Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 726/2004 as regards information to the general public on medicinal products for human use subject to medical prescription and as regards pharmacovigilance
Date: 2011-10-11
Institutions: European Commission
Subjects: advertising, consumer information, drug surveillance, health control, market approval, marketing standard, medicinal product

EUROPEAN COMMISSION 

Brussels, 11.10.2011 
COM(2011) 632 final 

2008/0255 (COD) 

Amended proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EC) No 726/2004 as regards information to the general public on 
medicinal products for human use subject to medical prescription and as regards 
pharmacovigilance 

(Text with EEA relevance) 

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EXPLANATORY MEMORANDUM 

The Commission presents an amended proposal for a Regulation of the European Parliament 
and  of  the  Council  on  information  to  the  general  public  on  medicinal  products  subject  to 
medical prescription. Incorporated within the amended proposal are amendments proposed by 
the European Parliament at its first reading which are acceptable to the Commission.  

1. 

BACKGROUND 

On 10 December 2008, the Commission adopted a proposal for a Regulation of the European 
Parliament  and  of  the  Council  on  information  to  the  general  public  on  medicinal  products 
subject to medical prescription. This proposal was forwarded to the European Parliament and 
the Council on 10 December 2008.  

The Economic and Social Committee gave its opinion on 10 June 2009 and the Committee of 
the Regions, 7 October 2009.  

The European Parliament adopted a legislative resolution at its first reading on 24 November 
2010. 

2. 

OBJECTIVE OF THE COMMISSION'S PROPOSAL  

The general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation 
(EC) No 726/2004 are in line with the overall objectives of the EU pharmaceutical legislation. 
These  are  intended  to  ensure  the  proper  functioning  of  the  internal  market  for  medicinal 
products  for  human  use  and  to  better  protect  health  of  EU  citizens.  Following  this  line,  the 
proposals aim specifically to: 

•  Provide  for  a  clear  framework  for  provision  of  information  by  marketing  authorisation 
holders  about  their  prescription-only  medicines  to  the  general  public  with  a  view  to 
enhancing  the  rational  use  of  these  medicines,  while  ensuring  that  the  legislative 
framework  continues  to  prohibit  direct-to-consumer  advertising  of  prescription-only 
medicines. 

This aim shall be achieved by: 

•  Ensuring  the  high  quality  of  information  provided  by  coherent  application  of  clearly 

defined standards across the EU. 

•  Allowing information to be provided through channels addressing needs and capabilities of 

different types of patients. 

•  Allowing  marketing  authorization  holders  to  provide  in  an  understandable  way  objective 

and non-promotional information about the benefits and the risks of their medicines. 

•  Ensuring that monitoring and enforcement measures are in place to ensure that information 

providers comply with the quality criteria, while avoiding unnecessary bureaucracy. 

This  amended  proposal  is  in  line  with  those  objectives  and  further  reinforces  the  rights  of 
patients.  In  particular,  the  marketing  authorisation  holders  will  have  the  obligation,  and  no 

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longer  the  possibility,  to  make  available  certain  information,  such  as  the  labelling  and  the 
package leaflet. 

3. 

COMMISSION  OPINION  ON  THE  AMENDMENTS  ADOPTED  BY  THE  EUROPEAN 
PARLIAMENT: 

On 24 November 2010, the European Parliament adopted 12 amendments on the proposal for 
a  Regulation  on  information  to  the  general  public  on  medicinal  products  subject  to  medical 
prescription.  The  Commission  considers  that  a  majority  of  the  European  Parliament's 
amendments are acceptable in full, in principle, or in art, as they maintain the aims and overall 
scheme of the proposal. 

The  Commission  therefore  accepts  in  full  or  in  part,  the  following  amendments  of  the 
European Parliament: 

Recital  1  is  modified  in  accordance  with  amendment  1,  which  underlines  that  in  the 
Commission  Communication  transmitted  on  20  December  2007  concerning  the  "Report  on 
current  practices  with  regard  to  the  provision  of  information  to  patients  on  medicinal 
products"  the  need  for  a  more  precise  distinction  between  advertising  and  information  was 
highlighted.  

Amendment 2 specifies in recital 2 that the new Title introduced in Directive 2001/83/EC is 
intended to place emphasis on the rights and interests of patients. 

In  accordance  with  Amendment  6,  it  has  been  specified  in  Article  20b,  paragraph  1,  that 
although  the  pre-control  of  information  is  performed  by  the  Agency  for  centrally  approved 
medicinal  products,  the  monitoring  of  the  information  rests  with  Member  States.  It  is 
appropriate  to  ensure  consistently  that  the  Agency  is  also  responsible  for  the  control  of  the 
information  made  available  through  Internet  websites  registered  in  the  Member  States. 
Specific provisions are introduced to clarify the operation of this control mechanism in such 
case  of  information  made  available  through  Internet  websites  registered  with  the  Member 
States.  The  Commission  acknowledges  that  a  number  of  Member  States  have  expressed 
concerns  in  relation  to  the  conformity  with  their  national  constitutions.  The  Commission  is 
prepared to enter into a dialogue with those concerned  to find  suitable solutions while fully 
respecting the objectives of this Regulation. 

Following  Amendment  7,  the  word  "disseminated"  has  been  replaced  by  "made  available" 
within Article 20b, paragraph 2.  

Amendment  9  provides  for  the  procedure  regarding  cases  when  the  Agency  requests  for 
changes within the information submitted for control and for the fees applicable which should 
be  proportionate  to  the  additional  work.  Considering  that  the  normal  delay  is  60  days,  the 
subsequent delay should be of 30 days.  

Amendment  10  modifies  Article  57,  paragraph  1,  concerning  the  so-called  EudraPharm 
database and provides that it should be available in all EU languages. Such a change has been 
introduced as regards the lay-out of the database; on the other hand, the information contained 
in  the  database  will  be  available  in  the  languages  of  Member  States  where  the  medicinal 
product  is  authorised.  In  another  respect,  it  is  not  necessary  to  further  specify  that  the 
information  provided  is  designed  for  non-experts,  as  it  is  already  provided  that  it  should  be 
worded in an appropriate and comprehensible manner in accordance with article 57.  

