Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
Date: 2013-06-26
Institutions: European Commission
Subjects: European Medicines Agency, drug surveillance, market approval, medicinal product, quasi-fiscal charge

EUROPEAN 
COMMISSION 

Brussels, 26.6.2013  
COM(2013) 472 final 

2013/0222 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on fees payable to the European Medicines Agency for the conduct of 
pharmacovigilance activities in respect of medicinal products for human use 

(Text with EEA relevance) 

{SWD(2013) 234 final} 
{SWD(2013) 235 final} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

The  legal  framework  of  pharmacovigilance  for  medicinal  products  for  human  use  marketed 
within  the  EU  is  provided  for  in  Regulation  (EC)  No  726/20041  ('the  Regulation')  and  in 
Directive 2001/83/EC2 ('the Directive'). The EU pharmacovigilance legislation for medicinal 
products for human use has been subject to a major review and an impact assessment that led 
to the adoption of a revised legislation3 in 2010, which strengthens and rationalises the system 
for safety monitoring of medicines on the European market. This legislation is applicable as 
of  July  2012.  It  provides  for  a  number  of  EU-wide  procedures  to  assess  pharmacovigilance 
data  which  may 
the 
pharmacovigilance legislation were introduced in 2012 following the 'Mediator' case4.  

to  regulatory  action.  Some  additional  amendments 

lead 

to 

Whilst  streamlining  the  EU-wide  post-authorisation  safety  assessment  and  monitoring  of 
medicines,  the  revised  pharmacovigilance  legislation  significantly  widened  the  tasks  of  the 
European Medicines Agency ('the Agency') with regard to pharmacovigilance, irrespective of 
whether  the  medicinal  products  have  been  authorised  via  the  'centralised  procedure'  (in 
accordance with the Regulation) or via national procedures (in accordance with the Directive). 
The  Agency  has  therefore  acquired  pharmacovigilance  competences  also  for  nationally 
authorised  medicines,  in  addition  to  reinforced  competences  for  centrally  authorised 
medicines.  

to  marketing  authorisation  holders.  These 

To finance these activities, the revised pharmacovigilance legislation provides for fees to be 
to 
charged 
pharmacovigilance  activities  performed at the level of the EU, notably in the context of the 
EU-wide  assessment  procedures.  These  procedures  include  scientific  assessment  carried  out 
by rapporteurs from the national competent authorities of the Member States. These fees are 
therefore  not  intended  to  cover  the  pharmacovigilance  activities  of  the  national  competent 
authorities  performed  at  national  level.  Member  States  may  accordingly  continue  to  charge 
fees for the activities performed at national level which should, however, not overlap with the 
fees laid down in this legal proposal. 

should  be 

related 

fees 

Since the revised pharmacovigilance legislation only concerns medicinal products for human 
use, this proposal on fees for pharmacovigilance only covers these medicinal products. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

Public Consultation 

As part of the preparation of this legal proposal on fees for pharmacovigilance, DG SANCO, 
in close collaboration with the Agency, drafted a concept paper for public consultation. Given 
that the Union-wide pharmacovigilance procedures foreseen in the revised pharmacovigilance 
legislation  are  new  procedures,  the  concept  paper  used  existing  procedures  that  were 
considered  sufficiently  similar  as  benchmarks  for  the  new  procedures.  In  addition,  a 

1 
2 
3 

4 

OJ L 136, 30.4.2004. 
OJ L 311, 28.11.2001. 
Regulation  (EU)  No  1235/2010  of  the  European  Parliament  and  of  the  Council  amending,  as  regards 
pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 and Directive 
2010/84/EU of the European Parliament and of the Council amending, as regards pharmacovigilance, 
Directive 2001/83/EC, OJ L 348 of 31.12.2010. 
Directive  2012/26/EU,  OJ  L  299  of  27.10.2012,  and  Regulation  (EU)  No  1027/2012,  OJ  L  316  of 
14.11.2012. 

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pharmacovigilance service fee to be charged on an annual basis was considered in the paper, 
in order to cover those activities of the Agency that benefit industry in general, but for which 
it is virtually impossible to identify the individual addressee(s). 

The Commission launched the public consultation on 18 June 2012 with a deadline for replies 
on 15 September 2012. In total, 85 replies were received (mainly from industry, but also from 
the  Member  States  and  other  stakeholders).  The  summary  of  the  replies  to  the  public 
consultation was published on the website of DG SANCO on 29 November 2012. In general, 
the  comments  were  rather  negative,  notably  as  regards  the  amounts  proposed  for  the  fees. 
They  were  considered  to  be  too  high  and  without  sufficient  justification  as  regards  the 
workload and costs. Grouping of marketing authorisation holders, especially for submitting a 
single Periodic Safety Update Report, was considered by many as not applicable in practice. 
Many  respondents  questioned  the  benchmarks  that  were  used  and  considered  that 
pharmacovigilance  fees  should  be  rather  based  on  estimations  of  the  time  spent  and  the 
associated  cost  of  the  assessment  work.  Several  industry  respondents  flagged  the  risk  of 
possible  double  charging  of  the  Agency  and  the  Member  States,  given  that  many  of  the 
competent  authorities  in  the  Member  States  currently  charge  fees  for  pharmacovigilance. 
Particular  concerns  were  expressed  by  small  and  medium-sized  enterprises,  stating  that 
despite the proposed fee reductions in the concept paper, the amounts were still too high. Also 
many responses from industry associations, representing products such as generic medicinal 
products,  considered  that  the  proposed  fee  levels  would  unfairly  affect  marketing 
authorisation holders with a large portfolio of products with well-established safety profiles.  

Impact assessment 

In line with the above-mentioned comments, the Impact Assessment report that accompanies 
this proposal considered several options, based on estimation of cost. This new approach is in 
line  with  the  recommendations  of  the  European  Court  of  Auditors5  and  the  European 
Parliament6 to base the payment system for services provided by Member States' authorities 
on costs.  

Consistent with the legal proposal on pharmacovigilance of 2008 and with the EU legislation 
on pharmacovigilance, all options of legislative action were based on the assumption that the 
total cost related to pharmacovigilance would be covered through fees. Regulation (EU) No 
1235/2010  provides  notably  for  a  new  wording  of  article  67(3)  of  Regulation  (EC)  No 
726/2004: 'The Agency’s revenue shall consist of a contribution from the Union and fees paid 
by undertakings for obtaining and maintaining Union marketing authorisations and for other 
services provided by the Agency, or by the coordination group as regards the fulfilment of its 
tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC.’ 
Recital  13  notably  states  that  'It  should  be  ensured  that  adequate  funding  is  possible  for 
pharmacovigilance  activities  by  empowering  the  Agency  to  charge  fees  to  marketing 
authorisation holders. ' and Recital 24 explains that the new legal provisions 'widen the tasks 
of the Agency with regard to pharmacovigilance, including the monitoring of literature cases, 
the improved use of information technology tools and the provision of more information to the 
general  public.  The  Agency  should  be  enabled  to  fund  these  activities  from  fees  charged  to 
marketing authorisation holders.' 

The selected option foresees two separate types of fees: 

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6 

Report on the annual accounts of the European Medicines Agency for the financial year 2011, together 
with the Agency’s replies (2012/C 388/20), OJ C 388/116, 15.12.2012 
Resolution of the European Parliament of 23 October 2012 with observations forming an integral part 
of its Decision on discharge in respect of the implementation of the budget of the European Medicines 
Agency for the financial year 2010, OJ L 350, 20/12/2012 p. 0082 - 0087 

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(1) 

(2) 

Fees  for  procedures  for  the  assessment  of  periodic  safety  update  reports,  post-
authorisation safety studies and pharmacovigilance referrals.  

An  annual  flat  fee  to  be  charged  to  marketing  authorisation  holders  having  at  least 
one  medicinal  product  that  is  authorised  in  the  EU  and  registered  in  the  database 
provided for in Article 57(1)(l) of the Regulation. This annual flat fee would cover 
only  the  costs  of  the  pharmacovigilance  activities  of  the  Agency  other  than  those 
related  to  the  above-mentioned  procedures.  Therefore,  it  is  foreseen  that  the  fee 
revenue from the annual flat fee be retained by the Agency.  

Some fee reductions and fee waivers are foreseen in respect of the proposed fees:  

•  In line with the general EU policy to support small and medium-sized enterprises, 
reductions for medicinal products for which the marketing authorisation holder is 
a small or medium-sized enterprise would be granted for all types of fees. Micro 
enterprises  would  be  exempted  from  all  fees.  The  reduction  rates  for  small  and 
medium-sized  enterprises  are  based  on  the  comparisons  of  data  of  added  values 
per  employee  in  the  sector,  as  a  possible  measure  of  profitability  of  companies. 
The  proposed  contribution  of  small  and  medium  enterprises  to  the  financing  of 
pharmacovigilance was reduced accordingly, whereas micro-enterprises should be 
entirely exempt from the obligation to pay pharmacovigilance fees.  

•  Moreover,  certain  fee  reductions  reflect  the  risk-based  approach  of  the 
pharmacovigilance legislation acknowledging the differences in the safety profile 
of  new  and  more  established  medicinal  products  for  which  time  has  allowed  to 
collect data. A reduction of the annual flat fee is therefore proposed for authorised 
generic,  homeopathic  and  herbal  medicinal  products  and  for  medicinal  products 
authorised  on  grounds  of  well-established  medical  use.  However,  where  these 
medicinal products are included in the Union-wide pharmacovigilance procedures, 
the  full  fees  for  procedures  would  apply.  Registered  homeopathic  and  herbal 
medicinal products would be exempted from all fees.  

•  Finally,  as  marketing  authorisation  holders  for  medicinal  products  authorised 
under the Regulation currently pay an annual fee to the Agency for maintenance 
of  the  authorisation  including  pharmacovigilance  activities  covered  by  the 
proposed fee, these marketing authorisations would be exempted from the annual 
flat fee in order to avoid double charging. 

Marketing authorisation holders would be charged as follows:  

•  Marketing authorisation holders having at least one product involved in a Union-

wide pharmacovigilance procedure would be charged a fee for procedures, 

•  Marketing authorisation holders in the EU7, with the exceptions explained above, 

would be charged the annual flat fee. 

Therefore, marketing authorisation holders that are not involved in any EU procedure would 
only pay the annual flat fee component, with the above-mentioned exceptions. 

The criteria that were identified as the most decisive in analysing the impact of options were 
fairness,  proportionality  and  transparency  of  the  overall  pharmacovigilance  fee  system, 
including the adequacy of the relation between the work carried out and the type and level of 
fee.  Other  important  criteria  considered  within  the  analysis  were  the  stability  and  the 
simplicity of the Agency pharmacovigilance fee-system.  

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Registered in the database provided for in Article 57(1)(l) of the Regulation. 

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Under the selected option, fees are proportionate to the workload and the costs, but cannot be 
entirely  predictable  by  the  inherent  nature  of  the  pharmacovigilance  activities.  In  order  to 
avoid  extreme  cases  and  to  allow  for  a  readable,  applicable  and  usable  legislative  text,  it  is 
proposed  that  procedure-based  fees  generate  an  average  fee  revenue  that  is  based  on  the 
average estimated cost of each procedure. 

transparency.  With 

A combination of procedure-based fees and an annual flat fee has been considered to be the 
most transparent, cost-based, activity-based and proportionate way of setting the new fees, in 
order to cover the cost under the new pharmacovigilance legislation. This analysis was carried 
out in the light of a strong preference expressed by stakeholders for a policy approach based 
on  fairness  and 
the  products  being  part  of  a 
pharmacovigilance  procedure  at  EU  level  will  contribute  to  the  financing  of  the  cost  of  the 
procedure.  This  is  also  in  line  with  the  risk-based  approach  of  the  pharmacovigilance 
legislation. At the same time, the cost of general pharmacovigilance activities of the Agency, 
and only that part of its total pharmacovigilance cost, would be recouped through the annual 
flat  fee  charged  to  marketing  authorisation  holders  who  benefit  overall  from  the  EU 
pharmacovigilance  system.  These  activities  of  the  Agency  relate  notably  to  the  information 
technology systems, safety data management and literature monitoring. 

this  approach, 

In order to have a fair system, it was considered necessary to identify a single, chargeable unit 
as  there  are  different  ways  in  the  EU  of  assigning  authorisation  numbers  to  and  counting 
medicinal  products.  To  facilitate  adverse  reaction  reporting  and  signal  detection,  it  is 
necessary to describe medicinal products with maximum precision in order to take account of 
differences  in  strength,  pharmaceutical  forms,  routes  of  administration  etc.  Therefore,  the 
Agency has set up the structure of the database described in Article 57(2) of the Regulation to 
neutralise these differences by means of individual entries. These entries have been chosen as 
a chargeable unit. 

