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 medicinal products 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) 633 final 

2008/0256 (COD) 

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 
medicinal products 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  Directive  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  Directive  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 
the  quality  criteria,  while  avoiding 

information  providers  comply  with 
unnecessary bureaucracy. 

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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 longer just 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  78  amendments  on  the 
proposal for a Directive 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 part, 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: 

3.1. 

Amendments of a general nature 

Some of the amendments of the European Parliament, in particular 1, 4 13 and 70, 
provide  for  the  replacement  of  the  words  "disseminate"  by  "making  available"  the 
information.  These  changes  have  been  incorporated  within  the  whole  revised  text 
(recitals and articles) as foreseen by the amendments.  

Amendment  2  modifies  recital  2  in  order  to  stress  that  inequalities  in  accessing 
information  are  not  acceptable  and  should  be  adjust.  The  Commission  introduces 
these changes within recital 3.  

Amendment 3, that the amended proposal incorporates, modifies recital 4 calling for 
a  distinction  between  advertisement  and  information  in  order  that  all  citizens  have 
access to information in all Member States.  

Amendments 6 and 7 share the same aim which is to recognise that although some 
information  is  made  available  by  national  competent  authorities  and  healthcare 
professionals,  marketing  authorisation  holders  may  be  an  additional  source  of 
information. The Commission modifies accordingly recital 8. 

3.2. 

Scope of title VIII "Advertising" (Article 86(2)) 

Article  86(2)  of  Directive  2001/83/EC,  as  currently  in  force,  identifies  types  of 
information which are not covered by the Directive's title on advertising.  

Amendment 20 adds to the list in Article 86(2) correspondence needed to answer a 
specific question about a medicinal product, and amendment 21 adds some factual, 
informative announcements. The Commission agrees in principle; however, it is not 
necessary  to  specifically  mention  these  aspects  as  they  are  already  covered  by  the 
general indent on "information by the marketing authorisation holder to the general 
public  on  medicinal  products  subject  to  medical  prescription,  which  shall  comply 
with the provisions of Title VIIIa". 

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Amendments 22 and 23 clarify the elements listed in the Commission proposal as not 
covered by the advertisement title. In particular, amendment 23 adds, to the fact that 
information to the general public should comply with Title VIIIa, the requirement for 
such information to be approved by the authorities and to respect quality criteria. As 
these requirements are included in Title VIIIa, it is not necessary to repeat them. 

Amendment  24  adds  to  the  list  of  elements  which  should  not  be  covered  by  the 
advertisement title, factual, informative announcements for investors and employees 
on  significant  business  developments  provided  they  are  not  used  to  promote  the 
product  to  the  general  public.  This  amendment  is  incorporated  in  the  amended 
proposal; it is further specified that, however, if the information concerns individual 
medicinal  products,  the  conditions  of  Title  VIIIa  should  apply  to  ensure  that  the 
provisions of information to investors and employees is not used to circumvent the 
provisions of the Directive.  

Amendment  25  clarifies  that  in  cases  not  covered  by  the  advertising  title,  the 
marketing authorisation holder and any third party acting on behalf of the marketing 
authorisation  holder  making  available  the  information  should  be  identified  as  such. 
This has been introduced in Article 100a for all activities covered by the Directive's 
title on information. .  

3.3. 

Exception to advertising (Article 88(4)) 

Amendment 87 provides conditions that must be fulfilled by industry in order to be 
authorised to conduct advertising on vaccination campaigns.  

Directive 2001/83/EC provides that the prohibition of advertising does not apply to 
vaccination  campaigns  carried  out  by  industry  and  approved  by  the  competent 
authorities of the Member States. The original proposals extended this exception to 
public health campaigns in general. Amendment 87 deletes this proposed extension 
and imposes further requirements on possible vaccination campaigns. The amended 
proposal  incorporates  these  changes;  however  the  information  should  refer  only  to 
the vaccines and not to the diseases concerned as the scope of Directive 2001/83/EC 
is limited to medicinal products. 

3.4. 

Advertising to healthcare professionals (Article 94) 

Amendment  27  modifies  Article  94  which  regulates  the  advertising  to  healthcare 
professionals. It specifies that the rules should apply to direct or indirect promotion 
by marketing authorisation holder or a third party acting on its behalf or following its 
instructions.  The  Commission  supports  this  clarification,  which  should  not  be 
restricted  to  one  specific  article.  It  should  concern  all  Articles  on  advertising. 
Therefore the change is introduced in Article 86 at the beginning of the Title VIII on 
advertising.  