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Amendment 12 provides that EudraPharm should be actively promoted to European citizens. 
This  should  be  done  through  the  development  of  the  European  medicines  web-portal 
established  by  Regulation  (EU)  No  1235/2010  as  the  central  point  of  access  to  information 
about medicinal products. On the other hand, it is not appropriate that information available 
on marketing authorisation holder websites is reproduced on EudraPharm, which is a public 
database.  

Pharmacovigilance 

In  addition  to  the  changes  introduced  on  the  basis  of  the  European  Parliament  resolutions 
regarding  the  Commission  proposals  on  information  to  patients,  the  Commission  considers 
that  limited  changes  to  Regulation  726/2004  in  the  area  of  pharmacovigilance  should  be 
introduced.  

Regulation (EC) No 726/2004 has been recently amended by Regulation (EU) No 1235/2010 
to revise the EU pharmacovigilance system. Regulation (EU) No 1235/2010 having as legal 
basis  Article  168(4)(c)  of  TFUE;  the  amended  proposal  should  also  be  based  on  Article 
168(4)(c)  of  TFUE.  Regulation  (EU)  No  1235/2010  substantially  strengthens  the  legal 
framework for the surveillance of medicinal products in the EU. However, in view of recent 
pharmacovigilance  events  in  the  EU,  the  Commission  has  detected  certain  areas  where  the 
legislation could be further strengthened. Therefore: 

– 

– 

– 

The new public list of medicinal products subject to additional monitoring introduced 
by Regulation (EU) No 1235/2010 will not necessarily include all medicinal products 
subject  to  post-authorisation  safety  conditions;  competent  authorities  will  have  to 
decide  on  a  case-by-case  basis  whether  to  make  public  the  fact  that  products  are 
subject  to  strengthened  surveillance.  For  the  sake  of  fuller  transparency  as  regards 
products under special surveillance, Article 23 should be modified to systematically 
include  medicinal  products  that  are  subject  to  conditions  and  requirements  with 
regard to safety. 

Article 13 is modified and a new Article 14b is introduced to avoid that the voluntary 
withdrawal of a marketing authorisation or product by the holder could lead to safety 
issues  not  being  addressed  in  the  EU,  by  clarifying  information  obligations  of  the 
marketing authorisation holder. 

Article 20 is modified to clarify the respective scopes of this provision and the EU 
procedures foreseen in Directive 2001/83/EC. 

4. 

CONCLUSION 

Having  regard  to  Article  293  of  the  Treaty  on  the  functioning  of  the  European  Union,  the 
Commission modifies its proposal as follows: 

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2008/0255 (COD) 

Amended proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EC) No 726/2004 as regards information to the general public on 
medicinal products for human use subject to medical prescription and as regards 
pharmacovigilanceamending, as regards information to the general public on medicinal 
products for human use subject to medical prescription, Regulation (EC) No 726/2004 
laying down Community procedures for the authorisation and supervision of medicinal 
products for human and veterinary use and establishing a European Medicines Agency 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European on the Functioning of the European 
Union Community, and in particular Article 95 114 and Article 168(4)(c) thereof, 

Having regard to the proposal from the European Commission1,  

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the ordinary legislative procedure laid down in Article 251 of the 
Treaty4, 

Whereas: 

(1) 

On 20 December 2007, the Commission submitted a Communication to the European 
Parliament and the Council concerning the "Report on current practices with regard to 
the provision of information to patients on medicinal products"5 . The report concludes 
that  Member  States  have  adopted  divergent  rules  and  practices  with  regard  to  the 
provision of information, resulting in a situation where patients and the public at large 
have unequal access to information on medicinal products. Experience gained from the 
application  of  the  current  legal  framework  has  also  shown  disparities  in  the 
interpretation  of  the  CommunityUnion  rules  on  advertising,  and  between  national 
provisions  on  information,  highlighting  the  need  for  a  more  precise  distinction 
between advertising and information. 

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OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
COM(2007) 862. 

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(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

The  introduction  of  a  new  Title  VIIIa  in  Directive  2001/83/EC  of  the  European 
Parliament and of the Council of 6 November 2001 on a Community code relating to 
medicinal  products  for  human  use6  addresses  those  concerns  through  various 
provisions  intended  to  ensure  the  availability  of  good-quality,  objective,  reliable  and 
non  promotional  information  on  medicinal  products  for  human  use  subject  to 
prescription and to place emphasis on the rights and interests of patients. 

Disparities  in  the  provision  of  information  on  medicinal  products  for  human  use  are 
not  justified  in  the  case  of  medicinal  products  authorised  pursuant  to  Title  II  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  Agency7  for  which  a  single  summary  of  the  products  characteristics  and 
package leaflet are approved for the whole CommunityUnion. Therefore Title VIIIa of 
Directive 2001/83/EC should also apply to those products.  

Directive  2001/83/EC  provides,  with  some  exceptions,  that  certain  types  of 
information  are  is  subject  to  control  by  the  Member  States'  national  competent 
authorities  prior  to  their  dissemination  being  made  available.  This  concerns 
information about non-interventional scientific studies, or accompanying measures to 
prevention  and  medical  treatment,  or  information  which  presents  the  medicinal 
product  in  the  context  of  the  condition  to  be  prevented  or  treated.In  the  case  of 
medicinal products for human use authorised pursuant to Title II of Regulation (EC) 
No 726/2004, provision should also be made for certain types of this information to be 
subject to prior vetting by the European Medicines Agency (hereinafter referred to as 
the 'Agency'), and to clarify the operation of the control mechanism in the case of 
information  made  available  through  Internet  websites  registered  with  the 
Member States in accordance with Directive 2001/83/EC.  