Remuneration of Member States authorities acting as rapporteurs 

In line with the above-mentioned recommendations of the European Court of Auditors and the 
European Parliament, it is proposed that rapporteurs from the national competent authorities 
of the Member States be remunerated according to a fixed scale based on estimations of cost. 
The  amount  of  remuneration  is  based  on  the  average  procedure  costs  as  estimated  for  each 
type of procedure. Where fee reductions apply, the remuneration of the Member States will be 
adjusted accordingly, including reductions for small and medium-sized enterprises which are 
in line with the policy of the Union to support small and medium-sized enterprises. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

Subsidiarity principle 

The Agency is a European decentralised Agency established under the Regulation and hence 
the  decision  on  its  funding  and  charging  of  fees  is  to  be  taken  at  the  EU  level.  The  new 
pharmacovigilance  legislation  provides  a  legal  base  for  the  Agency  to  charge  fees  for 
pharmacovigilance.  Hence,  only  the  Union  can  act  to  enable  the  Agency  to  charge  fees  for 
pharmacovigilance. 

Only pharmacovigilance activities that are performed at EU level and involving the Agency 
are  covered  by  this  proposal.  As  regards  pharmacovigilance  activities  remaining  at  national 
level, the EU is not competent and Member States may still continue charging national fees 
accordingly. 

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Proportionality principle 

The proposal does not go beyond what is necessary to achieve the general objective pursued, 
i.e.  to  introduce  fees  in  order  to  allow  the  proper  implementation  of  the  pharmacovigilance 
legislation that is applicable since July 2012. 

Legal basis 

The proposed Regulation is, like the EU pharmacovigilance legislation based on a dual legal 
basis: Article 114 and Article 168(4)(c) TFEU. The proposed Regulation is based on Article 
114  TFEU  as  differences  between  national  legislative,  regulatory  and  administrative 
provisions on medicinal products tend to hinder intra-Union trade and therefore directly affect 
the operation of the internal market. This Regulation ensures the availability of the necessary 
financial resources to apply the stream-lined Union procedures for the assessment of serious 
safety  issues  for  nationally  authorised  products,  which  have  been  introduced  amongst  other 
things to prevent or eliminate obstacles that could result from parallel procedures at national 
level. Thereby this Regulation contributes to the well-functioning of the internal market and 
the common post-marketing surveillance of medicinal products. 

In  addition,  the  proposed  Regulation  is  based  on  Article  168(4)(c)  TFEU  as  it  aims  at 
supporting  the  goal  of  setting  high  standards  of  quality  and  safety  of  medicinal  products. 
According to Articles 168(4) and 4(2)(k) TFEU this Union competence is – like Article 114 
TFEU  -  a  shared  competence  which  is  exercised  with  the  adoption  of  the  proposed 
Regulation. 

The  proposed  Regulation  aims  at  setting  high  standards  of  quality  and  safety  for  medicinal 
products  as  it  ensures  the  availability  of  sufficient  financial  resources  to  perform  the 
pharmacovigilance  activities  that  are  necessary  to  guarantee  that  high  standards  are 
maintained once the product is authorised. 

Article 168(4)(c) TFEU cannot serve as sole legal basis, but needs to be complemented with 
the  legal  basis  of  Article  114  TFEU  as  it,  as  set  out  above,  pursues  equally  as  object  the 
establishment  and  functioning  of  the  internal  market,  and  the  setting  of  high  standards  of 
quality and safety for medicinal products. 

Choice of the legal instrument 

Since the Treaty on the Functioning of the European Union became applicable, all legislative 
procedures  are  normally  based  on  the  previous  'co-decision  procedure'  involving  both  the 
Council and the European Parliament. Therefore, for legal certainty, it is proposed to create 
for  pharmacovigilance  fees  a  new  Regulation  of  the  Council  and  the  European  Parliament, 
which will be subject to the ordinary legislative procedure (Article 294 of the TFEU).  

The adoption of a proposal for a Regulation on pharmacovigilance fees is aimed at allowing 
the Agency to have adequate funding in order to properly implement the already applicable 
pharmacovigilance legislation.  
The existing Council Regulation (EC) No 297/958 of 10 February 1995 on fees payable to the 
Agency  would  continue  to  apply,  whereas  the  proposed  Regulation  would  apply  to 
pharmacovigilance  fees  for  activities  laid  down  in  the  applicable  pharmacovigilance 
legislation. The two legal instruments would be complementary. 

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OJ L 35, 15.2.1995, p. 1. 

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4. 

BUDGETARY IMPLICATION  

the 

legal  proposal  on  pharmacovigilance  of  2008  and  with 

the 
Consistent  with 
Pharmacovigilance  legislation  adopted  in  2010,  according  to  which  the  Agency  should  be 
enabled  to  fund  pharmacovigilance  activities  from  fees  charged  to  marketing  authorisation 
holders  (see  section  on  Impact  Assessment),  all  options  of  legislative  action,  including  the 
option which underpins this proposal, were based on the assumption that the costs related to 
pharmacovigilance would be covered through fees.  

Therefore,  no  impact  on  the  EU  general  budget  is  foreseen  in  the  accompanying  financial 
statement of this proposal. 

5. 

OPTIONAL ELEMENTS  

European Economic Area 

The proposed act is of relevance to the EEA.

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2013/0222 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on fees payable to the European Medicines Agency for the conduct of 
pharmacovigilance activities in respect of medicinal products for human use 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 and Article 168(4)(c) thereof 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 
Having regard to the opinion of the European Economic and Social Committee9,  
Having regard to the opinion of the Committee of the Regions10,  

Acting in accordance with the ordinary legislative procedure, 

Whereas:  

(1) 

(2) 

The revenues of the European Medicines Agency (hereinafter ‘the Agency’) consist of 
a  contribution  from  the  Union  and  fees  paid  by  undertakings  for  obtaining  and 
maintaining  Union  marketing  authorisations  and  for  other  services  referred  to  in 
Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the 
Council of 31 March 2004 laying down Community procedures for the authorisation 
and supervision of medicinal products for human and veterinary use and establishing a 
European Medicines Agency11. 

The provisions on pharmacovigilance relating to medicinal products of human use laid 
down  in  Regulation  (EC)  No  726/2004  and  Directive  2001/83/EC  of  the  European 
Parliament and of the Council of 6 November 2001 on the Community code relating to 
medicinal  products  for  human  use12  were  amended  by  Directive  2010/84/EU  of  the 
European  Parliament and of the Council of 15 December 2010 amending, as regards 
pharmacovigilance,  Directive  2001/83/EC  on  the  Community  code  relating  to 
medicinal products for human use13, Regulation (EU) No 1235/2010 of the European 
Parliament  and  of  the  Council  of  15 December  2010  amending,  as  regards 
pharmacovigilance  of  medicinal  products  for  human  use,  Regulation  (EC) 
No 726/2004 
the  authorisation  and 
supervision  of  medicinal  products  for  human  and  veterinary  use  and  establishing  a 
European  Medicines  Agency,  and  Regulation  (EC)  No 1394/2007  on  advanced 

laying  down  Community  procedures  for 

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13 

OJ C , , p. . 
OJ C , , p. . 
OJ L 136, 30.4.2004, p. 1. 
OJ L 311, 28.11.2001, p. 67. 
OJ L 348, 31.12.2010, p.74. 

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therapy  medicinal  products14,  Directive  2012/26/EU  of  the  European  Parliament  and 
of  the  Council  of  25 October  2012  amending  Directive  2001/83/EC  as  regards 
pharmacovigilance15 and Regulation (EU) No 1027/2012 of the European Parliament 
and  of  the  Council  of  25 October  2012  amending  Regulation  (EC)  No 726/2004  as 
regards  pharmacovigilance16.  Those  amendments  only  cover  medicinal  products  for 
human  use.  Those  amendments  provide  for  new  pharmacovigilance  tasks  for  the 
Agency  including  Union-wide  pharmacovigilance  procedures,  the  monitoring  of 
literature cases, the improved information technology tools and the provision of more 
information  to  the  general  public.  Furthermore,  the  pharmacovigilance  legislation 
stipulates that the Agency should be enabled to fund those activities from fees charged 
to marketing authorisation holders. New categories of fees should therefore be created 
to cover the new and specific tasks of the Agency. 

In order to enable the Agency to charge fees for those new pharmacovigilance tasks, a 
Regulation  should  be  adopted.  The  fees  provided  for  in  this  Regulation  should  be 
applicable  without  prejudice  to  the  fees  laid  down  in  Council  Regulation  (EC)  No 
297/95 of 10 February 1995 on fees payable to the Agency 17as that Regulation covers 
fees  for  activities  of  the  Agency  in  respect  of  medicinal  products  authorised  under 
Regulation (EC) No 726/2004. 

This Regulation should be based on the double legal basis of Article 114 and Article 
168(4)(c) of the Treaty on the Functioning of the European Union (TFEU). It aims at 
financing pharmacovigilance activities that contribute to achieving an internal market 
as  regards  medicinal  products  for  human  use,  taking  as  a  base  a  high  level  of 
protection  of  health.  At  the  same  time,  the  Regulation  provides  financial  resources 
supporting the activities to address common safety concerns in order to maintain high 
standards  of  quality,  safety  and  efficacy  of  medicinal  products  for  human  use.  Both 
objectives are being pursued simultaneously and are inseparably linked, so that one is 
not secondary to another. 

The structure and amounts of the fees for pharmacovigilance collected by the Agency 
as well as the rules for payment should be established. The structure of the fees should 
be  as  simple  as  possible  to  apply  in  order  to  minimise  the  related  administrative 
burden. 

In line with the Joint Statement of the European Parliament, the Council of the EU and 
the European Commission of 19 July 2012 on the Common Approach on decentralised 
agencies,  for  bodies  for  which  the  revenue  is  constituted  by  fees  and  charges  in 
addition  to  the  Union  contribution,  fees  should  be  set  at  a  level  such  as  to  avoid  a 
deficit  or  a  significant  accumulation  of  surplus  and  be  revised  when  this  is  not  the 
case. Therefore, the fees set out in this Regulation should be based on an evaluation of 
the Agency’s estimations and forecasts as regards its workload and related costs and 
on  the  basis  of  an  evaluation  of  the  costs  of  the  work  carried  out  by  the  competent 
authorities  of  the  Member  States  acting  as  rapporteurs  in  accordance  with  Articles 
61(6),  62(1)  of  Regulation  (EC)  No  726/2004  and  Articles  107e  107q  and  107j  of 
Directive 2001/83/EC. 

(3) 

(4) 

(5) 

(6) 

(7) 

Fees referred to in this Regulation should be transparent, fair and proportionate to the 
work carried out. 

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17 

OJ L 348, 31.12.2010, p.1. 
OJ L 299, 27.10.2012, p.1. 
OJ L 316, 14.11.2012, p.38. 
OJ L 35, 15.2.1995, p. 1. 

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(8) 

This  Regulation  should  only  refer  to  fees  which  are  to  be  levied  by  the  Agency, 
whereas the competence to decide on possible fees levied by the competent authorities 
of the Member States should remain with the Member States. Marketing authorisation 
holders should not be charged twice for the same pharmacovigilance activity. Member 
States  should  therefore  not  levy  fees  for  the  activities  which  are  covered  by  this 
Regulation. 

(9) 

For reasons of predictability and clarity, the amounts of the fees should be established 
in euro. 

(10)  Two  different  types  of  fees  should  be  levied  under  this  Regulation  in  order  to  take 
account of the diversity of tasks of the Agency and of the rapporteurs. Firstly, fees for 
the  pharmacovigilance  procedures  carried  out  at  Union  level  should  be  charged  to 
those  marketing  authorisation  holders  whose  medicinal  products  are  part  of  the 
procedure. Those procedures relate to the assessment of periodic safety update reports, 
assessment  of  post-authorisation  safety  studies  and  assessments  in  the  context  of 
referrals  initiated  as  a  result  of  pharmacovigilance  data.  Secondly,  an  annual  flat  fee 
should  be  charged  for  other  pharmacovigilance  activities  carried  out  by  the  Agency 
that  benefit  marketing  authorisation  holders  overall.  Those  activities  relate  to 
information technology, notably maintenance of the 'Eudravigilance' database referred 
to in Article 24 of Regulation (EC) No 726/2004, signal detection and monitoring of 
selected medical literature.  