3.5. 

Scope  of  the  new  title  VIIIa  "Information  to  the  general  public  on  medicinal 
products subject to medical prescription" (Article 100a) 

Article  100a  defines  the  scope  of  the  title  of  the  Directive  on  information. 
Amendment 84, modifying Article 100b on the content of the information, makes the 
distinction  between  information  that  marketing  authorisation  holders  should  make 

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available  and  information  that  he  may  make  available.  By  creating  this  distinction, 
the  European  Parliament  re-orientates  the  text  from  the  right  of  marketing 
authorisation holders to make available some information to the right of the patients 
to  have  information.  This  re-orientation  should  also  be  reflected  in  Article  100a. 
Furthermore, requirements added by this amendment regarding identification of the 
marketing authorisation holder and control mechanisms do not have to be specified 
in this Article as they are provided for in specific articles.  

Amendment  29  provides  that  healthcare  professionals  who  deliver  information  on 
medicinal products during public events should declare their financial interests with 
marketing  authorisation  holders.  The  Commission  supports  this  amendment,  which 
can however only concern medicinal products and not medical devices in view of the 
scope  of  the  Directive.  This  amendment  is  covered  by  the  introduction  within  the 
amended proposal of the obligation for any person making available information to 
the  public  to  declare  any  financial  or  other  benefits  from  marketing  authorisation 
holders.  

Amendment 31 modifies the list of types of information which should not be covered 
by the Directive's title on information. The Commission supports this amendment to 
the  extent  that  it  is  consistent  with  Article  100b  on  the  content  of  information  that 
may be made available.  

Amendments  8  and  32  exclude  from  the  scope  of  the  Directive  information  made 
available  by  third  parties  acting  independently  from  the  marketing  authorisation 
holder  in  order  for  them  to  express  their  views  on  prescription-only  medicinal 
products.  The  Commission  supports  this  exclusion.  In  addition,  in  order  to  ensure 
transparency  about  information  provided  by  third  parties,  they  should  declare  their 
interests when making available information on medicinal products.  

3.6. 

Content of the information (Article 100b) 

Amendments  10  and  84  (modifying  Article  100b)  make  the  distinction  between 
information  that  marketing  authorisation  holders  should  make  available  and 
information that they may make available. Such a distinction was not included in the 
original  proposal,  where  no  mandatory  obligations  were  created.  The  Commission 
accepts these amendments.  

However,  regarding  the  list  of  information  that  can  be  made  available,  Directive 
2010/84/EU amending Directive 2001/83/EC as regards pharmacovigilance provides 
within Article 106a requirements applicable to public announcements by marketing 
authorisation  holders  relating  to  information  on  pharmacovigilance.  Therefore, 
information regarding adverse-reaction warnings should be excluded from the scope 
of the Directive's Title on information, as it is specifically addressed by the Title on 
pharmacovigilance.  

Lastly, requirements linked to channels of information, persons with disabilities and 
control (also contained in the amendment) do not have to be specified in this Article 
as they are provided for in specific Articles.  

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3.7. 

Channels of information (Article 100c) 

Amendments 12 and 34 delete the possibility to make available information through 
health-related  publications  and  provide  that  it  cannot  be  made  available  through 
newspapers,  magazines  and  similar  publications.  However,  the  amendments 
introduce  the  possibility  to  make  available  information  through  printed  materials 
about a medicinal product prepared by marketing authorisation holders upon specific 
request by a member of the general public. The Commission accepts these changes; 
however it is the issuing of these printed materials that should be on request, not their 
drafting.  

3.8. 

Quality criteria and statements (Article 100d) 

Amendments  35,  36  and  37  modify  some  of  the  quality  criteria  applicable  to  the 
information.  

Amendments 39, 40, 41, 42 and 43 modify the statements that must be available with 
the  information  and  add  two  others:  a  statement  containing  contact  information 
allowing  members  of  the  public  to  contact  competent  authorities,  and  a  statement 
containing a reference to the most recent package leaflet or an indication as to where 
that text can be found. These amendments have been included in Article 100d. The 
elements  of  amendment  41  which  relate  to  monitoring  are  not  included  in  the 
amended  Article  100d,  but  are  added  in  the  specific  Article  on  monitoring.  The 
elements  of  amendment  43  referring  to  internet  websites  are  included  in  Article 
100h.  