To  ensure  the  adequate  funding  of  these  activities  related  to  information,  provision 
should be made for the collection of fees charged to marketing authorisation holders 
by the Agency.  

In  order  to  ensure  transparency  on  the  surveillance  of  authorised  medicinal 
products,  the  list  of  medicinal  products  subject  to  additional  monitoring 
established by Regulation (EC) No 726/2004, as amended by Regulation (EU) No 
1235/2010 of the European Parliament and of the Council should systematically 
include  medicinal  products  that  are  subject  to  post-authorisation  safety 
conditions. 

Information on medicinal products is already provided at Union level by several 
databases  and  portals  managed  by  the  Agency  or  the  Commission  concerning 
inter alia medicinal products and clinical trials, such as the Orphanet portal for 
rare diseases and orphan drugs8. It is appropriate to link these different sources 
of  information  to  facilitate  access  by  the  public.  The  European  medicines  web 
portal created by Regulation (EC) No 726/2004, as amended by Regulation (EU) 

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OJ L 311, 28.11.2001, p. 87. 
OJ L 136, 30.4.2004, p. 1. 
COM(2008) 679 final 

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No  1235/2010  should  be  the  single  point  of  reference  for  access  to  that 
information. 

(8) 

As the prior vetting of information by the Agency will be financed by applicants' 
fees  which  are  to  be  adjusted,  it  is  appropriate  to  provide  for  a  deferred 
application of the provisions on the pre-vetting of information by the Agency.  

(69)  Since  the  objective  of  this  Regulation,  namely  to  provide  for  specific  rules  on 
information  on  medicinal  products  for  human  use  subject  to  prescription  authorised 
pursuant to Regulation (EC) No 726/2004 cannot be sufficiently achieved by Member 
States  and  can  be  better  achieved  at  CommunityUnion  level,  the  CommunityUnion 
may  adopt  measures,  in  accordance  with  the  principle  of  subsidiarity  as  set  out  in 
Article 5 of the Treaty. 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 this objective. 

(107)  Regulation (EC) No 726/2004 should therefore be amended accordingly, 

HAVE ADOPTED THIS REGULATION: 

Regulation (EC) No 726/2004 is amended as follows: 

Article 1 

(1) 

In Article 13(4), the second subparagraph is replaced by the following: 

"The  holder  shall  also  notify  the  Agency  if  the  product  ceases  to  be  placed  on  the 
market  of  the  Member  State,  either  temporarily  or  permanently.  Such  notification 
shall,  otherwise  than  in  exceptional  circumstances,  be  made  no  less  than  2  months 
before the interruption in the placing on the market of the product. The holder shall 
inform the Agency of the reasons for such action in accordance with Article 14b 
of this Regulation." 

(2) 

The following Article 14b is inserted: 

"Article 14b 

The  marketing  authorization  holder  shall  notify  the  Agency  forthwith  of  any 
action  taken  by  him  to  suspend  the  marketing  of  a  medicinal  product,  to 
withdraw a medicinal product from the market, to request the withdrawal of a 
marketing  authorisation  or  not  to  apply  for  the  renewal  of  a  marketing 
authorisation,  together  with  the  reasons  for  such  action.  The  marketing 
authorisation holder shall in particular declare if such action is linked to any of 
the  grounds  set  out  in  Articles  116  and  117  of  Directive  2001/83/EC.  In  such 
case, the Agency shall ensure that this information is brought to the attention of 
the Member States.  

(3) 

Article 20(8) is replaced by the following: 

‘8.  Where  the  procedure  results  from  the  evaluation  of  data  relating  to 
pharmacovigilance, the opinion of the Agency in accordance with paragraph 2 

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of  this  Article  shall  be  adopted  by  the  Committee  for  Medicinal  Products  for 
Human Use on the basis of a recommendation from the Pharmacovigilance Risk 
Assessment  Committee  and  Article  107j(2)  of  Directive  2001/83/EC  shall 
apply'.Notwithstanding paragraphs 1 to 7 of this Article, the Union procedures laid 
down  in  Article  31  and  Article  107i  of  Directive  2001/83/EC  shall  apply,  as 
appropriate, where the reason for the Member State or the Commission to consider 
taking decisions or measures referred to in this Article is based on the evaluation of 
data resulting from pharmacovigilance activities. 

(14) 

The following Articles 20a, and 20b and 20c are inserted:  

“Article 20a 

Title  VIIIa  of  Directive  2001/83/EC  shall  apply  to  medicinal  products  which 

1. 
are authorised under this Title and are subject to medical prescription. 

Article 20b 

1. 
By  way  of  derogation  from  Article  100g(1)  of  Directive  2001/83/EC, 
medicinal product-related information referred to in Article 100b(d) of that Directive 
concerning  medicinal  products  for  human  use  which  have  been  authorised  in 
accordance with this Regulation shall be subject to vetting by the Agency prior to 
its being made available dissemination.  

This shall be without prejudice to Article 100j of Directive 2001/83/EC relating 
to the monitoring by the Member States of the information made available.  

For  the  purposes  of  paragraph  1,  the  marketing  authorisation  holder  shall 
2. 
submit  to  the  Agency  a  mock-up  of  the  information  to  be  disseminatedmade 
available. 

The  Agency  may  object  to  the  information  submitted  or  parts  thereof  on 
3. 
grounds  related  to  non-compliance  with  the  provisions  of  Title  VIIIa  of  Directive 
2001/83/EC within 60 days after receipt of the notification. If the Agency does not 
object  within  60  days,  the  information  shall  be  deemed  accepted  and  may  be 
published. 

4. Where the marketing authorisation holder resubmits to the Agency a mock-
up of the information to be made available following objections by the Agency 
in application of paragraph 3, if the Agency does not object within 30 days, the 
revised information shall be deemed accepted and may be published. 

5.  The  Agency  may  if  appropriate  collaborate  with  Member  States  when  it 
performs the tasks set out in this Article.  