(11)  Marketing  authorisation  holders  for  medicinal  products  authorised  under  Regulation 
(EC)  No  726/2004  already  pay  an  annual  fee  to  the  Agency  for  the  maintenance  of 
their  authorisations,  which  includes  pharmacovigilance  activities  that  are  covered  by 
the annual flat fee established by this Regulation. In order to avoid double charging for 
those  pharmacovigilance  activities  of  the  Agency,  the  annual  flat  fee  established  by 
this  Regulation  should  not  be  charged  for  marketing  authorisations  granted  under 
Regulation (EC) No 726/2004. 

(12)  The work carried out at Union level in respect of the assessment of non-interventional 
post-authorisation  safety  studies  imposed  by  an  authority  and  of  which  the  protocol 
has  been  endorsed  by  the  Pharmacovigilance  Risk  Assessment  Committee,  involves 
the supervision of these studies, starting from the assessment of the draft protocol, and 
is not limited to the assessment of the final study reports. Therefore, the fee levied for 
this procedure in respect of studies that have been finalised should cover all the work 
relating  to  the  study.  In  order  to  avoid  double  charging,  marketing  authorisation 
holders  who  are  charged  the  fee  for  the  assessment  of  non-interventional  post-
authorisation  safety  studies  imposed  by  an  authority,  should  be  exempted  from  any 
other fee charged by a competent authority for the submission of those studies. 

(13)  Rapporteurs  rely  for  their  assessment  on  the  scientific  evaluation  and  resources  of 
national marketing authorisation bodies, whilst it is the responsibility of the Agency to 
coordinate the existing scientific resources put at its disposal by the Member States. In 
view of that and to ensure adequate resources for the scientific assessments relating to 
the  Union-wide  pharmacovigilance  procedures,  the  Agency  should  remunerate  the 
scientific  assessment  services  provided  by  the  rapporteurs  appointed  by  Member 
States as members of the Pharmacovigilance Risk Assessment Committee referred to 
in  Article  56(1)(aa)  of  Regulation  (EC)  No  726/2004  or,  where  relevant,  by 
rapporteurs  in  the  coordination  group  referred  to  in  Article  27  of  Directive 
2001/83/EC. The level of remuneration for the work carried out by those rapporteurs 
should be based on average estimations of the workload involved and should be taken 

EN 

10 

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into  account  in  setting  the  level  of  the  fees  for  Union-wide  pharmacovigilance 
procedures.  

(14)  Fees should be levied on a fair basis on all marketing authorisation holders. Therefore, 
a  single  chargeable  unit  should  be  established  irrespective  of  the  procedure  under 
which  the  medicinal  product  has  been  authorised,  either  under  Regulation  (EC) 
No 726/2004  or  under  Directive  2001/83/EC  and  the  way  in  which  authorisation 
numbers are assigned by the Member States. The individual entries corresponding to 
authorisations  in  the  database  referred  to  in  Article  57(1)(l)  of  Regulation  (EC)  No 
726/2004 based on information from the list of all medicinal products for human use 
authorised in the Union referred to in Article 57(2) thereof meet this objective. 

(15) 

In  line  with  the  policy  of  the  Union  to  support  small  and  medium-sized  enterprises, 
reduced fees should apply to small and medium-sized enterprises within the meaning 
of  Commission  Recommendation  2003/361/EC  of  6  May  2003  concerning  the 
definition of micro, small and medium-sized enterprises18. Consistent with this policy, 
micro  enterprises  within  the  meaning  of  that  Recommendation  should  be  exempted 
from all fees under this Regulation.  

(16)  Generic  medicinal  products,  medicinal  products  authorised  under  the  provisions 
relating to well-established medicinal use, authorised homeopathic medicinal products 
and authorised herbal medicinal products should be subject to a reduced annual flat fee 
as those products generally have a well-established safety profile. However, in cases 
where these products are part of any of the Union-wide pharmacovigilance procedures, 
the  full  fee  should  be  charged  in  view  of  the  work  involved.  As  the  legislation  on 
pharmacovigilance  encourages  the  conduct  of  joint  post  authorisation  safety  studies, 
marketing authorisation holders should share the applicable fee in case a joint study is 
submitted. 

(17)  Homeopathic and herbal medicinal products registered in accordance with Article 14 
and Article 16a of Directive 2001/83/EC should be excluded from this Regulation as 
the  pharmacovigilance  activities  for  these  products  are  carried  out  by  the  Member 
States. 

(18) 

In order to avoid disproportionate administrative workload for the Agency, reductions 
and  exemptions  provided  for  in  this  Regulation  should  apply  on  the  basis  of  a 
declaration  of  the  marketing  authorisation  holder  that  claims  to  be  entitled  to  the 
reduction or the exemption. The submission of incorrect information should therefore 
be discouraged through an increase of the applicable amount of the fee. 

(19)  For  reasons  of  consistency,  deadlines  for  the  payment  of  fees  levied  under  this 
Regulation should be established taking due account of the deadlines of the procedures 
relating  to  pharmacovigilance  provided  for  in  Regulation  (EC)  No  726/2004  and 
Directive 2001/83/EC.  

(20)  Fees  provided  for  under  this  Regulation  should  be  adapted  when  appropriate  to  take 
account  of  inflation  and,  for  that  purpose,  the  European  Index  of  Consumer  Prices 
published by Eurostat pursuant to Council Regulation (EC) No 2494/95 of 23 October 
1995 concerning harmonised indices of consumer prices19 should be used. 

(21) 

In order to allow for a sustainable operation of the pharmacovigilance activities of the 
Agency and an appropriate balance between the fee revenue and the underlying costs, 

18 
19 

OJ L 124, 20.5.2003, p.36. 
OJ L 257, 27.10.1995, p.1.  

EN 

11 

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the  power  to  adopt  acts  in  accordance  with  Article  290  of  the  Treaty  on  the 
Functioning of the European Union should be delegated to the Commission in respect 
of  amendments  to  the  amounts,  the  reductions,  the  methods  of  calculation  and  the 
performance information laid down in the Annex to this Regulation, notably through 
monitoring the inflation rate in the EU and in light of the experience acquired with the 
actual  application  of  this  Regulation.  It  is  of  particular  importance  that  the 
Commission carry out appropriate consultations during its preparatory work, including 
at  expert  level.  The  Commission,  when  preparing  and  drawing  up  delegated  acts, 
should  ensure  a  simultaneous,  timely  and  appropriate  transmission  of  relevant 
documents to the European Parliament and to the Council. 

(22)  Since  the  objective  of  this  Regulation,  namely  to  ensure  adequate  funding  of 
pharmacovigilance activities carried out at the level of the Union, cannot sufficiently 
be achieved by the Member States and can, by reason of the scale of the measure, be 
better achieved at Union level, the Union may adopt measures, in accordance with the 
principle  of  subsidiarity  as  set  out  in  Article  5  of  the  Treaty  on  European  Union.  In 
accordance  with  the  principle  of  proportionality,  as  set  out  in  that  Article,  this 
Regulation  does  not  go  beyond  what  is  necessary  in  order  to  achieve  that  objective. 

For  reasons  of  predictability,  legal  certainty  and  proportionality,  the  annual  flat  fee 
should be levied for the first time by 31 January or by 1 July, depending on the date of 
entry  into  force  of  this  Regulation.  The  fees  for  union-wide  pharmacovigilance 
procedures should be levied for the first time after a reasonable time period, following 
the entry into force of this Regulation, has elapsed.  

HAVE ADOPTED THIS REGULATION: 

Article 1 

Subject matter and scope 

1. 

2. 

3. 

4. 

This  Regulation  shall  apply  to  fees  for  pharmacovigilance  activities  relating  to 
medicinal products for human use authorised in the Union under Regulation (EC) No 
726/2004  and  Directive  2001/83/EC  which  shall  be  levied  by  the  European 
Medicines Agency (hereinafter the ‘Agency’) on marketing authorisation holders.  

This Regulation determines the activities performed at Union level for which fees are 
due,  the  amounts  and  the  rules  of  payment  of  those  fees  and  the  level  of 
remuneration of the rapporteurs. 

Micro  enterprises  within  the  meaning  of  Recommendation  2003/361/EC  shall  be 
exempted from any fee under this Regulation. 

The fees provided for in this Regulation shall apply without prejudice to the fees laid 
down in Council Regulation (EC) No 297/9520. 

For the purposes of this Regulation the following definitions shall apply: 

Article 2 

Definitions 

1. 

20 

EN 

'Chargeable  unit'  means  each  individual  entry  in  the  database  referred  to  in  Article 
57(1)(l)  of  Regulation  (EC)  No  726/2004  based  on  information  from  the  list  of  all 

OJ L 35, 15.2.1995, p. 1. 

12 

   EN 

 
                                                 
medicinal products for human use authorised in the Union referred to in Article 57(2) 
thereof. 

2. 

3. 

4. 

‘Medium  enterprise’  means  a  medium-sized  enterprise  within  the  meaning  of 
Recommendation 2003/361/EC; 

‘Small enterprise’ means a small enterprise within the meaning of Recommendation 
2003/361/EC; 

 ‘Micro enterprise’ means a micro enterprise within the meaning of Recommendation 
2003/361/EC. 

1. 

The fees for pharmacovigilance activities shall consist of the following: 

Article 3 

Types of fees 

2. 

1. 

2. 

3. 

4. 

5. 

6. 

(a) 

fees  for  Union-wide  procedures  as  provided  for  in  Articles  4,  5  and  6 
(hereinafter 'fees for procedures'); 

(b) 

an annual flat fee as provided for in Article 7. 

Where a fee is levied by the Agency in accordance with paragraph 1(a), the Agency 
shall  remunerate  the  rapporteur  in  the  Pharmacovigilance  Risk  Assessment 
Committee  appointed  by  the  Member  State  or  the  rapporteur  in  the  coordination 
group (hereinafter 'the rapporteur') for the work they carry out for the Agency or the 
coordination group. This remuneration shall be paid in accordance with Article 9.  

Article 4 

Fee for assessment of periodic safety update reports 

The  Agency  shall  levy  a  fee  for  the  assessment  of  periodic  safety  update  reports 
referred to in 107e and 107g of Directive 2001/83/EC and in Article 28 of Regulation 
(EC) No 726/2004.  

The amount of the fee is laid down in Part I of the Annex. 

Where only one marketing authorisation holder is subject to the obligation to submit 
a  periodic  safety  update  report  in  the  context  of  the  procedures  referred  to  in 
paragraph  1,  the  Agency  shall  levy  the  total  amount  of  the  applicable  fee  on  that 
marketing authorisation holder.  

Where  two  or  more  marketing  authorisation  holders  submit  periodic  safety  update 
reports in the context of the procedures referred to in paragraph 1, the Agency shall 
divide  the  total  amount  of  the  fee  among  those  marketing  authorisation  holders  in 
accordance with Part I of the Annex. 

Where the marketing authorisation holder referred to in paragraphs 3 and 4 is a small 
or  medium-sized  enterprise,  the  amount  payable  by  the  marketing  authorisation 
holder shall be reduced as laid down in Part I of the Annex. 

The Agency shall levy the fee under this Article by issuing a separate invoice to each 
marketing  authorisation  holder  concerned  within  thirty  calendar  days  from  the 
submission date of the periodic safety update report established in accordance with 
Article 107c(4) of Directive 2001/83/EC. Fees due under this Article shall be paid to 

EN 

13 

   EN 

 
the  Agency  within  thirty  calendar  days  from  the  date  on  which  the  invoice  is 
received by the marketing authorisation holder.  

Article 5 

Fee for assessment of post-authorisation safety studies 

The Agency shall levy a fee for post-authorisation safety studies referred to in Article 
21a(b) or  Article  22a(1)(a) of Directive  2001/83/EC and Article 9(4)(cb) or Article 
10a(1)(a)  of  Regulation  (EC)  No  726/2004  for  the  assessment  thereof  carried  out 
under Articles 107n to 107q of Directive 2001/83/EC and Article 28b of Regulation 
(EC) No 726/2004.  

The amount of the fee is laid down in Part II of the Annex. 