Amendment 44 requires a statement encouraging the report of undesirable effects to 
doctors,  pharmacists,  healthcare  professionals  and  competent  authorities.  Although 
the  Commission  supports  this  proposal,  it  considers  that  a  specific  statement  to 
encourage  this  reporting  of  undesirable  effects  is  not  necessary.  Indeed,  Directive 
2010/84/EU  already  introduces  such  a  statement  within  Article  59  of  Directive 
2001/83/EC on information to be included within the package leaflet.  

Paragraph  3  of  Article  100d  provides  the  elements  that  the  information  should  not 
include, such as comparisons between medicinal products. Amendment 46 adds the 
inducement  to  or  the  promotion  of  the  consumption  of  the  medicinal  product. 
Although  the  Commission  supports  this  principle,  the  text  does  not  need  to  be 
modified  to  reflect  this  aspect  as  this  follows  already  from  the  provisions  of  the 
Directive (Article 86). Indeed, all information that can be made available under Title 
VIIIa should not induce or promote the consumption of medicinal product.  

Amendment 48 aligns to the Treaty of Lisbon the granting to the Commission of the 
power to adopt measures necessary for the implementation of Article 100d. The acts 
adopted by the Commission should be implementing acts and not delegated acts, as 
they are limited to the implementation of the quality criteria which are laid down in 
the proposal.  

3.9. 

Language aspects (Article 100e) 

Amendments  49,  50  and  52  refer  to  Article  100e  on  languages;  however  the 
modifications  concern  other  aspects  and  therefore  have  been  introduced,  if  not 

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already provided for, in the corresponding Articles on quality criteria (Article 100d), 
monitoring  (Article  100g),  control  (Article  100j)  and  internet  websites  (Article 
100h).  

3.10. 

Persons with disabilities (Article 100f) 

Amendment 53 aligns with the Treaty of Lisbon the delegation to the Commission to 
amend the Article to take account of technical progress.  

3.11.  Control of the information (Article 100g) 

Amendments  9,  11,  56  and  96  provide  for  the  pre-control  of  the  information  by 
competent  authorities,  including  through  the  marketing  authorisation  process,  and 
delete  the  possibility  for  Member  States  to  opt  for  voluntary  control  by  self-
regulatory  or  co-regulatory  bodies.  A  derogation  from  the  system  of  pre-control  is 
foreseen  for  Member  States  which  have  implemented  other  type  of  control 
mechanisms before 31 December 2008.  

The  Commission  accepts  this  principle  of  pre-control  and  the  possibility  for 
derogations.  For  the  latter,  in  addition  to  the  derogation  for  pre-existing  systems 
foreseen by the amendments, an additional derogation should be included for cases 
where  Member  States  cannot  introduce  a  system  of  pre-control  for  constitutional 
reasons related to the principles of freedom of expression and of the press. However, 
the  Commission  should  not  be  tasked  to  verify  and  approve  alternative  national 
systems.  

As  the  possibility  to  opt  for  voluntary  control  by  self-regulatory  or  co-regulatory 
bodies are deleted in the new proposal, the provisions for a code of conduct adopted 
by the Commission has been deleted, while maintaining provisions for Commission 
guidelines.  

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  Directive.  As  regards  this 
Directive, apart from the control mechanism, as some of the provisions introduced by 
this Directive may interfere with national constitutional rules relating to freedom of 
the press and freedom of expression in the media, the Commission introduces recital 
16 clarifying that this Directive does not prevent Member States from applying these 
constitutional rules.  

3.12. 

Internet websites (Article 100h) 

Article  100h  lays  down  rules  for  marketing  authorisation  holders'  internet  websites 
making available information on medicinal products under prescription status.  

Amendment  58  clarifies  that  the  information  available  on  these  websites  shall 
comply with the requirements of the Directive and that it shall be in accordance with 
the  marketing  authorisation  of  the  medicinal  product.  Although  the  Commission 
agrees with this, it is not necessary to specify it, as this already follows from other 
provisions of the Directive. 

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Amendment  59  foresees  the  identification  of  the  marketing  authorisation  holder  in 
the websites. However this identification is already provided for within Article 100d, 
paragraph 2. 

Amendment  60  provides  that  any  update  of  the  information  is  subject  to  the 
monitoring without leading to a re-registration of the website. It should also be stated 
that  the  new  information  is  also  subject  to  the  requirement  of  control  provided  by 
Article 100g. 

Amendment  61  deals  with  the  possibility  of  including  video  content  on  internet 
websites.  The  modification  of  Article  100d(2)  by  amendment  84  (allowing  still  or 
moving  images  of  technical  nature  demonstrating  the  proper  way  of  using  the 
product) is sufficient in this regard.  