6. 
The submission of information to the Agency in accordance with paragraphs 1 
to 4, 2 and 3 shall be subject to a fee payable in accordance with Regulation (EC) No 
297/95.” 

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Article 20c 

1.  By  way  of  derogation  from  Article  100h(3)  of  Directive  2001/83/EC,  the 
Agency shall be responsible for the prior vetting in accordance with Article 20b 
of  this  Regulation  of  information  relating  to  medicinal  products  authorised  in 
accordance  with  this  Regulation  which  is  contained  in  Internet  websites 
registered  with  the  national  competent  authorities  of  the  Member  States  in 
accordance with Article 100h of Directive 2001/83/EC. 

2. Where a marketing authorisation holder intends to include information on a 
medicinal product authorised in accordance with this Regulation in an Internet 
website  registered  in  accordance  with  Article  100h  of  Directive  2001/83/EC,  it 
shall submit the information to the Agency for the application of Article 20b of 
this Regulation prior to it being made available, and inform the Agency of the 
Member State where the Internet website is intended to be or is registered. The 
Agency  shall  inform  the  concerned  Member  State  of  the  outcome  of  the 
procedure of Article 20b. 

3.  By  way  of  derogation  from  point  (c)  of  Article  100h(4)  of  Directive 
2001/83/EC,  if  a  Member  State  has  reasons  for  doubts  as  to  whether  the 
information  approved  in  accordance  with  Article  20b  of  this  Regulation  made 
available  on  a  registered  Internet  website  complies  with  the  requirements  of 
Title  VIIIa  of  Directive  2001/83/EC,  it  shall  inform  the  Agency  of  the  reasons 
for its doubts. The Member State concerned and the Agency shall use their best 
endeavours to reach agreement on the action to be taken. If they fail to reach an 
agreement within two months, the case shall be referred to the Pharmaceutical 
Committee  set  up  by  Council  Decision  75/320/EEC9.  Any  necessary  measures 
may  only  be  adopted  after  an  opinion  has  been  delivered  by  that  Committee. 
Member States and the Agency shall take account of opinions delivered by the 
Pharmaceutical Committee and shall inform the Committee of how its opinion 
has been taken into account. 

(5) 

Article 23 is replaced by the following: 

"Article 23 

1. The Agency shall, in collaboration with the Member States, set up, maintain and 
make public a list of medicinal products that are subject to additional monitoring. 

That list shall include the names and active substances of: 

(a)  medicinal  products  authorised  in  the Union  that  contain  a  new  active  substance 
which, on 1 January 2011, was not contained in any medicinal product authorised in 
the Union; 

(b)  any  biological  medicinal  product  not  covered  by  point  (a)  that  was  authorised 
after 1 January 2011;. 

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OJ L 147, 9.6.1975, p. 23.  

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(c)  2.  At  the  request  of  the  Commission,  following  consultation  with  the 
Pharmacovigilance  Risk  Assessment  Committee,  medicinal  products  that  are 
authorised pursuant to this Regulation subject to conditions referred to in points (c), 
(ca),  (cb)  and  (cc)  of  Article  9(4),  or  in  Articles  10a,  Article  14(7)  and  (8)  and  in 
Article 21(2), may also be included in the list.; 

(d) At the request of a national competent authority, following consultation with the 
Pharmacovigilance  Risk  Assessment  Committee,  medicinal  products  that  are 
authorised pursuant to Directive 2001/83/EC, subject to the conditions referred to in 
Articles 21a, 22, 22a and 104a of that Directive, may also be included in the list. 

3.2.  The  list  referred  to  in  paragraph  1  shall  include  an  electronic  link  to  the 
product information and to the summary of the risk management plan. 

43. In the cases referred to in points (a) and (b) of paragraph 1 of this Article, 
the  Agency  shall  remove  a  medicinal  product  from  the  list  5  five  years  after  the 
Union reference date referred to in Article 107c(5) of Directive 2001/83/EC. 

In  the  cases  referred  to  in  points  (c)  and  (d)  of  paragraph  1,  the  Agency  shall 
remove  a  medicinal  product  from  the  list  However,  the  Commission  or  the 
national  competent  authority,  as  appropriate,  may,  following  a  recommendation  of 
the  Pharmacovigilance  Risk  Assessment  Committee,  extend  that  period  once  until 
such time as they conclude that the conditions referred to in Article 14a and Article 
21(2)  of  this  Regulation  or  referred  to  in  Articles  22b  and  104a  of  Directive 
2001/83/EC have been fulfilled. 

5.4.  For  medicinal  products  included  in  that  list,  the  summary  of  product 
characteristics  and  the  package  leaflet  shall  include  the  statement  “This  medicinal 
product  is  subject  to  additional  monitoring”.  That  statement  shall  be  preceded  by  a 
black  symbol  which  shall  be  selected  by 
the  Commission  following  a 
recommendation  of  the  Pharmacovigilance  Risk  Assessment  Committee  by  2 
January  2012,  and  shall  be  followed  by  an  appropriate  standardised  explanatory 
sentence." 

(6) 

In Article 26 the following paragraph 3 is added: 

"3.  The  European  medicines  web-portal  shall  contain  at  least  links  to  the 
following: 

(a) the database on medicinal products referred to in point (l) of Article 57(1) of 
this Regulation, 

(b)  the  Eudravigilance  database  referred  to  in  Article  24(1)  and  point  (d)  of 
Article 57(1) of this Regulation, 

(c) the database referred to in Article 111(6) of Directive 2001/83/EC, 

(d) the Orphanet portal for rare diseases and orphan drugs, 

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(e)  the  Health  Portal  referred  to  in  Decision  1350/2007/EC  of  the  European 
Parliament and Council10." 

(7) 

In Article 57(1), point (l) is replaced by the following:  

"(l) creating a database on medicinal products, to be accessible to the general public 
and allowing searches in all official languages of the Union, and ensuring that it is 
updated, and managed independently of the commercial interests of pharmaceutical 
companies; the database shall facilitate the search for information already authorised 
for  package  leaflets;  it  shall  include  a  section  on  medicinal  products  authorised  for 
the treatment of children; the information provided to the public shall be worded in 
an appropriate and comprehensible manner.  