Where  the  obligation  to  conduct  a  post-authorisation  safety  study  referred  to  in 
paragraph 1 is imposed on more than one marketing authorisation holders, the same 
concerns  applying  to  more  than  one  medicinal  products,  and  where  the  marketing 
authorisation  holders  concerned  conduct  a  joint  post-authorisation  safety  study,  the 
amount payable by each marketing authorisation holder shall be levied as laid down 
in Part II section 3 of the Annex. 

Where  the  obligation  to  conduct  a  post-authorisation  safety  study  is  imposed  on  a 
marketing  authorisation  holder  which  is  a  small  or  medium-sized  enterprise,  the 
amount payable by the marketing authorisation holder shall be reduced, as laid down 
in Part II of the Annex.  

The  Agency  shall  levy  the  fee  under  this  Article  by  issuing  an  invoice  to  each 
marketing  authorisation  holder  within  thirty  calendar  days  from  the  receipt  of  the 
final study report by the Pharmacovigilance Risk Assessment Committee. Fees due 
under this Article shall be paid within thirty calendar days from the date on which the 
invoice is received by the marketing authorisation holder. 

Marketing authorisation holders who are charged the fee under this Article shall be 
exempted from any other fee charged by a competent authority for the submission of 
studies referred to in paragraph 1. 

Article 6 

Fee for assessments in the context of referrals initiated as a result of  
the evaluation of pharmacovigilance data 

The  Agency  shall  levy  a  fee  for  the  assessment  carried  out  in  the  context  of  a 
procedure  initiated  as  a  result  of  the  evaluation  of  pharmacovigilance  data  under 
Articles  107i  to  107k  of  Directive  2001/83/EC,  under  the  second  subparagraph  of 
Article 31(1) thereof or under Article 20(8) of Regulation (EC) No 726/2004. 

The amount of the fee is laid down in Part III of the Annex. 

Where only one marketing authorisation holder is involved in the procedure referred 
to in paragraph 1, the Agency shall levy the total amount of the fee on that marketing 
authorisation holder, as laid down in Part III of the Annex. 

1. 

2. 

3. 

4. 

5. 

6. 

1. 

2. 

3. 

EN 

14 

   EN 

 
 
4. 

5. 

6. 

1. 

2. 

3. 

4. 

5. 

6. 

Where  two  or  more  marketing  authorisation  holders  are  involved  in  the  procedure 
referred to in paragraph 1, the Agency shall divide the total amount of the fee among 
those marketing authorisation holders in accordance with Part III of the Annex. 

Where the marketing authorisation holder referred to in paragraphs 2 or 3 is a small 
or  medium-sized  enterprise,  the  amount  payable  by  that  marketing  authorisation 
holder shall be reduced as laid down in Part III of the Annex. 

The Agency shall levy the fee under this Article by issuing a separate invoice to each 
marketing authorisation holder involved in the procedure within thirty calendar days 
from the public announcement of the procedure in accordance with Article 107j(1) of 
Directive  2001/83/EC  or  from  the  date  on  which  the  matter  was  referred  to  the 
Agency under the second subparagraph of Article 31(1) of Directive 2001/83/EC or 
under  Article  20(2)  of  Regulation  (EC)  No  726/2004.  Fees  due  under  this  Article 
shall  be  paid  within  thirty  calendar  days  from  the  date  on  which  the  invoice  is 
received by the marketing authorisation holder. 

Article 7 

Annual flat fee 

For its pharmacovigilance activities relating to information technology systems under 
Article 24, Article 25a, Article 26, Article 57(1)(l) of Regulation (EC) No 726/2004, 
monitoring  of  selected  medical  literature  under  Article  27  thereof  and  signal 
detection under Article 28a thereof, the Agency shall levy once per year a flat fee as 
laid down in Part IV of the Annex.  

The  fee  shall  be  levied  on  holders  of  marketing  authorisations  for  all  medicinal 
products  authorised  in  the  Union  in  accordance  with  Directive  2001/83/EC,  on  the 
basis  of  the  chargeable  units  corresponding  to  those  products.  Chargeable  units 
in  accordance  with  Regulation  (EC) 
corresponding 
fee. 
No 726/2004 

to  products  authorised 
shall 

subject 

annual 

flat 

not 

the 

be 

to 

The  total  annual  payable  amount  for  each  marketing  authorisation  holder  shall  be 
calculated  by  the  Agency  on  the  basis  of  the  chargeable  units  as  defined  in  Article 
2(1) of this Regulation which correspond to the information recorded on 1 January of 
each year. This amount shall cover the period from 1 January to 31 December of that 
year.  

The amount of the annual flat fee per chargeable unit is laid down in Part IV of the 
Annex. 

Where the marketing authorisation holder is a small or medium-sized enterprise, the 
amount payable by the marketing authorisation holder shall be reduced as laid down 
in Part IV of the Annex. 

A  reduced  annual  flat  fee,  as  laid  down  in  Part  IV  of  the  Annex,  shall  apply  in 
respect of medicinal products referred to in Article 10(1) and Article 10a of Directive 
2001/83/EC  and  in  respect  of  authorised  homeopathic  medicinal  products  and 
authorised  herbal  medicinal  products,  as  defined  respectively  in  Article  1(5)  and 
Article 1(30) of Directive 2001/83/EC.  

Where  the  marketing  authorisation  holder  of  medicinal  products  referred  to  in 
paragraph  4  is  a  small  or  medium-sized  enterprise,  only  the  reduction  set  out  in 
paragraph 3 shall apply. 

EN 

15 

   EN 

 
7. 

The  Agency  shall  levy  the  annual  flat  fee  by  issuing  invoices  to  marketing 
authorisation  holders  at  the  latest  on  31  January  of  every  calendar  year  for  that 
calendar year. Fees due under this Article shall be paid within 30 calendar days from 
the date on which the invoice is received by the marketing authorisation holder. 

8. 

The Agency shall retain the fee revenue from the annual flat fee. 

1. 

2. 

3. 

4. 

5. 

Article 8 

Fee reductions and exemptions 

Any  marketing  authorisation  holder  claiming  to  be  a  small  or  medium-sized 
enterprise and, therefore, to be entitled to a reduced fee under Articles 4 to 7, shall 
make  a  declaration  to  that  effect  to  the  Agency  within  30  calendar  days  from  the 
receipt of the invoice from the Agency. The Agency shall apply the reduction on the 
basis of that declaration where the required conditions are met. 

Any  marketing  authorisation  holder  claiming  to  be  a  micro  enterprise  and  to  be 
entitled to the exemption under Article 1 shall make a declaration to that effect to the 
Agency  within  30  calendar  days  from  the  receipt  of  the  invoice  from  the  Agency. 
The Agency shall apply the exemption on the basis of that declaration. 

Any marketing authorisation holder claiming to be entitled to a reduced annual flat 
fee  under  Article  7(5)  shall  make  a  declaration  to  that  effect  to  the  Agency.  The 
Agency shall apply the reduction on the basis of that declaration where the required 
conditions  are  met.  Where  the  declaration  is  made  by  the  marketing  authorisation 
holder after the receipt of the invoice from the Agency, the declaration shall be done 
within 30 calendars days from the receipt of that invoice. 

The Agency may request, at any time, evidence that the conditions for a reduction of 
fees  or  for  an  exemption  from  fees  are  fulfilled.  In  that  case,  the  marketing 
authorisation  holder  claiming  or  having  claimed  to  be  entitled  to  a  reduction  or  an 
exemption  under  this  Regulation,  shall  submit  to  the  Agency  the  information 
necessary to demonstrate compliance with the relevant conditions. 

Where a marketing authorisation holder claiming or having claimed to be entitled to 
a reduction of or an exemption from fees under this Regulation fails to demonstrate 
that it is entitled to such a reduction or exemption, the amount of the fee laid down in 
the  Annex  shall  be  increased  by  10%  and  the  Agency  shall  levy  the  resulting  full 
applicable  amount  or,  as  appropriate,  the  balance  to  the  resulting  full  applicable 
amount.  

Payment of remuneration by the Agency to rapporteurs 

Article 9 

1. 

The  Agency  shall  remunerate  rapporteurs  in  accordance  with  Article  3(2)  in  the 
following cases: 

(c)  where  the  Member  State  has  appointed  a  member  of  the  Pharmacovigilance 
Risk  Assessment  Committee  who  acts  as  rapporteur  for  the  assessment  of 
periodic safety update reports referred to in Article 4;  

(d)  where  the  Member  State  has  appointed  a  representative  in  the  coordination 
group who acts as rapporteur in the context of the assessment of periodic safety 
update reports referred to in Article 4;  

EN 

16 

   EN 

(e)  where  the  Member  State  has  appointed  a  member  of  the  Pharmacovigilance 
Risk Assessment Committee who acts as rapporteur for the assessment of post-
authorisation safety studies referred to in Article 5; 

(f)  where  the  Member  State  has  appointed  a  member  of  the  Pharmacovigilance 
Risk Assessment Committee who acts as rapporteur for the referrals referred to 
in Article 6. 

Where the Pharmacovigilance Risk Assessment Committee or the coordination group 
decides  to  appoint  a  co-rapporteur,  the  remuneration  shall  be  divided  between  the 
rapporteur and the co-rapporteur. 

The  corresponding  amounts  of  the  remuneration  for  each  of  the  activities  listed  in 
paragraph 1 are laid down in Parts I, II and III of the Annex.  

The  remuneration  provided  for  in  paragraph  1  shall  be  paid  only  after  the  final 
assessment  report  for  a  recommendation  which  is  intended  for  adoption  by  the 
Pharmacovigilance  Risk  Assessment  Committee  has  been  made  available  to  the 
Agency. 

The remuneration provided for in paragraph 1 for the work of the rapporteur and any 
related scientific and technical support shall be without prejudice to the obligation of 
Member  States  not  to  give  committee  members  and  experts  instructions  which  are 
incompatible  with  their  own  individual  tasks  as  rapporteur  or  with  the  tasks  and 
responsibilities of the Agency. 

The remuneration shall be paid in accordance with the written contract referred to in 
the  first subparagraph of Article 62(3) of Regulation (EC) No  726/2004.  Any bank 
charges related to the payment of that remuneration shall be borne by the Agency. 

Article 10 

Mode of payment of the fee 

The fees shall be paid in Euro. 

Payments shall be made only after the marketing authorisation holder has received an 
invoice issued by the Agency. 

Payments shall be made by means of a transfer to the bank account of the Agency. 
Any  bank  charges  related  to  the  payment  shall  be  borne  by  the  marketing 
authorisation holder. 

Article 11 

Identification of the payment of the fee 

In  every  payment  the  marketing  authorisation  holder  shall  indicate  the  remittance 
reference.  For  payments  made  by  on-line  payment  system,  the  reference  number 
generated is regarded as remittance number. 

If the purpose of the payment cannot be established, the Agency shall set a deadline 
by which the marketing authorisation holder shall notify it in writing of the purpose 
of the payment. If the Agency does not receive a notification of the purpose of the 
payment before expiry of the deadline, the payment shall be considered invalid and 
the amount concerned shall be refunded to the marketing authorisation holder. 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

1. 

2. 

EN 

17 

   EN 

Article 12 

Date of payment of the fee 

The date on which the full amount of the payment is received in the bank account held by the 
Agency shall be considered to be the date on which the payment has been made. A deadline 
for payment shall be considered to have been observed only if the full amount of the fee has 
been paid in due time. 

Article 13 

Refund of fee amounts paid in excess 

1. 

2. 

Excess  amounts  shall  be  refunded  by  the  Agency  to  the  marketing  authorisation 
holder.  However,  where  an  amount  paid  in  excess  is  under  EUR  100  and  the 
marketing  authorisation  holder  concerned  has  not  expressly  requested  a  refund,  the 
amount paid in excess shall not be refunded. 

It shall not be possible to count any amounts paid in excess towards future payments 
to the Agency. 

Article 14 

Provisional estimate of Agency budget 

The Agency shall, when producing an estimate of the overall expenditure and income for the 
following  financial  year  in  accordance  with  Article  67(6)  of  Regulation  (EC)  No  726/2004, 
include  detailed  information  on  income  from  fees  relating  to  pharmacovigilance  activities. 
This information shall distinguish between the annual flat fee and the fees for each procedure 
referred to in Article 3(a). The Agency shall also provide specific analytical information on its 
revenue  and  expenditure  related  to  pharmacovigilance  activities,  allowing  to  distinguish 
between the annual flat fee and each of the fees for procedures referred to in Article 3(a).  

Article 15 

Transparency and monitoring 

1. 

2. 

3. 

4. 

