 

Revenue  from  fees  and  other  administrative  charges  levied  on  applicants  and  holders  ol 
Community marketing authorisations are ovvn resources for the EMEA budget. 

i* 

6. 

TYPE  OF EXPENDITURE  OR  REVENUE 

6.1 

Revenue of the  EMEA 

-  Partial contribution  to the revenue of the EMEA from  the Community budget 
- 

Income from  fees generate own respurces for the EMEA budget 

The proportion  of fees  in the total EMEA  budget  is expected  to rise to about  75 percent  by  the 
year  2000.  Taking  into  account  the  increase  in  activities  of  the  EMEA,  the  Community 
contribution  should stabilise, at about the  1997 level of ECU  14 million. 

6.2 

ExpendifureoftheEMEA 

- 

Staffcosts: 

Title I of the budget covers salary costs of EMEA personnel, together with costs of  interim 
and  other  external  support  staff.  Other  staff-related  expenditure  (social  welfare,  staff 
missions, annual medical costs, recruitment costs, etc.) is also made under this title. 

Building and equipment costs: 

Title  II  relates  to  expenditure  for  the  building  occupied  by  the  EMEA.  costs  associated 
with  the  rental  of  the  building,  equipment,  1T  networks  and  other  miscellaneous 
operational costs. The costs of external  studies are also met from  this title. 

-  Operational expenditure: 

Title  III of the budget  relates to the operational  expenditure  of the  EMEA. This  covers  in 
particular the costs  of meetings and  payments  made to Member State  national  competent 
authorities for the provision of rapporteur and inspection services. 

18 

FINANCIAL IMPACT 

7.1  Method of calculating the total cost of the action 

The'cost  of the action  is calculated  on  the  basis  of workload  projections  prepared  on  the  basis 
of  consultation  w.ith  appropriate  industry  representative  organisations  and  directly  vvith 
undertakings  in  the  sector.  The  budgetary  needs  are  therefore  established  in  line  with  the 
operational  resources  required  to meet this expected  workload  and the work programme  of the 
EMEA. 

EMEA  budgetary  perspectives  (ECU  millions) 

EMEA budgetary needs 

1998 

33.9 

1999 

44 

2000 

2001* 

2002* 

48 

52 

56 

Projected  fee revenue 

19.6 

29.6 

33.6 

37.6 

41.6 

Miscellaneous revenue 
(bank, interest etc) 
Shortfall  to be met by 
Community  contribution 

0.3 

14 

0.4 

14 

0.4 

14 

0.4 

14 

0.4 

14 

Article  71  of  Council  Regulation  (EEC)  No  2309/93  provides  that  the  Commission  will 
produce  a  report  for  the  year  2000  on  the  European  authorisation  system,  including  the 
operation  of the  EMEA. This  may  lead  to a  revision  of  the  scope  of the centralised  procedurc 
and activities of the EMEA. 

It is therefore  difficult  to provide a meaningful  forecast  of activities over the next 5 year  period 
beyond  the  year  2000.  On  the  basis  of  the  current  scope  of  the  activities  of  the  EMEA  the 
contribution  of the Community  is not likely to exceed  present levels. 

Projected  fee  revenue  is  calculated  on  the  basis  of  fee  levels  and  structure  prcsented  in  this 
proposal  using a modei based on the practical experience of the EMEA. 

Calculations  only  take  into  account  the  normal  activities  of  the  EMEA  within  the  European 
I'nion. The extension  of  EMEA  activities, e.g.  to countrics of the  European  Economic  Area  or 
the acccssion of new Member States, would require additional  resources. 

7.2 

Itemised brcakdown of cost 

At the request of the Commission,  a contribution  to the  preparation  of the new  Regulation  was 
made by the  EMEA which  looked  at the costs  of  Member  States and  EMEA Secretariat  in the 
operation  of  the  centralised  procedure.  The  report  surveyed  Member  State  competent 
authorities  on  the  actual  costs  associated  with  the  evaluation  of  medicinal  products  for  which 

These projections are made on the basis that EMEA scope of activities will not be changed 

they  had  acted  as  rapporteur  or  co-rapporteur,  or  for  which  their  inspection  departments  had 
provided services. The survey also looked at the costs of the EMEA  Secretariat. 

The report of the Board, included detailed  analysis  of: 

- 

- 
- 
- 
- 

actual  costs  of  rapporteur  and  co-rapporteurship  relating  to  the  centralised  evaluation  of 
individual  human and veterinary  medicines 
costs of inspections carried  out under the centralised  procedure 
costs for variations, post-marketing  surveillance, etc. 
estimated EMEA secretariat costs 
breakdown  of  the  expected  resource  contributions  from  the  Member  States  to  EMEA 
activities 

The  report  was  adopted  by  the  Management  Board  of  the  EMEA  on  5  February  1997  and 
transmitted  to the Commission. The  report,  after  deletion  of confidential  information,  vvas also 
circulated  to  appropriate  European  interested  parties  and  made  available  to  the  public 
(EMEA/MB/057/96.Public). 