(28) 

In Article 57(1), the following point (u) is added: 

“(u) delivering opinions on reviewing information to the general public on medicinal 
products for human use subject to medical prescription.” 

(9) 

In Article 57(2), the first subparagraph is replaced by the following: 

"2.  The  database  provided  for  in  paragraph  1(l)  shall  include  the  summaries  of 
product characteristics, the patient or user package leaflet and the information shown 
on  the  labelling.  The  database  shall  be  developed  in  stages,  priority  being  given  to 
medicinal  products  authorised  under  this  Regulation  and  those  authorised  under 
Chapter  4  of  Title  III  of  Directive  2001/83/EC  and  of  Directive  2001/82/EC 
respectively. The database shall subsequently be extended to include any medicinal 
product  placed  on  the  market  within  the  EUnion.  That  database  shall  be  actively 
promoted to European Union citizens".  

Article 2 

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

2. It shall apply from [OJ: insert date of entry into force] with the exception of Article 1 
(4) and (8) which shall apply from [OJ: insert date of publication + 4 years]. 

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 

10 

OJ L301, 20.11.2007, p. 3.  

EN 

11 

   EN 

 
                                                 
LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1.  Title of the proposal/initiative: 

1.2.  Policy area(s) concerned in the ABM/ABB structure 

1.3.  Nature of the proposal/initiative  

1.4.  Objective(s)  

1.5.  Grounds for the proposal/initiative  

1.6.  Duration and financial impact  

1.7.  Management method(s) envisaged  

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

2.2.  Management and control system  

2.3.  Measures to prevent fraud and irregularities  

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

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

3.2.  Estimated impact on expenditure  

3.2.1. Summary of estimated impact on expenditure  

3.2.2. Estimated impact on operational appropriations  

3.2.3. Estimated impact on appropriations of an administrative nature 

3.2.4. Compatibility with the current multiannual financial framework 

3.2.5. Third-party participation in financing  

3.3.  Estimated impact on revenue 

EN 

12 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative 

Amended proposal for a  Directive of  the European Parliament and of the Council amending 
Directive  2001/83/EC,  as  regards  information  to  the  general  public  on  medical  products  for 
human use subject to medical prescription and as regards pharmacovigilance  

Amended proposal for a Regulation of the European Parliament and of the Council amending 
Regulation  (EC)  No  726/2004,  as  regards  information  to  the  general  public  on  medical 
products for human use subject to medical prescription and as regards pharmacovigilance  

This Legislative Financial Statement covers the two above-mentioned legal proposals 

1.2. 

Policy area(s) concerned in the ABM/ABB structure11  

Public Health 

1.3. 

Nature of the proposal/initiative  

x The proposal/initiative relates to a new action  

(cid:133) The proposal/initiative relates to a new action following a pilot project/preparatory action12  

(cid:133) 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  

Within  heading  1A,  Competitiveness  for  Growth  and  Employment,  the  proposal  aims  to 
promote public health across the EU through providing for harmonized rules on information 
on medicinal products subject to medical prescription 

Supporting the achievement of the internal market in the pharmaceutical sector. 

1.4.2. 

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

Specific objective No.. 

11 
12 

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

EN 

13 

   EN 

 
 
 
                                                 
Pre-control of the information for centrally authorised medicinal products. 

ABM/ABB activity(ies) concerned 

Public Health 

1.4.3.  Expected result(s) and impact 

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

The high level objective of the proposal is to improve the protection of health of  EU citizens and to 
ensure the proper functioning of the internal market for medicinal products for human use. Following 
this line, the proposal aims specifically to: 

Provide for a clear framework for provision on information by marketing authorisation holders about 
their  prescription-only  medicines  to  the  general  public  with  a  view  to  enhancing  the  rational  use  of 
these medicines, while ensuring that the legislative framework continues to prohibit direct-to-consumer 
advertising of prescription-only medicines. 

This aim shall be achieved by: 

- Ensuring the high quality of information provided by coherent application of clearly defined standards 
across the EU. 

- Allowing information to be provided through channels addressing needs and capabilities of different 
types of patients. 

-  Not  inappropriately  restricting  the  ability  of  marketing  authorization  holders  to  provide  in  an 
understandable way objective and non-promotional information about the benefits and the risks of their 
medicines. 

- Ensuring that monitoring and enforcement measures are in place to ensure that information providers 
comply with the quality criteria, while avoiding unnecessary bureaucracy. 

1.4.4. 

Indicators of results and impact  

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

The  Commission  has  established  mechanisms  for  working  with  the  Member  States  to  monitor 
transposition  and  in  the  pharmaceutical  sector  the  Commission's  Pharmaceutical  Committee  is  a  key 
forum for exchanging information in this regard.  

The  EMA  should  contribute  to  the  implementation,  although  no  scientific  assessment  of  information 
will be necessary. 

With regard to ex-post evaluation of the operational objectives, these can be evaluated by: 

- Extent of compliance with rules,  

- Information provision by industry, 

- Indicators of use of this information,  

- Patient awareness of this information,  

- Measuring the effect of information on patient behaviour and on health outcomes.  

EN 

14 

   EN 

 
1.5. 

Grounds for the proposal/initiative  

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

Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union. 

Patients  have  become  more  empowered  and  proactive  consumers  of  healthcare,  increasingly  seeking 
information  about  medicines  and  treatments.  While  Directive  2001/83/EC  provides  for  a  harmonised 
framework on advertising of medicines at EU level , the application of which remains a responsibility 
of  Member  States,  neither  Directive  2001/83/EC  nor  Regulation  (EC)  No  726/2004  include  detailed 
provisions on information on medicinal products. Therefore, EU legislation does not prevent Member 
States from establishing their own approaches. 