The Commission agrees to the linkage of marketing authorisation holder websites to 
EU  databases  and  portals  on  medicinal  products,  introduced  by  amendment  62. 
However,  it  is  more  appropriate  to  link  marketing  authorisation  holder  websites  to 
the EU medicines web-portal established by Regulation (EU) No 1235/2010 than to 
the  EudraPharm  database,  as  that  portal  is  intended  to  become  the  central  point  of 
access  to  information  on  medicines.  Furthermore,  the  identification  of  marketing 
authorisation  holders  providing  the  information  is  already  required  in  Article 
100d(2);  therefore  the  Commission  considers  that  a  reference  to  this  Article  is 
sufficient.  

3.13. 

Penalties (Article 100i) 

Article 100i on penalties is modified in order to provide for the possibility to publish 
the  name  of  marketing  authorisation  holders  who  have  published  information  on  a 
medicinal product which is non-compliant with the Directive (amendment 67), to lay 
down  the  right  of  appeal  of  marketing  authorisation  holders  and  to  introduce  the 
suspension  of  the  dissemination  of  the  information  while  the  proceedings  are  on-
going (amendment 69).  

3.14.  Monitoring of the information (Article 100j)  

Article  100j  refers  to  marketing  authorisation  holders'  obligations  to  allow  the 
monitoring of the information provided. Amendment 52, modifying Article 100e, to 
keep  replies  available  for  inspections  by  national  competent  authorities,  should 
therefore be introduced within Article 100j.  

3.15.  Consultation (Article 100ka) 

Amendments  16,  90,  92,  93  and  94  refer  to  the  consultation  of  all  relevant 
stakeholders  such  as  independent  patient,  health  and  consumer  organisations  on 
issues  relating  to  the  implementation  of  the  Directive  and  its  application  by  the 
Member  States.  The  consultation  of  appropriate  stakeholders  is  part  of  the  inter-
institutional agreement on better law making (2003/C321/01) and therefore it is not 
necessary to mention each time examples of these stakeholders, neither to provide for 
a stand-alone article on that matter.  

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3.16. 

Information provided by other sources than the marketing authorisation holder 
(Articles 21 and 106) 

Amendment 79 provides for information about diseases and health conditions and the 
prevention of such diseases and conditions. The Commission recognises the need for 
such  broader  information,  however,  this  cannot  be  addressed  within  the  Directive 
which covers medicinal products only.  

The  part  of  the  amendment  intended  to  task  Member  States  with  ensuring  that 
objective, unbiased information is available to general public or members thereof has 
been  introduced  in  Article  106.  This  Article  following  amendment  of  Directive 
2001/83/EC  by  Directive  2010/84/EU  already  provides  a  key  tool  to  fulfil  the 
objective of the amendment (the creation of medicines web portals in every Member 
States).  

3.17.  Comitology alignment (Article 100k) 

Amendments 15, 75 to 77 are intended to include in Directive 2001/83/EC, in view 
of the entry into force of the Treaty of Lisbon, general provisions on the granting of 
delegated powers to the Commission. However, these Articles have been introduced 
into the Directive by Directive 2010/84/EU. It is only necessary to adapt Article 121a 
on the exercise of the delegation to include the reference to Article 100f, paragraph 2 
which provides for delegated acts.  

3.18. 

Pharmacovigilance 

In  addition  to  the  changes  introduced  on  the  basis  of  the  European  Parliament 
resolution  regarding  the  Commission  proposal  on  information  to  patients,  the 
Commission  considers  that  certain  changes  to  Directive  2001/83/EC  in  the  area  of 
pharmacovigilance should be introduced.  

Directive 2001/83/EC has been recently amended by Directive 2010/84/EU to revise 
the  EU  pharmacovigilance  system.  Directive  2010/84/EU  having  as  legal  basis 
Article  168(4)(c)  of  TFUE;  the  amended  proposal  should  also  be  based  on  Article 
168(4)(c)  of  TFUE.  Directive  2010/84/EU  substantially  strengthens  the  legal 
framework  for  the  surveillance  of  medicinal  products  authorised  by  the  Member 
States,  with  provisions  to  reinforce  the  coordinating  role  of  the  Agency,  the 
possibilities  for  signal  detection,  and  the  operation  of  coordinated  procedures  at 
European  level  to  respond  to  safety  concerns.  However,  in  view  of  recent 
pharmacovigilance  events  in  the  EU,  the  Commission  has  detected  certain  areas 
where the legislation could be further strengthened. Therefore: 