The Management  Board made a number of findings,  including: 

- 

- 

- 

- 

fee  levels  provided  for  in  Council  Regulation  (EC) No  297/95  do not  cover  the  real  costs 
incurred  by either  the  national  competent  authorities  or  the  EMEA,  and  that  therefore  fee 
levels should be increased 

current  fee  structure  should  be  revised  to  introduce  an  annual  fee  for  the  funding  of  post-
authorisation  surveillance and maintenance  activities 

the  Board  also recommended  that  by the  year  2000 the  majority  of EMEA  revenue  should 
derive  from  fees,  with  perhaps  25  percent  of  revenue  continuing  to  come  from  the  EU 
budget 

the  analysis  of  actual  costs  incurred  by  national  competent  authorities  revealed  that  the 
average  cost  of  evaluation  for  a  medicinal  product  for  human  use  was  almost 
ECU  80  000  -  considerably  higher  than  the  ECU  35  000  to  50  000  currently  payablc  to 
rapporteurs or co-rapporteurs 

The Board also highlighted: 

- 

- 

that  costs  associated  with  evaluation-related  services  provided  by  the  EMEA  should  be 
recovered  from  fees  levied on applicants and Community marketing authorisation  holdcrs 

the  importance  of  compensation  paid  to  them  to  finance  their  involvement  in  EMEA 
activities 

7.3 

Provisional schedule of appropriations 

Not applicable, since this is a Community contribution  to the EMEA budget. 

2o 

7.4 

Community  contribution  under hcading  B5-3  12  0 "European Agency  for  the 
Evaluation  of  Medicinal  Products" 

Sincc  this  is  an  autonomous  body  endowed  with  legal  personality  and  possessing  its  own 
budgct,  the  contribution  from  the  Community  budgct  is  entered  under  Hcading  B5-312.  The 
amount  of  this contribution  is cstimated  on  the  basis of the costs  referred  to abovc  and  expected 
fee  revenue. 

The  proposcd  new  level  and  structurc  of  fees  aims  at  allowing  the  EMEA,  in  the  long-tcrm,  to 
derivc  75  pcrcent  of  its  rcvcnues  from  fees,  with  the  Community  contribution  falling  to  about 
25  pcrcent  of total  budgct. 

Although  represcnting  a  gradually  smaller  proporlion  of  total  EMEA  revenue,  there  is  a 
continuing  need  for  a  Community  contribution  to  cover  the  necessary  public  health  and 
interest  of  specific  companics  Cc.g. 
supervisory 
pharmacovigilancc,  technical  harmonisation,  ctc). 

funclions  not  carried  out 

the 

in 

Diiiing  the  initial  trausition  period,  Ihe  Coinniunily  contrihution  represcnted  a  suhstanti.il 
proporlion  of  Ihe total  EMEA  budgct. 

Ihe  projecled  EMEA  budgctary  perspectivcs  show  a  clear  trend  to  a  reduction  oi'  the 
proporlion  from  ovcr  one  half  to  one  quartcr  of  the  total  budgct.  The  proposcd  Regulation 
provides  for  a  level  and  structurc  of  fees  which  should  permit  this  trend  for  the  Comniunity 
contribution  to the currcnt  activilies of the  EMEA  to be eonlinued  in the  fuliire. 

8. 

FRAUI)  PREVENTION  MEASURES 

Council  Regulation  (EEC)  No  2309/93  provides  for  specific  adoption  and  budgctary  control 
proccdurcs.  Each  ycar  the  Management  Board,  composed  of  rcprcsentativcs  of  the  Membcr 
States, Commission  and  Parliamcnl,  arc  responsible  for adopling  the draft  budgct  (Articlc  55). 

Currcnt  budgctary  control  mcchanisms  arc  deseribed  in  Articlc  57,  iucluding  the  appointmcut 
of  a  financial  controllcr  by  the  Management  Board  and  review  o\'  EMEA  revenue  and 
cxpcnditurc accounls by  Ihe Court  of  Auditors. 

It  should  be  notcd  that  a draft  Regulation  is under  preparation  by  the  Commission  which  would 
transfer  the  financial  control  function  for  the  EMEA  to  the  Financial  Controllcr  oi'  the 
Commission. 

21 

ELEMENTS OF COST-EFFECTIVENESS ANALYSIS 

9.1 

Spccific  and quantifiable  objectives 

The  provisions  of  Council  Regulation  (EEC)  No  2309/93  setting  up  the  new  European 
registration  system  seek  to  promote  the  free  movement  of  medicinal  products  in  the 
Community,  while at the  same  time  providing  better  public  health  protection.  In  particular,  it 
has  been  shown  since the  centralised  procedure  entered  into force  that the  Regulation  permits 
rapid  access  for  new  medicinal  products  to  the  single  market  and  has  ensured  greater 
harmonisation  of the conditions governing the placing on the market of medicinal products. 