The amounts and rates laid down in Parts I to IV of the Annex shall be published on 
the website of the Agency.  

The  Executive  Director  of  the  Agency  shall  provide  the  Commission  and  the 
Management  Board  annually  with  information  on  the  components  that  may  have  a 
bearing on the costs to be covered by the fees provided for in this Regulation. This 
information shall include a cost breakdown related to the previous year and a forecast 
for the following year. The Executive Director of the Agency shall also provide the 
Commission  and  the  Management  Board  once  per  year  with  the  performance 
information  set  out  in  Part  V  of  the  Annex  based  on  the  performance  indicators 
referred to in paragraph 3. 

Within one year from the entry into force of this Regulation, the Agency shall adopt 
a set of performance indicators taking into account the information listed in Part V of 
the Annex. 

The inflation rate as measured by means of the European Index of Consumer prices 
as published by Eurostat pursuant to Regulation (EC) No 2494/95 shall be monitored 
in relation to the amounts set out in the Annex. The monitoring shall take place for 

EN 

18 

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5. 

1. 

2. 

1. 

2. 

3. 

4. 

5. 

the first time after this Regulation has been applied during a full calendar year and, 
thereafter, annually.  

In  view  of  the  monitoring  referred  to  in  paragraph  4,  the  Commission  may,  where 
necessary,  adjust  the  amounts  of  the  fees  and  the  amounts  of  the  remuneration  of 
rapporteurs  laid  down  in  the  Annex,  in  accordance  with  Article  16.  Those 
adjustments  shall  take  effect  on  1  April  following  the  entry  into  force  of  the 
corresponding amending act. 

Article 16 

Amendment  

The Commission shall be empowered to adopt delegated acts to amend Parts I to V 
of the Annex. 

Any amendments to the amounts shall be based on an evaluation of the costs of the 
Agency and the costs of the assessments provided by the rapporteurs as laid down in 
Article 9 or on the monitoring of the inflation rate referred to in Article 15(4). 

Article 17 

Exercise of the delegation 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

The power to adopt delegated acts referred to in Article 16 shall be conferred on the 
Commission for an indeterminate period of time from [*]. 

The delegation of powers referred to in Article 16 may be revoked at any time by the 
European Parliament and by the Council. A decision to revoke shall put an end to the 
delegation  of  the  power  specified  in  that  decision.  It  shall  take  effect  the  day 
following  the  publication  of  the  decision  in  the  Official  Journal  of  the  European 
Union  or  at  the  later  date  specified  therein.  It  shall  not  affect  the  validity  of  any 
delegated acts already in force. 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

A  delegated  act  adopted  pursuant  to  Article  16  shall  enter  into  force  only  if  no 
objection  has  been  expressed  either  by  the  European  Parliament  or  the  Council 
within a period of two months of notification of that act to the European Parliament 
and the Council or if, before the expiry of that period, the European Parliament and 
the  Council  have  both  informed  the  Commission  that  they  will  not  object.  That 
period shall be extended by two months at the initiative of the European Parliament 
and the Council. 

[*] 

Date of entry into force of the basic legislative act or any other date set by the legislator.[To be adapted 
by the legislator]  

EN 

19 

   EN 

                                                 
Article 18 

Transitional provisions 

The fees referred to in Articles 4, 5 and 6 and Parts I, II and III of the Annex shall 
not  apply  to  those  procedures  at  Union  level  which  are  initiated  before  the  fortieth 
day following the entry into force of this Regulation. 

Article 19 

Entry into force and application 

1. 

2. 

This  Regulation  shall  enter  into  force  on  the  twentieth  day  following  that  of  its 
publication in the Official Journal of the European Union. 

The annual flat fee referred to in Article 7 and specified in Part IV of the Annex shall 
be levied for the first time by [31 January or by 1 July following the entry into force 
of  this  Regulation  whichever  date  is  the  earliest],  and  by  31  January  every  year 
thereafter. [In case the annual flat fee is levied for the first time on 1 July, 50 % of 
the full flat fee shall be levied.][To be adapted by the legislator] 

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

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

EN 

20 

   EN 

ANNEX 

PART I 

Fee for assessment of periodic safety update reports referred to in Article 4: amounts 
levied by the Agency and level of remuneration of rapporteurs 

1. 

2. 

3. 

4. 

The  fee  for  the  assessment  of  periodic  safety  update  reports  is  EUR  19 500  per 
procedure. The corresponding remuneration of the rapporteur is EUR 13 100. 

In application of Article 4(5), small and medium-sized enterprises shall pay 60 % of 
the applicable amount.  

For  the  purpose  of  calculating  the  amount  to  be  levied  on  each  marketing 
authorisation  holder  in  application  of  Article  4(4),  the  Agency  shall  calculate  the 
proportion  of  chargeable  units  held  by  each  marketing  authorisation  holder 
concerned of the total number of chargeable units held by all marketing authorisation 
holders involved in the procedure. 

The share payable by each marketing authorisation holder shall be calculated by: 

(i)  dividing  the  total  amount  of  the  fee  among  the  marketing  authorisation  holders 
concerned proportionately to the number of chargeable units,  

(ii)  subsequently  applying  the  reduction  as  per  paragraph  2  of  Part  I  of  this  Annex 
and the exemption referred to in Article 1(3), where relevant. 

Where reductions and exemptions apply, the remuneration of the rapporteur shall be 
adapted  proportionally.  Where  the  Agency  subsequently  collects  the  full  applicable 
amount including the 10 % increase as provided for in Article 8(5), the remuneration 
of the rapporteur shall be adapted proportionally. 

PART II 

Fee for assessment of a post-authorisation safety study referred to in Article 5: amounts 
levied by the Agency and level of remuneration rapporteurs 

1. 

2. 

3. 

4. 

The fee for the assessment of a post authorisation safety study is EUR 43 000. The 
corresponding remuneration of the rapporteur is EUR 18 200.  

In application of Article 5(4), small and medium-sized enterprises shall pay 60 % of 
the applicable amount.  

Where marketing authorisation holders concerned conduct a joint post-authorisation 
safety  study  referred  to  in  Article  5(3),  the  amount  payable  by  each  marketing 
authorisation  holder  shall  be  levied  by  the  Agency  by  evenly  dividing  the  total 
amount of the fee among those marketing authorisation holders. Where relevant, the 
reduction laid down in paragraph 2 of Part II of this Annex or, where appropriate, the 
exemption  referred  to  in  Article  1(3),  shall  be  applied  to  the  share  payable  by  the 
marketing authorisation holder. 

Where reductions and exemptions apply, the remuneration of the rapporteur shall be 
adapted  proportionally.  Where  the  Agency  subsequently  collects  the  full  applicable 
amount including the 10 % increase as provided for in Article 8(5), the remuneration 
of the rapporteur shall be adapted proportionally. 

EN 

21 

   EN 

PART III 

Fee for assessment in the context of referrals initiated as a result of the evaluation of 
pharmacovigilance data referred to in Article 6: amounts levied by the Agency and level 
of remuneration of rapporteurs 

1. 

2. 

3. 

1. 

2. 

3. 

The  fee  for  the  assessment  of  the  procedure  referred  to  in  Article  6(1)  is  EUR 
168 600. The corresponding remuneration of the rapporteur is EUR 45 100. 

In application of Article 6(5), small and medium-sized enterprises shall pay 60 % of 
the applicable amount.  

For  the  purpose  of  calculating  the  amount  to  be  levied  on  each  marketing 
authorisation  holder  in  application  of  Article  6(4),  the  Agency  shall  calculate  the 
proportion  of  chargeable  units  held  by  each  marketing  authorisation  holder 
concerned of the total number of chargeable units held by all marketing authorisation 
holders involved in the procedure. 

The amount payable by each marketing authorisation holder shall be calculated by: 

(i)  dividing  the  total  amount  of  the  fee  among  the  marketing  authorisation  holders 
concerned proportionately to the number of chargeable units,  

(ii)  subsequently  applying  the  reduction  laid  down  in  paragraph  2  of  Part  II  of  this 
Annex and the exemption referred to in Article 1(3), where relevant. 

Where reductions and exemptions apply, the remuneration of the rapporteur shall be 
adapted  proportionally.  Where  the  Agency  subsequently  collects  the  full  applicable 
amount including the 10 % increase as provided for in Article 8(5), the remuneration 
of the rapporteur shall be adapted proportionally. 

PART IV 

Annual flat fee referred to in Article 7 

The annual flat fee is EUR 60 per chargeable unit.  

In application of Article 7(4), small and medium-sized enterprises shall pay 60 % of 
the applicable amount.  

Holders of marketing authorisations for medicinal products referred to in Article 7(5) 
shall  pay  80  %  of  the  amount  applicable  to  the  chargeable  units  corresponding  to 
those products. 

EN 

22 

   EN 

PART V 

Performance information 

The following information shall relate to each calendar year:  

Number  of  Agency  staff  involved  in  pharmacovigilance  activities  as  per  the  legislation 
applicable during the reference period, specifying staff allocated to activities corresponding to 
each of the fees referred to in Articles 4 to 7.  

Number of hours outsourced to third parties with specification of the activities concerned and 
cost incurred. 

Overall  pharmacovigilance  costs  and  a  breakdown  of  staff  and  non-staff  costs  relating  to 
activities corresponding to each of the fees referred to in Articles 4 to 7. 

Number of procedures relating to the assessment of periodic safety update reports, as well as 
number  of  marketing  authorisation  holders  and  number  of  chargeable  units  per  procedure; 
number  of  reports  submitted  per  procedure  and  number  of  marketing  authorisation  holders 
that have submitted a joint periodic safety update report. 

Number of procedures relating to the assessment of post-authorisation safety studies; number 
of marketing authorisation holders having carried out such studies and number of marketing 
authorisation holders that have submitted a joint study. 

Number of procedures relating to the referrals initiated on the basis of pharmacovigilance data 
as  well  as  number  of  marketing  authorisation  holders  and  number  of  chargeable  units 
involved per marketing authorisation holder and per procedure. 

Number  of  marketing  authorisation  holders  that  have  claimed  a  small  and  medium-sized 
enterprise  status  involved  in  each  procedure;  number  of  marketing  authorisation  holders 
whose claim has been denied. 

Number  of  marketing  authorisation  holders  that  have  claimed  a  micro  enterprise  status; 
number of marketing authorisation holders whose claim for fee exemption has been denied.  

Number of marketing authorisation holders of medicinal products referred to in Article 7(5) 
that have benefitted from reduced annual flat fees; number of chargeable units per marketing 
authorisation holders concerned.  

Number of invoices sent out/ annual fees charged in respect of the annual flat fee and average 
and overall amount invoiced to marketing authorisation holders.  

Number  of  marketing  authorisation  holders  that  have  claimed  a  small  and  medium-sized 
enterprise  or  a  micro  enterprise  status  for  each  annual  application  of  the  annual  flat  fee; 
number of marketing authorisation holders whose claim has been denied. 

Attribution of rapporteurships and co-rapporteurships per Member State per type of procedure 

EN 

23 

   EN 

LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on  fees  payable  to  the  European  Medicines  Agency  (EMA)  for  the  conduct  of 
pharmacovigilance activities in respect of medicinal products for human use 
Policy area(s) concerned in the ABM/ABB structure21 

1.2. 

Public Health (Heading 3B of MFF) 

1.3. 

Nature of the proposal/initiative  

(cid:133) The proposal/initiative relates to a new action  

(cid:133)  The  proposal/initiative  relates  to  a  new  action  following  a  pilot  project/preparatory 
action22 

(cid:59) The proposal/initiative relates to the extension of an existing action  

(cid:133) The proposal/initiative relates to an action redirected towards a new action  

1.4. 

Objectives 

1.4.1.  The  Commission's  multiannual 

strategic  objective(s) 

targeted  by 

the 

proposal/initiative  

Resource-efficient, smart and inclusive growth. 

1.4.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned  

Specific objective No 

Ensure  proper  implementation  of  measures  to  monitor  safety  of  medicines  through 
implementation at the level of the Union of the pharmacovigilance legislation of the 
Union 

ABM/ABB activity(ies) concerned 

Public Health (Heading 3B of MFF) 

21 
22 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 

EN 

24 

   EN 

                                                 
1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

The  main  effect  is  the  introduction  of  fees  to  be  paid  by  marketing  authorisation 
holders of medicinal products for  human  use for  the  conduct of  pharmacovigilance 
activities  by  the  European  Medicines  Agency  as  per  the  applicable  legislation, 
including scientific assessment performed by rapporteurs in the framework of Union-
wide pharmacovigilance procedures. 