•  Articles  107i  is  modified  in  order  to  provide  for  an  automatic  procedure  at 
European  level  in  the  cases  of  specific  serious  safety  issues  with  nationally 
authorised  products,  with  a  view  to  ensuring  that  the  matter  is  assessed  and 
addressed  in  all  Member  States  where  the  medicinal  product  is  authorised. 
Articles  31  and  34  are  also  modified  to  clarify  the  respective  scopes  of  this 
provision and the revised automatic procedure, as well as the links between these 
procedures and procedures involving medicinal products authorised in accordance 
with Regulation (EC) No 726/2004. 

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•  Articles  23a  and  123  are  modified  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 for the marketing 
authorisation holder. 

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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2008/0256 (COD) 

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 medicinal 
products subject to medical prescription and as regards pharmacovigilance amending, as 
regards information to the general public on medicinal products subject to medical 
prescription, Directive 2001/83/EC on the Community code relating to medicinal products for 
human use 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community  on  the  Functioning  of  the 
European Union, and in particular Article 95 114 and 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, 

Acting  in  accordance  with  the  ordinary  legislative  procedure  laid  down  in  Article  251  of  the 
Treaty3, 

Whereas: 

(1) 

(2) 

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  use4  establishes 
harmonised  rules  on  the  advertising  of  medicinal  products  for  human  use.  In  particular,  it 
prohibits  the  advertising  to  the  general  public  of  medicinal  products  subject  to  medical 
prescription.  

In the area of information, Directive 2001/83/EC lays down detailed rules on the documents 
to  be  annexed  to  the  marketing  authorisation  and  intended  for  information  purposes:  the 
summary of product characteristics (distributed to health-care professionals) and the package 
leaflet (inserted in the product's packaging when it is dispensed to the patient). On the other 
hand,  as  regards  the  dissemination  making  available  of  information  from  the  marketing 
authorisation  holder  to  the  general  public,  including  patients,  the  Directive  only  provides 
that  certain  information  activities  are  not  covered  by  the  rules  on  advertising,  without 
providing for a harmonised framework on the contents and the quality of non promotional 

1 
2 
3 
4 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ L 311, 28.11.2001, p. 87. 

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(3) 

(4) 

(5) 

(6) 

(7) 

information on medicinal products or on the channels through which this information may 
be disseminated made available. 

On the basis of Article 88a of Directive 2001/83/EC, on 20 December 2007 the Commission 
submitted  a  Communication  to  the  European  Parliament  and  the  Council  on  a  "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.  Such 
unjustifiable  inequalities  in  accessing  information  that  is  publicly  available  in  other 
Member States should be redressed. 

Experience gained from the application of the current legal framework has also shown that 
certain restrictions on the possibilities of pharmaceutical companies to provide information 
result from the fact that the distinction between the notions of advertising and information is 
not interpreted consistently across the Community Union, and that this has also given rise 
to situations where the general public is exposed to disguised advertising. As a result, 
citizens in certain Member States may be denied the right to have access, in their own 
language,  to  high-quality,  non-promotional  information  on  medicinal  products.  The 
distinction  between  advertising  and  information  should  be  clarified  in  order  to  be 
interpreted uniformly across all Member States so as to ensure patient safety.  

Those  disparities  in  the  interpretation  of  the  Community  Union  rules  on  advertising,  and 
between  national  provisions  on  information  have  a  negative  impact  on  the  uniform 
application  of  Union  Community  rules  on  advertising,  and  on  the  effectiveness  of  the 
provisions on product information contained in the summary of products characteristics and 
the package leaflet.  Although  those rules are fully harmonised to ensure the same  level of 
protection  of  public  health  across  the  Community  Union,  this  objective  is  undermined  if 
widely  divergent  national  rules  on  the  dissemination  making  available  of  such  key 
information are allowed. 

The different national measures are also likely to have an impact on the proper functioning 
of the internal market for medicinal products, as the possibility for marketing authorisation 
holders  to  disseminate make  available  information  on  medicinal  products  is  not  the  same 
across  Member  States,  while  information  disseminated  made  available  in  one  Member 
State is likely to have effects in other Member States. This impact will be greater in the case 
of  medicinal  products  whose  product  information  (summary  of  product  characteristics  and 
package leaflet) is harmonised at Community Union level. This includes medicinal products 
authorised by the Member States under the mutual recognition framework of Chapter IV of 
Title III of Directive 2001/83/EC. 