Divergent  interpretations  of  EU  rules  and  different  national  rules  and  practices  on  information  are 
creating  obstacles  to  patients'  access  to  high  quality  information  and  to  the  operation  of  the  internal 
market. 

1.5.2.  Added value of EU involvement 

Considering the existing harmonised EU legislation on the authorisation and supervision of medicinal 
products a common approach on information provision has to be taken. Harmonised provisions would 
allow  that  citizens  in  all  Member  States  have  access  to  the  same  type  of  information.  If  this  matter 
continues  to  be  left  for  national  rules,  it  will  almost  inevitably  lead  to  the  adoption  of  national  rules 
running counter to the spirit of the existing pharmaceutical legislation. 

National rules and practices on information may lead to restrictions to the free movement of goods in 
violation of Art 34 EU, impacting negatively on the completion of a single market in pharmaceuticals 
which the harmonised legal framework on medicinal products tries to achieve.  

1.5.3.  Lessons learned from similar experiences in the past 

N/A 

1.5.4.  Coherence and possible synergy with other relevant instruments 

N/A 

1.6. 

Duration and financial impact  

(cid:133) Proposal/initiative of limited duration  

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

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

X Proposal/initiative of unlimited duration 

–  Implementation with a start-up period from 2016 to 2021, 

EN 

15 

   EN 

 
 
–  followed by full-scale operation. 

1.7.  Management mode(s) envisaged13  

(cid:133) Centralised direct management by the Commission  

X Centralised indirect management with the delegation of implementation tasks to: 

–  (cid:133)  executive agencies  

–  X  bodies set up by the Communities14 : European Medicines Agency 

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

–  (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. 

Comments 

The EU system for regulating medicinal products operates as a network between the Commission, the 
European  Medicines  Agency  (EMA)  and  the  National  competent  authorities  for  medicinal  products. 
Responsibilities are frequently shared with the exact split depending on whether a medicine is centrally 
authorised  (with  the  Commission  as  competent  authority)  or  nationally  authorised  (with  the  Member 
States providing the competent authorities). 

Considering the existing harmonised EU legislation on the authorisation and supervision of medicinal 
products a common approach on information provision has to be taken. Harmonised provisions would 
allow  that  citizens  in  all  Member  States  have  access  to  the  same  type  of  information.  If  this  matter 
continues  to  be  left  for  national  rules,  it  will  almost  inevitably  lead  to  the  adoption  of  national  rules 
running counter to the spirit of the existing pharmaceutical legislation. 

National rules and practices on information may lead to restrictions to the free movement of goods in 
violation of Art 34 EU, impacting negatively on the completion of a single market in pharmaceuticals 
which the harmonised legal framework on medicinal products tries to achieve.  

13 

14 

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 

16 

   EN 

 
                                                 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

The  Commission  has  established  mechanisms  for  working  with  the  Member  States  to  monitor 
transposition  and  in  the  pharmaceutical  sector  the  Commission's  Pharmaceutical  Committee  is  a  key 
forum for exchanging information in this regard.  

EMA should contribute to the implementation, although no scientific assessment of information will be 
necessary.  

With regard to ex-post evaluation of the operational objectives, these can be evaluated by: 

- Extent of compliance with rules  
- Information provision by industry  
- Indicators of use of this information  
- Patient awareness of this information  
- Measuring the effect of information on patient behaviour and on health outcomes.  

2.2.  Management and control system  

2.2.1.  Risk(s) identified  

Main risk is the incorrect or incomplete transposition of EU legislation by the Member States. 

2.2.2.  Control method(s) envisaged  

The  Commission  has  established  the  Pharmaceutical  Committee  which  allows  for  the 
exchange of information between Member States and the Commission on the state-of play- of 
implementation of EU legislation 

2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

The  European  Medicines  Agency  has  specific  budgetary  control  mechanisms  and  procedures.  The 
Management Board, which comprises representatives of the Member States, the Commission and the 
European  Parliament,  adopts  the  budget,  as  well  as  the  internal  financial  provisions.  The  European 
Court of Auditors examines the execution of the budget each year.  

Regarding  fraud,  corruption  and  other  unlawful  activities,  the  provisions  of  Regulation  (EC)  No 
1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations 
conducted by the European Anti-Fraud Office (OLAF) apply to the EMA without restriction. Besides, a 
decision  concerning  co-operation  with 
the  OLAF  was  already  adopted  on  1  June  1999 
(EMEA/D/15007/99). 

Finally, the Quality Management System applied by the Agency supports a continuous review. Several 
internal audits are undertaken each year as part of this process. 

EN 

17 

   EN 

 
3. 

3.1. 

Heading of 
multiannual 
financial 
framework 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

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

•  Existing expenditure budget lines  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of  
expenditure

Contribution  

Number  
[Description………………………...……….] 

DA/NDA 
(15) 

from 
EFTA16 
countries 

from 
candidate 
countries17 

from third 
countries 

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

1A 

17.031001 
-  European  Medicines 
Agency — Subsidy under Titles 1 and 
2 

17.031002 
Agency — Subsidy under Title 3 

-  European  Medicines 

•  New budget lines requested  

DA 

YES 

NO 

NO 

NO 

DA 

YES 

NO 

NO 

NO 

Heading of 
multiannual 
financial 
framework 

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of 
expenditure

Contribution  

Number  
[Heading……………………………………..] 

Diff./non-
diff. 

[XX.YY.YY.YY] 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

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

YES/N
O 

YES/N
O 

YES/N
O 

YES/NO 

15 
16 
17 

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

EN 

18 

   EN 

 
 
 
 
 
                                                 
3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial 
framework:  

Number 

[.] 