The  expected  impact  on  the  EMA  is  to  be  able  to  collect  fees  to  ensure  adequate 
financing in order to cover the estimated cost for the conduct of pharmacovigilance 
activities as assigned to it by the 2010 legislation on pharmacovigilance that became 
applicable in July 2012. 

Marketing  authorisation  holders  (MAH)  are  proposed  to  be  charged  a  fee  per 
procedure when involved in one of the Union-wide pharmacovigilance procedures. It 
is  also  proposed  that  all  MAH  of  medicinal  products  for  human  use  with  a  valid 
authorisation  be  charged  a  flat-rate  fee  for  general  pharmacovigilance  activities  of 
the  EMA,  as  assigned 
legislation  on 
the  Agency  by 
pharmacovigilance. 

the  applicable 

to 

It  is  proposed  that  rapporteurs  from  the  national  competent  authorities  be 
remunerated  for  the  assessment  services  that  that  provide  in  the  framework  of  the 
Union-wide  pharmacovigilance  procedures.  This  remuneration,  based  on  average 
cost estimations, is included in the proposed fees. 

1.4.4. 

Indicators of results and impact  

Specify the indicators for monitoring implementation of the proposal/initiative. 

The  monitoring  will  be  related  to  the  implementation  of  the  annual  budget  of  the 
EMA.  The  annual  activity  report  on  the  performance  of  the  EMA  will  provide 
reliable performance information as provided for in the proposed Regulation and key 
indicators such as:  

– 

– 

– 

– 

the  actual  number  of  Union-wide  pharmacovigilance  procedures  and  their 
qualitative content, 

the  amount  of  actual  cost  for  each  type  of  procedure  and  for  general 
pharmacovigilance activities, 

the minimum, maximum and average number of marketing authorisations and 
marketing  authorisation  holders  (MAH)  per  procedure,  as  well  as  other 
indicators such as ranges representing a high percentage of the cases, 

the annual fee revenue per procedure and the annual fee revenue from the flat 
fee. 

Based on data on actual cost and fee revenue, the Commission may consider whether 
there is a need to revise the fees, after experience has been gained. 

EN 

25 

   EN 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term  

The  new  pharmacovigilance  legislation  is  already  applicable  and  it  foresees  that 
pharmacovigilance activities be financed through new fees. The proposed legislation 
will  only  deal  with  fees  for  EMA  (and  not  fees  charged  by  national  competent 
authorities for which the Union is not competent).  

1.5.2.  Added value of involvement of the Union 

The  European  Medicines  Agency  is  a  European  decentralised  Agency  set  up  by 
Regulation (EC) No 726/2004. Hence, decisions on its funding are to be taken at the 
level  of  the  Union.  Only  the  Union  can  act  to  introduce  these  fees  for 
pharmacovigilance.  

1.5.3.  Lessons learned from similar experiences in the past 

Feedback  from  public  consultation  that  took  place  from  18  June  2012  to  15 
September 2012 indicated that fees for pharmacovigilance should be cost-based and 
as much as possible follow the principle of payment for service. 

1.5.4.  Compatibility and possible synergy with other appropriate instruments 

The  proposed  Regulation  will  apply  in  parallel  to  the  existing  Council  Regulation 
(EC)  No  297/95  on  fees  payable  to  the  EMA  for  the  Evaluation  of  Medicinal 
Products.  

EN 

26 

   EN 

1.6. 

Duration and financial impact  

(cid:133) Proposal/initiative of limited duration  

(1)  (cid:133) Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

(2)  (cid:133) Financial impact from YYYY to YYYY  

(cid:59) Proposal/initiative of unlimited duration 

– 

– 

Implementation with a start-up period from YYYY to YYYY, 

followed by full-scale operation. 

1.7.  Management mode(s) envisaged23  

(cid:133) Centralised direct management by the Commission  

(cid:59)  Centralised  indirect  management  with  the  delegation  of  implementation  tasks 
to: 

–  (cid:133) executive agencies 
–  (cid:59) bodies set up by the Communities24 

–  (cid:133) national public-sector bodies/bodies with public-service mission 

(3)  (cid:133)  persons  entrusted  with  the  implementation  of  specific  actions  pursuant  to 
Title V of the Treaty on European Union and identified in the relevant basic act 
within the meaning of Article 49 of the Financial Regulation 

(cid:133) Shared management with the Member States  

(cid:133) Decentralised management with third countries  

(cid:133) Joint management with international organisations (to be specified) 

If more than one management mode is indicated, please provide details in the "Comments" section. 

23 

24 

Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the 
BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 
As referred to in Article 185 of the Financial Regulation. 

EN 

27 

   EN 

                                                 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

The Agency will provide the Commission and the Management Board twice per year 
with  detailed  and  aggregated  performance  information  and  indicators  relating  to 
pharmacovigilance activities and fees. 

2.2.  Management and control system  

2.2.1.  Risk(s) identified  

Insufficient  fee  income,  given  the  difficulty  to  predict  the  exact  actual  frequency, 
scope  and  cost  of  all  the  Union-wide  pharmacovigilance  procedures  and  activities 
occurring in a given year.  

Incomplete collection of invoiced fees. 

2.2.2.  Control method(s) envisaged  

Regular monitoring and reporting from the Agency to the Commission on the level 
of  performance,  the  level  of  collection  of  fees  and  unitary  and  aggregated  cost-
related components relevant to the estimation of fee levels. 

2.2.3.  Costs and benefits of controls and probable non-compliance rate 

Administrative procedures of the Agency will be set up so that existing monitoring 
tables,  cost-account  tables  and  activity-based  system  provide  information  on  cost 
breakdown of procedures and activities that will be funded by the fees set up by this 
Regulation. 

2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

In  addition  to  the  application  of  all  regulatory  control  mechanisms,  the  responsible 
Commission's  services  will  devise  an  anti-fraud  strategy  in  line  with  the 
Commission's anti-fraud strategy (CAFS) adopted on 24 June 2011 in order to ensure 
inter alia that its internal anti-fraud related controls are fully aligned with the CAFS 
and that its fraud risk management approach is geared to identify fraud risk areas and 
adequate  responses.  Where  necessary,  networking  groups  and  adequate  IT  tools 
dedicated to analysing fraud cases related to the financing implementing activities of 
this Regulation will be set up. In particular a series of measures will be put in place 
such as:  

– 

– 

decisions, agreements and contracts resulting from the financing implementing 
activities  of  this  Regulations  will  expressly  entitle  EMA,  the  Commission, 
including  OLAF,  and  the  Court  of  Auditors  to  conduct  audits,  on-the-spot 
checks and inspections; 

regular training on issues related to fraud and irregularities is given to all staff 
involved in fee and contract management as well as to auditors and controllers. 

EN 

28 

   EN 

3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

– 

Existing budget lines  

In order of multiannual financial framework headings and budget lines. 

Heading of 
multiannual 
financial 
framework 
3 

Budget line 

Number 17.0310* 
Subsidy to the European Medicines 
Agency 

Type of  
expenditure

Diff./non-
diff.25 

Contribution  

from 
EFTA 
countries
26 

from 
candidate 
countries27 

from third 
countries 

within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  

[XX.YY.YY.YY] 

non-diff.

YES 

NO 

NO 

NO 

*17.0312 as from 01/01/2014 

– 

New budget lines requested N/A 

In order of multiannual financial framework headings and budget lines. 

Heading of 
multiannual 
financial 
framework  Number  

[Heading…………………………………..]

Budget line 

Type of 
expenditure 

Contribution  

Diff./non-
diff. 

from EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the 
meaning of 
Article 
18(1)(aa) of 
the Financial 
Regulation  

[XX.YY.YY.YY] 

YES/NO  YES/NO  YES/NO  YES/NO 

* The annual subsidy to the EMA is paid under this budget line. However, all 
pharmacovigilance activities under this proposal are considered to be fee-financed. 
Consequently, no impact is foreseen on the budget of the Union.

25 
26 
27 

Diff. = Differentiated appropriations / Non-Diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association. 
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 

EN 

29 

   EN 

 
 
 
 
 
 
 
 
                                                 
3.2. 

Estimated impact on expenditure  

This  part  must  be  completed  on  the  spreadsheet  on  budget  data  of  an  administrative  nature  (second  document  in  the  annex  to  this 
financial statement) to be uploaded to CISNET for interdepartmental consultation purposes. 

3.2.1. 

Summary of estimated impact on expenditure : N/A 

EUR million (to three decimal places) 

Heading of multiannual financial 
framework:  

Number 

[Heading 
……………...……………………………………………………………….] 

Year 
N28 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as 
necessary to show the duration 
of the impact (see point 1.6) 

TOTAL 

DG: <…….> 

(cid:121) Operational appropriations  

Number of budget line 

Number of budget line 

Commitments 
Payments 
Commitments 
Payments 

(1) 

(2) 

(1a) 

(2a) 

Appropriations  of  an  administrative  nature  financed  from  the 
envelope of specific programmes29 

Number of budget line 

TOTAL appropriations 
for DG <…….> 

Commitments 

Payments 

(3) 

=1+1a 
+3 

=2+2a 

+3 

28 
29 

EN 

Year N is the year in which implementation of the proposal/initiative starts. 
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former 'BA' lines), indirect research, 
direct research. 

30 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121) TOTAL operational appropriations  

Commitments 
Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(4) 

(5) 

(6) 

TOTAL appropriations  
under HEADING <….> 
of the multiannual financial framework 

Commitments 

=4+ 6 

Payments 

=5+ 6 

If more than one heading is affected by the proposal / initiative: 
(cid:121) TOTAL operational appropriations  

(4) 

Commitments 
Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial framework 
(Reference amount) 

Commitments 

Payments 

(5) 

(6) 

=4+ 6 

=5+ 6 

EN 

31 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial  
framework  

5 

‘Administrative expenditure’ 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  

TOTAL 

EUR million (to three decimal places) 

DG: <…….> 

(cid:121) Human resources 
(cid:121) Other administrative expenditure  

TOTAL DG <…….> 

Appropriations  

TOTAL appropriations 
for HEADING 5 
of the multiannual financial framework  

(Total  commitments  = 
Total payments) 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework  

Commitments 

Payments 

Year 
N30 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as 
necessary to show the duration 
of the impact (see point 1.6) 

TOTAL 

EUR million (to three decimal places) 

30 

Year N is the year in which implementation of the proposal/initiative starts. 

EN 

32 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.2.  Estimated impact on operational appropriations  

–  (cid:59) The proposal/initiative does not require the use of operational appropriations  

–  (cid:133) The proposal/initiative requires the use of operational appropriations, as explained below: 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as necessary to show the 
duration of the impact (see point 1.6)) 

TOTAL 

OUTPUTS 

Commitment appropriations in EUR million (to three decimal places) 

Indicate 
objectives and 
outputs  

(cid:216) 

Type31 

r
Avera
e
b
ge 
m
u
cost  N

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

l
a
t
o
T

r
e
b
m
u
N

Total 
Cost 

SPECIFIC OBJECTIVE No 132… 

- Output 

- Output 

- Output 

Subtotal for specific objective n° 1 

SPECIFIC OBJECTIVE n° 2… 

- Output 

Subtotal for specific objective n° 2 

TOTAL COST 

31 
32 

Outputs are products and services to be supplied (e.g.: number of student exchanges finances, number of km of roads built, etc.). 
As described in point 1.4.2. 'Specific objective(s)…'. 

EN 

33 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.  Estimated impact on appropriations of an administrative nature  

3.2.3.1.  Summary  

–  (cid:59) The  proposal/initiative  does  not  require  the  use  of  appropriations  of  an 

administrative nature  

–  (cid:133) The  proposal/initiative 

requires 

the  use  of  appropriations  of  an 

administrative nature, as explained below: 

EUR million (to three decimal places) 

Year 
N33 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as necessary to show the 
duration of the impact (see point 1.6) 

TOTAL 

HEADING 5 
of the multiannual 
financial framework 

Human resources  

Other 
expenditure  

administrative 

Subtotal HEADING 5 
of the multiannual 
financial framework  

Outside HEADING 534 of 
the multiannual financial 
framework  

Human resources  

Other 
of 
an 
nature 

expenditure  
administrative 

Subtotal  
outside HEADING 5 
of the multiannual 
financial framework  

TOTAL 

The  administrative  appropriations  required  will  be  met  by  the  appropriations  of  the  DG  which  are  already  assigned  to 
management  of  the  action  and/or  which  have  been  redeployed  within  the  DG,  together  if  necessary  with  any  additional 
allocation  which  may  be  granted  to  the  managing  DG  under  the  annual  allocation  procedure  and  in  the  light  of budgetary 
constraints.