In  the  light  of  the  above  and  taking  into  account  technological  progress  with  regard  to 
modern communication tools and the fact that patients throughout the European Union have 
become  increasingly  active  as  regards  healthcare,  it  is  necessary  to  amend  the  existing 
legislation  in  order  to  reduce  differences  in  access  to  information  and  to  allow  for  the 
availability  of  good-quality,  objective,  reliable  and  non  promotional  information  on 
medicinal products by placing emphasis on the rights and interests of patients. Patients 
should have the right to easily access certain information such as the summary of the 
product characteristics, the package leaflet and the assessment report. 

5 

COM(2007) 862 final.  

EN 

12 

   EN 

 
                                                 
(8) 

(9) 

National  competent  authorities  and  health  care  professionals  should  remain  important  the 
main sources  of  information on medicinal products for the general public. While there is 
already  independent  information  on  medicinal  products,  for  example  by  national 
authorities  or  health  care  professionals,  the  situation  differs  very  much  between 
Member  States  and  among  medicinal  products.  Member  States  should  facilitate  the 
access  of  citizens  to  high-quality  information  through  appropriate  channels.  Marketing 
authorisation holders may be an additional valuable source of non promotional information 
on their medicinal products. This Directive should therefore establish a legal framework for 
the  dissemination  making  available  of  specific  information  on  medicinal  products  by 
marketing authorisation holders to the general public. The ban on advertising to the general 
public for prescription-only medicinal products should be maintained. 

Third parties, such as patients and patients' organisations or the press, should be able 
to  express  their  views  on  prescription-only  medicinal  products,  and  should  therefore 
not  be  covered  by  the  provisions  laid  down  in  this  Directive,  provided  that  they  are 
the  marketing  authorisation  holder.  To  ensure 
acting 
independently  from  marketing 
transparency  as  to  whether  third  parties  act 
authorisation holders, when making available information, third parties should declare 
any financial or other benefits received from marketing authorisation holders.  

independently 

from 

(910)  In accordance with the principle of proportionality, it is appropriate to limit the scope of this 
Directive to the making available of information on prescription-only medicinal products, 
as current Community Union rules allow the advertising to the general public of medicinal 
products not subject to prescription, under certain conditions.  

(1011) Provisions  should  be  established  to  ensure  that  only  high-quality  non-promotional 
information  about  the  benefits  and  the  risks  of  medicinal  products  subject  to  medical 
prescription may be disseminated made available. The information should take into account 
patients  needs  and  expectations  in  order  to  empower  patients,  allow  informed  choices  and 
enhance  the  rational  use  of  medicinal  products.  Therefore,  any  information  to  the  general 
public on prescription-only medicinal products should comply with a set of quality criteria. 

(1112) In  order  to  further  ensure  that  patients  have  access  to  marketing  authorisation  holders 
disseminate  only  high-quality  information  and  to  distinguish  non-promotional  information 
from advertising, the types of information which may be disseminated made available by 
marketing  authorisation  holders  should  be  defined.  Marketing  authorisation  holders 
should  be  obliged  to  make  available  the  approved  and  most  recent  contents  of 
summaries  of  the  product  characteristics,  labelling  and  package  leaflet  and  the 
publicly accessible version of the assessment report. It is appropriate to allow marketing 
authorisation  holders  to  disseminate  also  make  available  the  contents  of  the  approved 
summaries  of  product  characteristics  and  package  leaflet,  information  that  is  compatible 
with  those  documents  without  going  beyond  their  key  elements,  and  other  well-defined 
medicinal product-related information.  

(1213) Whether  obligatory  or  not,  Iinformation  to  the  general  public  on  prescription-only 
medicinal  products  should  only  be  provided  through  specific  channels  of  communication, 
including  Internet  and  health-related  publications,  to  avoid  that  the  effectiveness  of  the 
prohibition  on  advertising  is  undermined  by  unsolicited  provision  of  information  to  the 
public.  Where  information  is  disseminated  made  available  via  television,  or  radio  or 
printed  media,  patients  are  not  protected  against  such  unsolicited  information  and  such 
dissemination channels of information should therefore not be allowed. 

EN 

13 

   EN 

 
(1314) The Internet is of major importance with regard to the provision of information to patients 
and its importance is increasing. The Internet allows almost unlimited access to information 
disregarding national boundaries. Registered websites for objective and non-promotional 
information  are  therefore  necessary  and  Sspecific  rules  on  the  monitoring  of  those 
websites  should  be  established  to  take  account  of  the  cross-border  nature  of  information 
provided over the Internet and to allow cooperation between the Member States.  