A  single  evaluation,  meeting  the  highest  possible  scientific  standards,  is  carried  out  by  the 
EMEA, working in partnership with the Member States. The EMEA opinion  forms the basis for 
the  Commission  decision-taking  procedure  for  the  granting  of  Community  marketing 
authorisatipns. 

Consequently, thesc provisions come under three niajor Comnumity strategies: 

- 
- 

- 

completion of the internal  market  in the pharmaceuticals sector 
industria! policy  to  promote  the  competitiveness  of  European  research  and  development-
based companies 
creation  of  a  trans-European  communications  and  early  warning  network  linking  the 
competent authorities, the EMEA and the Commission 

9.2 

Grounds for operation 

The justifications  made for  Council  Regulation  (EC) No 297/95 continue to apply, namely that 
the new European authorisation  system: 

- 

- 
- 

- 

prevents  unnecessary  duplication  of  scientific  evaluation  for  products  authorised  through 
the centralised  procedure by reducing the number of evaluations from  15 to l 
reduces scope for conflicts  between competent authorities through technical  harmonisation 
accelerated  evaluation  permits  pharmaceutical  companies  to make their  products  availablc 
more quickly, giving patients faster access to innovative medicines 
promotes the single  market  and  free  circulation  of  pharmaceuticals  through  the  placing on 
the market of medicinal  products under the same conditions throughout the EU 

E\en  taking  into  account  recent  increases  in  the  fees  of  Member  State  competent  authorities, 
the  level  o\"  fees  payable  to  the  EMEA  for  a Community  marketing  authorisation  amount  to 
about  half  thc  total  corresponding  fees  payable  to  each  of  the  fifteen  national  competent 
authorities. 

The  level  of  fees  proposed  do  not  place  an  excessive  burden  on  the  economic  resources  of 
undertakings  in  the  sector.  Research  and  development  costs  for  a new molecule are  generally 
estimated at ECU 200 million. The fees payable to the EMEA represent a very small  proportion 
of this total. 

Experience  over  the first  two years  show  that  in return  for  fees  paid to the  EMEA,  applicants 
receive a service which  is both  rapid and effective.  Thus allowing  innovative nevv medicines  to 

22-

be  placed  on the market more quickly  than  before  - benefiting  both  patients and the  European 
research  and  development-based  industry.  This  also  permits  authorisation  holders  to  begin  to 
recover their costs earlier. 

The  amount  of fees  payable  by applicants  therefore  appears  modest  and  reasonable  compared 
to  fees  payable  at national  level. It also  represents  an efficient  means of financing the vvork of 
the EMEA, reducing the burden on the general budget of the Community. 

9.3  Monitoring and evaluation of the operation 

The principal performance  indicators will continue to be: 

- 

- 

- 

actual  number  of  applications  submitted  by  companies  under  the  centralised  procedure, 
taking into account the choice left open to undertakings 
level  of  post-marketing  surveillance  activity  for  centrally-authorised  medicinal  products 
and other Community referral  procedures for nationally authorised  products 
compliance  with  300-day  evaluation  and  decision-taking  deadline  by  the  EMEA  and  the 
Commission; the speed of the nevv system  is a crucial  factor  for the European research  aiul 
devclopment based  industry 

Givcn  the systematic  use of the  mutual  recognition  procedure  for the majority  of conventional 
medicines  from  the  beginning  of  1998,  it  is  expected  that  there  will  be  an  increasc  in  the 
number  of  arbitrations  referred  to  the  EMEA.  This  vvill  also  be  an  important  performance 
indicator for the European authorisation  system. 

Evaluation: 

- 

- 

- 

the  EMEA  Management  Board  adopts  an  annual  report  on  the  activities  of  the  Agency 
vvhich is forwarded  to the Member States, Commission, Council and  Parliament (Article 56 
of Council Regulation (EEC)No  2309/93) 
the Executive  Director  of the EMEA  is responsible  for ensuring that time limits laid  down 
for the adoption of opinions are respected (Article 55) 
at  the  initiative  of  the  Executive  Director,  the  Management  Board  has put  in place  a joint 
industry-regulators  panel to review performance  of the EMEA 

An  evaluation  of  the  implementation  of  the  proposed  Regulation  will  be  presented  by  the 
Commission  within five years of its entry  into force. 

The  Commission  is  also  required  to  present  a  report  on  the  overall  implementation  of  the 
centralised  and  deccntralised  European  registration  systems within  six  years  of  the  entry  into 
force of Council Regulation (EEC) No 2309/93 (Article 71). 

23 

ISSN 0254-1475 

COM(98) 21  final 

DOCUMENTS 

EN 

01  15 

Catalogue  number  :  CB-CO-98-016-HN-C 

1SBN  92-78-30158-2 

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