33 
34 

Year N is the year in which implementation of the proposal/initiative starts. 
Technical  and/or  administrative  assistance  and  expenditure  in  support  of  the  implementation  of  EU 
programmes and/or actions (former 'BA' lines), indirect research, direct research. 

EN 

34 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.2.   Estimated requirements of human resources N/A 

–  (cid:133) The proposal/initiative does not require the use of human resources.  

–  (cid:133) The proposal/initiative requires the use of human resources, as explained below: 

Year 
N 

Year 
N+1 

Estimate to be expressed in full time equivalent units 

Year N+2 

Year N+3 

Enter as 
many years 
as necessary 
to show the 
duration of 
the impact 
(see point 
1.6) 

(cid:121) Establishment plan posts (officials and temporary agents) 

XX 01 01 01 (Headquarters and Commission’s Representation Offices) 
XX 01 01 02 (Delegations) 
XX 01 05 01 (Indirect research) 
10 01 05 01 (Direct research) 

(cid:121) External personnel (in Full Time Equivalent unit: FTE)35 

XX 01 02 01 (CA, INT, SNE from the "global envelope") 
XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations) 
XX 01 04 yy36 

- at headquarters 

- in delegations  

XX 01 05 02 (CA, SNE, INT - Indirect research) 

10 01 05 02 (CA, SNE, INT - Direct research) 

35 

36 

EN 

CA= Contract Agent; LA = Local Agent; SNE = Seconded National Expert; INT = agency staff ('Intérimaire'); JED = 'Jeune Expert en Délégation' (Young Experts 
in Delegations). 
Sub-ceiling, for external staff covered by operational appropriations (former "BA" lines). 

35 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Other budget lines (specify) 
TOTAL 

XX is the policy area or budget title concerned. 

The  human  resources  required will  be  met  by  staff  from  the  DG  who  are  already assigned  to management  of the  action  and/or  have been  redeployed  within  the  DG,  together  if 
necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints. 

Description of tasks to be carried out: 

Officials and temporary staff 

External staff 

EN 

36 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.4.  Compatibility with the current multiannual financial framework  

–  (cid:59) Proposal/initiative 

is  compatible 

the  current  multiannual 

financial 

framework. 

–  (cid:133) Proposal/initiative will entail reprogramming of the relevant heading in the 

multiannual financial framework. 

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts. 

[…] 

–  (cid:133) Proposal/initiative  requires  application  of  the  flexibility  instrument  or 

revision of the multiannual financial framework.37 

Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts. 

[…] 

3.2.5.  Third-party contributions  

–  (cid:59) The proposal/initiative does not provide for co-financing by third parties.  

–  (cid:133) The proposal/initiative provides for the co-financing estimated below: 

Appropriations in EUR million (to three decimal places) 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as necessary 
to show the duration of the 
impact (see point 1.6) 

Total 

Specify  the  co-financing 
body  

TOTAL 
cofinanced  

appropriations 

37 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

37 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.3. 

Estimated impact on revenue  

–  (cid:59) Proposal/initiative has no financial impact on revenue. 

–  (cid:133) Proposal/initiative has the following financial impact: 

–  (cid:133) on own resources  

–  (cid:133) on miscellaneous revenue  

Appropriation
s available for 
the current 
financial year 

Budget revenue line: 

Article …………. 

EUR million (to three decimal places) 

Impact of the proposal/initiative38 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as necessary to show 
the duration of the impact (see point 1.6) 

For miscellaneous ‘assigned’ revenue, specify the budget expenditure line(s) affected. 

[…] 

Specify the method for calculating the impact on revenue. 

[…] 

38 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross after deduction of 25% for collection costs. 

EN 

38 

   EN 

 
 
 
 
 
 
 
 
 
 
                                                 
ANNEX: DETAILS OF CALCULATIONS 

General remarks 

It is proposed that the entire cost relating to pharmacovigilance  activities at the level of the 
Union  as  per  the  applicable  legislation  is  recouped  through  fees.  Cost  estimations  and 
calculations  in this  Annex are based on this principle and, therefore, the proposed measures 
are not expected to have any financial impact on the budget of the Union. 

The  cost  estimations  comprise  cost  of  the  Agency  activities  and  cost  of  rapporteurs' 
assessment  activities.  The  amounts  to  be  respectively  retained  by  the  Agency  and  paid  to 
rapporteurs where assessment has taken place are estimated accordingly. 

Amounts  that  are  proposed  for  remuneration  of  rapporteurs  are  based  on  the  estimated 
average  cost  of  assessment  work  in  the  context  of  the  pharmacovigilance  procedures  of  the 
Union. 

The costing table provides four general headings of cost: 

(1) 

(2) 

(3) 

(4) 

Periodic  Safety  Update  Reports  assessment  (procedural  cost,  both  for  the  Agency 
and rapporteurs of Member States) 

Post  Authorisation  Safety  Study  assessment  (procedural  cost,  both  for  the  Agency 
and rapporteurs of Member States) 

Pharmacovigilance  (Safety)  Referral  (procedural  cost,  both  for  the  Agency  and 
rapporteurs of Member States) 

Other cost: non-procedural cost, only incurred by the Agency. This heading includes 
ICT  systems  (e.g.  EudraVigilance  database,  repository  of  periodic  safety  update 
reports),  literature  monitoring,  ADR  ('adverse  drug  reaction':  reports  on  adverse 
effects of medicines) management and signal detection and risk management, within 
the scope of the Agency's responsibilities. 

Remuneration of rapporteurs of Member States is foreseen for work provided with respect to 
headings (1), (2) and (3), i.e. for the three Union-wide pharmacovigilance procedures. These 
three procedures will entail procedure-based fees, calculated based on cost estimation of the 
Agency's and rapporteurs' activities. 

As  regards  the  EMA's  cost  in  heading  'Other',  it  is  proposed  to  recoup  this  cost  through  an 
annual  flat  fee  to  be  charged  to  marketing  authorisation  holders  for  authorised  products 
registered by the Agency based on the list referred to in Article 57(2) of Regulation EC No 
726/2004,  using  chargeable  units  as  defined  in  the  proposed  Regulation.  Cost  estimations 
under  this  heading  (4)  include  only  costs  of  the  Agency,  whereas  Member  States  may 
continue charging national fees to cover costs at national level. 

Periodic Safety Update Reports assessment 

The  estimated  number  of  periodic  safety  update  reports  assessment  procedures  expected  by 
the Agency is 600 per year. The total estimated cost related to these assessments is € 11,3 m 
per year (€ 3,4 m Agency cost and € 7,9 m rappor
teur remuneration). The average cost for the 
proposed procedure-related fee is € 19 500 per procedure 39. The average part of the cost on 
which the proposed rapporteur remuneration is based is € 13 100 per procedure. 

Post-Authorisation Safety Study assessment 

39 

Amounts  that  are  used  for  fee  levels  and  rapporteur  remuneration  have  been  rounded  to  the  nearest 
hundred euros. Administrative cost is included. 

EN 

39 

   EN 

 
                                                 
The estimated number of post-authorisation safety study assessments expected by the Agency 
is  35  per  year.  The  total  estimated  cost  related  to  these  assessments  is  € 1,5 m  per  year 
(€ 0,9 m  Agency  cost and  € 0,6 m rapporteur remuneration). The average cost on  which the 
proposed  procedure-related  fee  is  based  is  € 43   000  per  procedure.  The  average  part  of  the 
cost on which the proposed rapporteur remuneration is based is € 18 200 per procedure.  

Pharmacovigilance Referral assessment 

The estimated number of Pharmacovigilance Referral assessments expected by the Agency is 
40 per year. The total estimated cost related to these assessments is € 6,7 m per year (€ 4,9 m 
Agency cost and € 1,8 m rapporteur remuneration). The average cost on which the proposed 
procedure-related  fee  is  based  is  €  168  600  per  procedure.  The  average  part  of  the  cost  on 
which the proposed rapporteur remuneration is based is € 45 100 per procedure. 

Mechanism of charging the fee for procedures for periodic safety update reports, post-
authorisation safety studies and pharmacovigilance referrals 

For periodic safety update reports and pharmacovigilance referral procedures, the fee will be divided 
among marketing authorisation holders involved in the procedure by charging them proportionately to 
the  respective  number  of  marketing  authorisations  (chargeable  units)  held  by  each  marketing 
authorisation holder. For post-authorisation safety study procedures, the fee is proposed to be divided 
among  all  marketing  authorisation  holders  having  the  obligation  to  produce  the  study  by  charging 
equal parts to each marketing authorisation holder. Further division of the cost may take place between 
marketing authorisation holders which have taken part in the study. 

Furthermore, the amount charged to marketing authorisation holders that are small and medium-sized 
enterprises will be reduced to 60% and marketing authorisation holders that are micro-enterprises will 
not be charged any fee. 

Mechanism of remunerating rapporteurs  

Rapporteurs'  remuneration  is  included  in  the  calculation  of  the  fee  for  each  Union-wide 
pharmacovigilance  procedure.  Full  rapporteur  remuneration  is  based  on  estimated  average  cost  per 
procedure. The applicable rapporteur remuneration follows the same pattern as the actual fee revenue 
per procedure, i.e. a reduced fee revenue entails a proportionately reduced rapporteur remuneration. 

Other pharmacovigilance activities of the Agency 

This heading of estimated cost of the Agency is taken into account in the calculations of the 
annual flat fee charged to all marketing authorisation holders with respect to their marketing 
authorisations  (chargeable  units,  as  recorded  by  the  Agency  based  on  the  list  laid  down  in 
Article  57(2)  of  Regulation (EC)  No  726/2004).  Marketing  authorisations  of  centrally 
authorised products are not subject to this fee, as they are already charged an annual fee, in 
accordance  with  Council  Regulation  (EC)  No  297/95,  which  is  assumed  to  cover  non-
procedure related pharmacovigilance activities for those products. 

The  total  estimated  cost  for  the  Agency  under  this  heading  is  € 19,1 m.  Calculations  in  the 
impact assessment based on this figure led to a proposed amount for the full flat fee of € 60 
per  marketing  authorisation,  that  should  be  counted  in  a  consistent  way  for  all  marketing 
authorisation  holders  based  on  chargeable  units.  It  is  proposed  that  marketing  authorisation 
holders that are small and medium-sized enterprises pay 60% of the full fee and that micro-
enterprises be exempted from the payment of the annual flat fee. Furthermore, a fee reduction 
of 20% is proposed for marketing authorisation holders for medicinal products referred to in 
Article  10(1)  and  Article  10a  of  Directive  2001/83/EC,  as  well  as  for  authorised  herbal 
medicinal products and authorised homeopathic medicinal products.  