(1415) Monitoring  of  information  on  prescription-only  medicinal  products  should  ensure  that 
marketing  authorisation  holders  only  disseminate  make  available  information  which  is  in 
compliance  with  Directive  2001/83/EC.  Member  States  should  adopt  rules  establishing 
effective  monitoring  mechanisms  and  allowing  effective  enforcement  in  cases  of  non-
compliance.  Monitoring  should  be  based  on  the  control  of  information  prior  to  its 
dissemination  being  made  available,  unless  the  substance  of  the  information  has  already 
been  agreed  by  the  competent  authorities  in  the  course  of  the  marketing  authorisation 
procedures, as it is the case for the summary of the product characteristics, labelling 
and package leaflet, and the publicly accessible version of the assessment report or any 
updated  versions  of  these  documents.  or  if  there  is  a  different  mechanism  in  place  to 
ensure an equivalent level of adequate and effective monitoring. 

(1516) This  Directive  enhances  compliance  with  fundamental  rights  and  is  fully  in  line  with 
the  principles  recognised  by  the  Charter  of  Fundamental  Rights  of  the  European 
Union,  in  particular  Article  11  thereof.  In  this  regard,  this  Directive  does  not  in  any 
way  prevent  Member  States  from  applying  their  constitutional  rules  relating  to 
freedom of the press and freedom of expression in the media.  

(17)  As  this  Directive  introduces  for  the  first  time  harmonised  rules  on  the  provision  of 
information on medicinal products subject to medical prescription to the general public, the 
Commission  should  assess  its  operation  and  the  necessity  for  a  review  five  years  after  its 
entry  into  force.  Provision  should  also  be  made  for  the  drawing  up  of  guidelines  by  the 
Commission based on Member States' experience, in cooperation with stakeholders, in the 
monitoring of information. 

(18)  Recent pharmacovigilance events in the Union have shown the need for an automatic 
procedure at Union level in the cases of specific safety issues to ensure that a matter is 
assessed  and  addressed  in  all  Member  States  where  the  medicinal  product  is 
authorised. The scope of different Union procedures concerning nationally authorised 
products should be clarified. 

(19) 

In addition, voluntary action by the marketing authorisation holder should not lead to 
a situation where concerns related to benefits-risks of a medicinal product authorised 
in  the  Union  are  not  properly  addressed  in  all  Member  States.  Therefore,  provisions 
should  be  made  for  the  marketing  authorisation  holder  to  inform  competent 
authorities of the reasons for the withdrawal of a medicinal product, for interrupting 
the  placing  on  the  market  of  a  medicinal  product,  for  requests  for  revoking  a 
marketing authorisation, or for not renewing a marketing authorisation. 

(20) 

In order to clarify the information allowed, the power to adopt acts in accordance with 
Article  290  of  the  Treaty  on  the  Functionning  of  the  European  Union  should  be 
delegated  to  the  Commission.  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 the Council.  

EN 

14 

   EN 

 
In addition, the Commission should be empowered to adopt implementing measures on 
the quality criteria to be fulfilled by information by the marketing authorisation holder 
to the general public on medicinal products subject to prescription. 

(1621) Since  the  objective  of  this  Directive  to  harmonise  the  rules  on  information  on  medicinal 
products  subject  to  prescription  across  the  Community  Union  cannot  be  sufficiently 
achieved by the Member States and can therefore be better achieved at Community Union 
level,  the  Community  Union  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  Directive  does  not  go  beyond  what  is 
necessary in order to achieve this objective. 

(1722) Directive 2001/83/EC should therefore be amended accordingly, 

HAVE ADOPTED THIS DIRECTIVE: 

Directive 2001/83/EC is amended as follows: 

Article 1 

(1) 

In Article 23a, the second subparagraph is replaced by the following: 

"The holder shall also notify the competent authority 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 two months before the 
interruption  in  the  placing  on  the  market  of  the  product.  The  holder  shall  inform  the 
competent authorities of the reasons for such action in accordance with Article 123." 

(2) 

Article 31 is replaced by the following: 

"Article 31 

1.  The  Member  States,  the  Commission,  the  applicant  or  the  marketing  authorisation 
holder  shall,  in  specific  cases  where  the  interests  of  the  Union  are  involved,  refer  the 
matter to the Committee for application of the procedure laid down in Articles 32, 33 and 
34 before any decision is reached on an application for a marketing authorisation or on the 
suspension  or  revocation  of  a  marketing  authorisation,  or  on  any  other  variation  of  the 
marketing authorisation which appears necessary. 