EUR million (to 3 decimal places) 

DG: <> 

(cid:121) Operational appropriations  

Number of budget line – 17.031001 

Number of budget line – 17.031002 

Appropriations 
of 
 from the envelop of specific programs19  
Number of budget line 

an 

administrative 

TOTAL appropriations 
for DG <.> 

Year 
201618 

Year 
2017 

Year 
2018 

Year 
2019 

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

TOTAL 

Commitments 

Payments 

Commitments 

Payments 

(1) 

(2) 

(1a) 

(2a) 

nature 

financed 

Commitments 

Payments 

(3) 

=1+1a 
+3 

=2+2a 

+3 

18 
19 

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. 

19 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelop of specific programs  

(4) 

(5) 

(6) 

TOTAL appropriations  
under HEADING <1A.> 
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  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelop of specific programs  

(4) 

(5) 

(6) 

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

Commitments 

=4+ 6 

Payments 

=5+ 6 

EN 

20 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial 
framework:  

5 

" Administrative expenditure " 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

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

TOTAL 

EUR million (to 3 decimal places) 

DG: <…….> 

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

TOTAL DG <…….> 

Appropriations  

TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework  

(Total 
= Total payments) 

commitments 

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

Commitments 

Payments 

Year 
201620 

Year 
2017 

Year 
2018 

Year 
2019 

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

TOTAL 

EUR million (to 3 decimal places) 

20 

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

EN 

21 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.2.  Estimated impact on operational appropriations  

–  (cid:133)  The proposal/initiative does not require the use of operational appropriations  

–  x  The proposal/initiative requires the use of operational appropriations, as explained below:  

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

OUTPUTS 

Commitment appropriations in EUR million (to 3 decimal places) 

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

TOTAL 

r
e
b
m
u
N

s
t
u
p
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
u
o

f
o

Cost 

Total 
number 
of 
ouputs 

Total  
cost 

Indicate 
objectives 
and 
outputs  

Type of 
output21 

(cid:216) 

Aver
age 
cost  
of the 
ouput 

SPECIFIC OBJECTIVE No 122… 

- Output 

- Output 

- Output 

Sub-total for specific objective N°1 

SPECIFIC OBJECTIVE No 2… 

- Output 

Sub-total for specific objective N°2 

TOTAL COST 

21 
22 

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

EN 

22 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Impact on EMA budget 

The  Legislative  Financial  Statement  is  proposed  based  on  the  fact  that  the  legislative  proposal  foresees  that  specific  information  activities  of 
marketing authorization holders for centrally authorized medicinal products subject to medical prescription will be subject to fees charged by the 
European Medicines Agency (EMA).  

The Legislative Financial Statement and the calculations demonstrate that costs relating to activities resulting from the legislative proposal will be 
recuperated through fees. On this basis, the calculation leads to the conclusion that the proposals on information to the general public on medicinal 
products subject to medical prescription would not have a financial impact on the Union budget. 

The EMA budget is €208,9 million in 2011. The EU contribution ha s increased from €15,3 million in 2000 to € 38,4 million in 201 1. The remainder 
of  the  increase  of  the  budget  over  time  has  been  covered  by  fees  charged  by  the  EMA  to  the  pharmaceutical  industry  (estimated  at  85%  of  total 
income  in  2011  and  based  on  Council  Regulation  (EC)  No  297/95  as  amended  by  Commission  Regulation  No  312/2008  of  3  April  2008).  Fee 
revenues are anticipated to further increase in the coming years. It should be noted that based on fee income the EMA budget has run at a surplus in 
recent years and use has been made of the carry-over facility. Indeed, in 2010 the surplus was superior to €10 million. 

The legislative proposal foresees that the EMA shall be charged with the pre-control of the information for centrally authorised medicinal products. 

The  request  for  pre-control  shall  be  subject  to  a  fee  payable  in  accordance  with  Regulation  (EC)  No  297/95.  The  assessment  of  the  information 
submitted  shall  be  fully  conducted  by  EMA  staff.  Due  to  the  fact  that  EMA  activities  will  only  concern  pre-control  of  the  information  and  that 
subsequent  monitoring  will  be  undertaken  by  Member  States,  administrative  procedures  within  the  Agency  will  not  be  burdensome. However,  as 
some of the information will not have been already assessed by EMA in the context of the marketing authorisation process, for example information 
on the disposal and collection system of the product as well as information on prices which is under the exclusive competence of the Member States, 
this pre-control will demand coordination with the Member States and the impact of this work should be considered.  

Furthermore, applications might be submitted in other languages than EN, the usual working language of the Agency. Therefore either translations 
will need to be done or Staff Members will have to be able to work in several EU languages.  

The average cost of 1 full time equivalent (FTE) AD Staff Member for the EMA in London has been provided by the EMA (beginning 2011) as: 
Salary €161 708/year for AD and €90 091/year for AST, these ar

e the staff costs used for the calculations below.  

Fees charged by the EMA to the pharmaceutical industry 

Regarding EMA fees, the following estimates can be made: 

EN 

23 

EN 

 
  
At the moment 566 centrally authorised medicinal products exist. As per the EMA annual report 2009, there were 2577 variations, 708 out of them 
referred to type II clinical variations, which implied a substantial change in the product information. These procedures to change the initial marketing 
authorisation will also lead to new information on medicinal products to be pre-controlled. It can be estimated that during the first year of application 
of the proposed regulation approximately 700 submissions of information to be disseminated to the general public will be submitted to the Agency 
for  a  pre-control.  For  the  following  years,  an  increase  in  submissions  to  the  Agency  can  be  expected.  The  average  estimated  fee  charged  to  the 
pharmaceutical industry is € 3 650.  

Cost to the EMA 

As explained above, it can be estimated that 700 submissions about information to patients on centrally authorised products will need to be checked 
by the Agency in the first years (2016-2021). An increase of this number is to be expected to 800 submissions once pharmaceutical companies have 
got familiar with the new procedure (as from 2019).  