EN 

40 

   EN 

 
Summary table of overall cost estimations 

Workload and cost estimation tables 

Activities 

EMA 

Rapporteurs / NCA 

Total 

Union-wide pharmacovigilance procedures 

PSUR assessment 

€3 435 671 

€7 857 374 

€11 293 045 

PASS assessment 

€866 456 

€636 778 

€1 503 234 

Pharmacovigilance 
referrals assessment 

€4 887 616 

€1 803 405 

€6 691 021 

Subtotal procedures 

€9 189 743 

€10 297 557 

€19 487 300 

Other pharmacovigilance activities of the EMA 

Other 

€18 825 914 

€232 606 

€19 058 520 

Grand total 

€28 015 657 

€10 530 163 

€38 545 820 

1. Periodic safety update reports assessment 

Activities 

s
r
u
o
h
f
o
r
N

d
e
r
i
u
q
e
r

/
e
t
a
r
y
l
r
u
o
H

e
g
a
w

EMA 

r
e
p
y
c
n
e
u
q
e
r
F

r
a
e
y

Rapporteurs / NCA 

EMA total 

s
r
u
o
h
f
o

.

o
N

d
e
r
i
u
q
e
r

/
e
t
a
r
y
l
r
u
o
H

e
g
a
w

r
e
p
y
c
n
e
u
q
e
r
F

  Rapporteur 

r
a
e
y

total 

Total cost 

t
n
e
m

s
s
e
s
s
a
R
U
S
P

1 

2 

3 

4 

5 

6 

6
a 

Preparation of list of 
harmonised submission 
dates for selected active 
substances 
Preparation of PRAC 
advice and updated 
EURD list following 
request for changes 
from MAH 
Validation of PSUR, 
preparation of data for 
Rapporteur from 
Eudravigilance database 
and other sources 

Preparation of PRAC, 
CHMP/CMDh outcome 

PRAC Staff time related 
to PSUR 

CHMP/CMDh Staff time 
related to PSUR 

Evaluation/assessment 
of PSUR applications 

 Subtotal PSUR 

   Average per procedure 

53,75 

124,1 

2 

€13 341 

21,5 

124,1 

10 

€26 682 

11,9 

124,1 

600 

€886 074 

5,1 

79,5 

600 

€243 270 

21,2 

124,1 

9,1 

79,5 

600 

600 

€1 578 552 

€434 070 

81 

81 

27 

124,1 

79,5 

124,1 

40,5 

79,5 

11 

11 

11 

11 

€110 573 

194 

109 

11 

€232 606 

€70 835 

€36 858 

32 

109 

11 

€38 368 

€35 417 

€3 435 671 

€5 726 

116 

109 

60
0 

€7 586 400 

€7 857 374 

€11 293 045 

€13 096 

€18 822 

EN 

41 

   EN 

 
 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
2. Post-authorisation safety study assessment 

Activities 

EMA 

Rapporteurs / NCA 

  Rapporteur 

r
a
e
y

total 

Total cost 

s
r
u
o
h
f
o
r
N

d
e
r
i
u
q
e
r

/
e
t
a
r
y
l
r
u
o
H

e
g
a
w

r
e
p
y
c
n
e
u
q
e
r
F

r
a
e
y

  EMA 
total 

s
r
u
o
h
f
o

.

o
N

d
e
r
i
u
q
e
r

/
e
t
a
r
y
l
r
u
o
H

e
g
a
w

r
e
p
y
c
n
e
u
q
e
r
F

25 

124,1 

35 

€108 588 

42,5  124,1 

35 

€184 599 

27,5  124,1 

35 

€119 446 

60 

124,1 

35 

€260 610 

54 

54 

27 

124,1 

79,5 

124,1 

40,5 

79,5 

11 

11 

11 

11 

€73 715 

130  109 

11 

€155 870 

€47 223 

€36 858 

32 

109 

11 

€38 368 

€35 417 

€866 456 

€24 756 

116  109 

35 

€442 540 

€636 778 

€1 503 234 

€18 194 

€42 950 

t
n
e
m

s
s
e
s
s
a
S
S
A
P

7 

8 

9 

10 

11 

12 

  12a 

l

o
c
o
t
o
r
P
S
S
A
P

Preparation of request 
including scientific 
questions and pre-
submission meeting 
Summary outcome of 
protocol and outcome 
documents for PRAC 
Summary outcome of 
protocol amendments 
and outcome 
documents for PRAC 
Summary of study 
report and outcome of 
report documents for 
PRAC and 
CHMP/CMDh 

PRAC Staff time 
related to PASS 

CHMP/CMDh Staff 
time related to PASS 

Evaluation/assessment 
of PASS applications 

Sub-total PASS 

Average per 
procedure 

EN 

42 

   EN 

 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
3. Pharmacovigilance referral assessment 

Activities 

EMA 

Rapporteurs / NCA 

  Rapporteur 

r
a
e
y

total 

Total cost 

s
r
u
o
h
f
o
r
N

d
e
r
i
u
q
e
r

/
e
t
a
r
y
l
r
u
o
H

e
g
a
w

r
e
p
y
c
n
e
u
q
e
r
F

r
a
e
y

EMA total 

s
r
u
o
h
f
o

.

o
N

d
e
r
i
u
q
e
r

/
e
t
a
r
y
l
r
u
o
H

e
g
a
w

r
e
p
y
c
n
e
u
q
e
r
F

73,8 

124,1 

40 

€366 343 

73,8 

79,5 

40 

€234 684 

300 

124,1 

40 

€1 489 200 

300 

79,5 

40 

€954 000 

193,75  124,1 

40 

€961 775 

193,75 

79,5 

40 

€616 125 

54 

54 

54 

81 

124,1 

79,5 

124,1 

79,5 

11 

11 

11 

11 

€73 715 

130  109 

11 

€155 870 

€47 223 

€73 715 

65 

109 

11 

€77 935 

€70 835 

l

a
r
e
f
f
e
R
e
c
n
a

l
i

g
i
v
o
c
a
m
r
a
h
P

n
o
i
t
a
i
t
i
n

I

t
n
e
m

s
s
e
s
s
A

t
n
e
m

s
s
e
s
s
a
-

t
s
o
p

 Preparation of 
procedure including 
scope of procedure, 
identification of 
products involved, List 
of Questions, analyses 
of in-house data 
Preparation of 
outcome documents 
for PRAC and 
CHMP/CMDh 
(temporary measures, 
list of outstanding 
issues, 
recommendations, 
opinions), analyses of 
in-house data, 
organisation of oral 
explanations, scientific 
advisory 
groups/expert 
meetings and public 
hearings 
Preparation and 
publication of 
information on 
webportal, 
communication, 
translations, access to 
document requests 
and re-examinations 
of applicable 

PRAC Staff time 
related to referrals 

CHMP/CMDh Staff 
time related to 
referrals 

13 

14 

15 

16 

17 

  17a 

Evaluation/assessment 
within PhV Refferals 

Sub-total PhV 
Referrals 

360  109 

40 

€1 569 600 

€4 887 616 

€1 803 405 

€6 691 021 

EN 

43 

   EN 

 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
4. Other costs of the Agency related to pharmacovigilance 

Activities 

EMA 

/
e
t
a
r
y
l
r
u
o
H

e
g
a
w

r
e
p
y
c
n
e
u
q
e
r
F

s
r
u
o
h
f
o
r
N

d
e
r
i
u
q
e
r

Rapporteurs / NCA 

r
a
e
y

EMA total 

s
r
u
o
h
f
o

.

o
N

d
e
r
i
u
q
e
r

/
e
t
a
r
y
l
r
u
o
H

e
g
a
w

r
e
p
y
c
n
e
u
q
e
r
F

  Rapporteur 

r
a
e
y

total 

Total cost 

18 

19 

22 

23 

24 

25 

26 

g
n
i
r
o
t
i
n
o
m
e
r
u
t
a
r
e
t
i
L

ICT 

t
n
e
m
e
g
a
n
a
m
k
s
i
R
+
g
n

i
l

d
n
a
h
s
R
D
A
+
n
o
i
t
c
e
t
e
d

l

a
n
g
S

i

Outsourced literature 
monitoring and 
entering of data in 
EudraVigilance 
Quality control of the 
outsourced activities 
and entered data 

  IT development and 
software maintanace 

  IT infrastructure 
maintanace  
Scientific validation of 
product and substance 
data submitted by the 
MAHs (outsorced) 
Clinical validation of 
signals, signal 
management by 
scientific staff and 
provision of analysis 
from EudraVigilance 
database and other 
data sources at the 
request from MS  
Management of RMPs 
including procedural 
support through PRAC, 
monitoring the 
outcome of risk 
minimisation measures 
and preparation of 
documents for 
publication for CAPs 
and for NAPs at the 
request of a member 
state. 
Monitoring the 
effectiveness of public 
health measures (e.g. 
risk management 
systems, through 
outsources studies of 
their outcomes using 
longitudinal patient 
databases). 
Coordination of 
pharmacovigilance 
inspections, 
information gathering 
on non-compliance and 
follow-up 

r
e
h
t
O

8153 

124,1 

1 

€1 011 787 

4455 

124,1 

1 

€552 866 

€4 882 643 

€2 061 636 

22390 

124,1 

1 

€2 778 599 

10 197  

124,1 

1 

 € 1 265 455 

2 499  

79,5 

1 

 €198 670  

17820 

124,1 

1 

€2 211 462 

6534 

79,5 

1 

€519 453 

7643 

124,1 

1 

€948 496 

6534 

124,1 

1 

€810 869 

3861 

79,5 

1 

€306 950 

EN 

44 

   EN 

 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
  
  
  
  
  
 
 
  
 
  
  
  
  
  
  
  
  
 
 
  
 
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
 
 
  
  
  
  
  
 
 
  
  
  
  
  
 
 
  
  
  
  
  
 
 
  
  
  
  
  
 
 
  
  
  
  
  
 
 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
27 

28 

29 

30 

Translations of 
communication related 
material and of data 
received from the 
public in relation to 
referrals 

PRAC Staff time 
(remaining) 

   PRAC meeting costs 

   CHMP meeting costs 

Sub-total other 

3370 

124,1 

1 

€418 217 

891 

891 

124,1 

79,5 

1 

1 

€110 573 

€70 835 

€564 503 

194 

10
9 

11 

€232 606* 

€112 901 

€18 825 914 

€232 606 

€19 058 520 

*reimbursement to PRAC members 

EN 

45 

   EN 

 
 
 
  
  
  
  
  
 
 
 
 
  
  
  
  
  
 
 
 
 
  
  
  
  
  
 
 
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Estimation of the overall impact of the proposed legislation on the budget of the Agency 

Year 2014* 

Year 2015 

Year 2016 

Year 2017 

Year 2018 

Year 2019 

Year 2020 

0 

€0 

38 

38 

38 

38 

38 

38 

€5 108 855 

€5 108 855 

€5 108 855 

€5 108 855 

€5 108 855 

€5 108 855 

€11 277 314 

€22 906 802 

€22 906 802 

€22 906 802 

€22 906 802 

€22 906 802 

€22 906 802 

€5 265 082 

€10 530 163 

€10 530 163 

€10 530 163 

€10 530 163 

€10.530.163 

€10 530 163 

FTE ** 

Annual 
salaries** 

Annual cost 
other than 
personnel 

Rapporteurs' 
remuneration 

Total cost 

€16 542 396 

€38 545 820 

€38 545 820 

€38 545 820 

€38 545 820 

€38.545.820 

€38 545 820 

Income PhV 
Fees 

€16 542 396 

€38 545 820 

€38 545 820 

€38 545 820 

€38 545 820 

€38.545.820 

€38 545 820 

Balance 

0 

0 

0 

0 

0 

0 

0 

*based on the assumption that the Regulation becomes applicable in summer 2014 

**incremental 
COM(2008) 664 final 

to  23  FTE  as  per 

The distribution by grades is as follows: 

financial  statement  of 

the  2008 

legislative  proposal,  

Posts 

AD12 

AD9 

AD8 

AD6 

Total AD 

AST3 

AST1 

Total AST 

Total posts 

2015 

2016 

2017 

2018 

2019 

2020 

1 

4 

9 

13 

27 

7 

4 

11 

38 

1 

4 

9 

13 

27 

7 

4 

11 

38 

1 

4 

9 

13 

27 

7 

4 

11 

38 

1 

4 

9 

13 

27 

7 

4 

11 

38 

1 

4 

9 

13 

27 

7 

4 

11 

38 

1 

4 

9 

13 

27 

7 

4 

11 

38 

The human resources required could be met by staff redeployed within the Agency or additional staff 
under the strict condition that sufficient posts are available within the context of the global legislative 
financial statements’ revision exercise and the annual allocation procedure for agencies, in the light of 
budgetary constraints which are applicable to all EU bodies. 

EN 

46 

   EN 

 
  
Agency data used for calculations of cost 

1. Productive working days/year 

2. Standard working hours/year 
Standard working hours/day 
x number of productive days/year 
Total number of productive hours/year 
3. Average staff cost 
Average salary items AD  
Overhead (non-salary cost, building, equipment, support and 
management) 
Total staff cost AD 
Average salary items AST  
Overhead (non-salary cost, building, equipment, support and 
management) 
Total staff cost AST 
Average salary items Contract Agent 
Overhead (non-salary cost, building, equipment, support and 
management) 
Total staff cost Contract Agent 

Notes: 
Weighting on salary items assumed (including exchange rate) 
Employers pension contribution included 

Source: EMA 
*A working week of 40 hours is applied to all calculations. 

2016 
199 
2016 
8 * 
199  
1 592  
2016 

2012 
198 
2012 
8 * 
198  
1 584  
2012 
138 579   142 655 
57 991 

51 638 

196 570   194 293 
77 250  
75 043  
44 456 
50 920 

125 963   121 706 
53 360  
48 538  
41 833 
47 970 

96 508  

95 193  

2012 
148 
no 

2016 
130 
yes 

EN 

47 

   EN