It can be estimated that total costs for EMA is made up by: 

1. the annual salary of the staff, comprising the following tasks: 

–  checking  the  information  on  the  basis  of  the  documentation  that  has  been  provided  by  the  pharmaceutical  company  and  on  the  basis  of  other 

scientific information, 

–  contacts with pharmaceutical companies if there is a need for extra information, 

–  contacts with Member States in order to have information which is under their competence and to ensure consistency, in particular with regard to 

information on clinical trials; 

–  internal discussions, 

–  administrative processing of the submission (incl. drafting of the conclusion) 

There  will  be  no  extra  costs  for  literature  screening  by  EMA,  because  the  information  to  patients  shall  be  based  on  the  documentation  that  the 
pharmaceutical companies provide in their application. 

2. translations: applications might be submitted in other languages than EN, the usual working language of the Agency. Therefore the application 
will have to be translated into EN in order to be checked by EMA and then its assessment will have to be translated back into the language of the 
applicant.  

EN 

24 

EN 

 
  
3. IT: the pharmaceutical industry will provide information through channels addressing needs and capabilities of different types of patients. This 
will include video, audio and written materials. In order to review, track and store this variety of communication media, the EMA will need to put in 
place appropriate infrastructure with compatible IT software. EMA foresees the development of the IT tool over 12 months for a total cost of €1,5 
million. Maintenance of the IT tool would cost €225 000 for the 1 st year of its functioning (n+1) and €300 000 per year for the following years. 

The total impact of the legislative proposal on EMA budget has been presented in the Tables below.  

Table: Impact on EMA budget – establishment plan23 

Year 2016 

Year 2017 

Year 2018 

Year 2019 

Year 2020  Year 2021 

FTE  for  core  activity  +  for 
management  overhead  (10%  of 
core activity) 

AD - €161 708/year  

AST - €90 091/year  

Contractual Agent 

SNE 

TOTAL staff 

4.4 

1.1 

0 

0 

5.5 

4.4 

1.1 

0 

0 

5.5 

4.4 

1.1 

0 

0 

5.5 

5.5 

1.1 

0 

0 

5.5 

2.2 

0 

0 

5.5 

2.2 

0 

0 

6.6 

6.6 

6.6 

Table: Impact on EMA budget – Statement of income and expenditure (€) 

EMA costs 

Year 2016 

Year 2017 

Year 2018 

Year 2019 

Year 2020  Year 2021 

Total annual staff costs (=Annual 
salary) 

810 615

810 615

810 615

988 494  1 087 594

1 087 594

23 

Assumption: there will be an increase in applications and no impact on EMA costs. 

EN 

25 

EN 

 
  
 
 
 
 
 
 
 
 
                                                 
Cost of translation into English24 

569 100

569 100

569 100

650 400 

650 400

650 400

Cost  of 
submission language24 

translation  back 

into 

569 100

569 100

569 100

650 400 

650 400

650 400

IT cost (development) 

1 125 000

375 000

IT cost (maintenance) 

225 000

300 000

300 000 

300 000

300 000

Total costs25 

Income fees26 

Balance  

3 073 815

2 548 815

2 248 815

2 589 294  2 688 394

2 688 394

2 555 000 

2 555 000

2 555 000

2 920 000  2 920 000

2 920 000

-518 815 

6 185

306 185

330 706 

231 606

231 606

The table shows that the EMA budget might run a negative balance in the first year (2016). This deficit would be covered by other income to the 
EMA budget.  

The calculation made in the table above is based on the model where EMA works in English, and therefore translates into EN applications submitted 
by  applicants  and  translates  into  the  original  language  the  EMA  pre-control  position  before  sending  it  to  the  applicant.  However  reality  may 
demonstrate that another model should be followed in order to ensure more efficiency in working directly in original languages, with the use of in-
house resources for the pre-control of the information and therefore not using translation. The staff allocation would have to be revised to a total of 
15 AD, with a concomitant reduction of translation costs.  

24 
25 
26 

For 7 pages 
An inflation rate of 2% should be taken into consideration. 
The fee for the pharmaceutical company will be €3 650 . 

EN 

26 

EN 

 
  
 
 
                                                 
3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary  

–  ⌧ The  proposal/initiative  does  not 

require 

the  use  of  administrative 

appropriations  

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

explained below: 

EUR million (to 3 decimal places) 

Year 
N 27 

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 administrative 
expenditure  

Subtotal HEADING 5 
of the multiannual 
financial framework  

Outside HEADING 528 
of the multiannual 
financial framework  

Human resources  

Other expenditure  
of an administrative 
nature 

Subtotal  
outside HEADING 5 
of the multiannual 
financial framework  

TOTAL 

27 
28 

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 

27 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.2.   Estimated requirements of human resources  

–  (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: 

Estimate to be expressed in full amounts (or at most to one decimal place) 

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) 

(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)29 

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 yy 30 

- at Headquarters31 

- in delegations  

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

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

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 agents 

External personnel 

29 

30 
31 

CA= Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune Expert en Délégation" (Young 
Experts in Delegations); LA= Local Agent; SNE= Seconded National Expert;  
Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
Essentially  for  Structural  Funds,  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and 
European Fisheries Fund (EFF). 

EN 

28 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.4.  Compatibility with the current multiannual financial framework  

–  X  Proposal/initiative  is  compatible  with  the  multiannual  financial  framework  starting 

2014. 

–  (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 framework32. 

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

3.2.5.  Third-party contributions  

–  The proposal/initiative does not provide for co-financing by third parties  

–  The proposal/initiative provides for the co-financing estimated below: 

Appropriations in EUR million (to 3 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 appropriations 
cofinanced  

32 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

29 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.3. 

Estimated impact on revenue  

–  X  Proposal/initiative has no financial impact on revenue. 

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

– 

– 

(cid:133) 

(cid:133) 

on own resources  

on miscellaneous revenue  

Appropriation
s available for 
the ongoing 
budget 
exercise 

Budget revenue line: 

Article …………. 

EUR million (to 3 decimal places) 

Impact of the proposal/initiative33 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

… insert as many columns as necessary 
in order to reflect 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. 

… 

33 

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

EN 

30 

   EN