Where the referral results from the evaluation of data relating to pharmacovigilance of an 
authorised  medicinal  product,  the  matter  shall  be  referred  to  the  Pharmacovigilance  Risk 
Assessment Committee and Article 107j(2) may be applied. The Pharmacovigilance Risk 
Assessment  Committee  shall  issue  a  recommendation  according  to  the  procedure  laid 
down  in  Article  32.  The  final  recommendation  shall  be  forwarded  to  the  Committee  for 
Medicinal  Products  for  Human  Use  or  to  the  coordination  group,  as  appropriate,  and  the 
procedure laid down in Article 107k shall apply. 

However,  where  one  of  the  criteria  listed  in  Article  107i(1)  is  met  urgent  action  is 
considered necessary, the procedure laid down in Articles 107i to 107k shall apply. 

2.  Where  the  referral  to  the  Committee  concerns  a  range  of  medicinal  products  or  a 
therapeutic  class,  the  Agency  may  limit  the  procedure  to  certain  specific  parts  of  the 
authorisation.  

EN 

15 

   EN 

 
 
In that event, Article 35 shall apply to those medicinal products only if they were covered 
by the authorisation procedures referred to in this Chapter. 

Where  the  scope  of  the  procedure  initiated  under  this  Article  concerns  a  range  of 
medicinal products or therapeutic class, medicinal products authorised in accordance 
with  Regulation  (EC)  No  726/2004  which  belong  to  that  range  or  class  shall  also  be 
included in the procedure." 

(3) 

In Article 34(3), the following subparagraph is added: 

"Where  the  scope  of  the  procedure  includes  medicinal  products  authorised  in 
accordance with Regulation (EC) No 726/2004 pursuant to the third subparagraph of 
Article 31(2) of this Directive, the Commission shall where necessary adopt decisions 
to  vary,  suspend,  revoke  or  refuse  renewal  of  the  marketing  authorisations 
concerned". 

(4) 

Article 86 is replaced by the following: 

"Article 86 

1. For the purposes of this Title, 'advertising of medicinal products' shall include any form 
of  door-to-door  information,  canvassing  activity  or  inducement  designed  to  promote  the 
prescription,  supply,  sale  or  consumption  of  medicinal  products  by  the  marketing 
authorisation holder directly or indirectly through a third party acting on his behalf 
or following his instructions; it shall include in particular: 

(a) 

the advertising of medicinal products to the general public, 

(b) 

advertising of medicinal products to persons qualified to prescribe or supply them, 

visits  by  medical  sales  representatives  to  persons  qualified  to  prescribe  medicinal 

(c) 
products, 

(d) 

the supply of samples, 

(e) 
the provision of inducements to prescribe or supply medicinal products by the gift, 
offer or promise of any benefit or bonus, whether in money or in kind, except when their 
intrinsic value is minimal, 

sponsorship  of  promotional  meetings  attended  by  persons  qualified  to  prescribe  or 

(f) 
supply medicinal products, 

sponsorship  of  scientific  congresses  attended  by  persons  qualified  to  prescribe  or 
travelling  and 

(g) 
supply  medicinal  products  and 
accommodation expenses in connection therewith. 

in  particular  payment  of 

their 

Any  reference  to  marketing  authorisation  holders  in  this  Title  shall  include 
marketing authorisation holders and third parties acting on their behalf or following 
their instructions.  

(1) 

Article 86(2) is replaced by the following:  

2. The following are not covered by this Title 

EN 

16 

   EN 

 
the  labelling  and  the  accompanying  package  leaflets,  which  are  subject  to  the 

(a) 
provisions of Title V; 

- factual, informative announcements and reference material relating, for example, to pack 
changes,  adverse-reaction  warnings  as  part  of  general  drug  precautions,  trade  catalogues 
and price lists, provided they include no product claims; 

information relating to human health or diseases, provided that there is no reference, 

(b) 
even indirect, to individual medicinal products; 

(c)  information  by  the  marketing  authorisation  holder  to  the  general  public  on  medicinal 
products  subject  to  medical  prescription,  which  shall  comply  with  is  subject  to  the 
provisions of Title VIIIa. 

(d) 
information by the marketing authorisation holder to investors and employees 
on business developments, provided they are not used to promote medicinal products. 
If  announcements  concern  individual  medicinal  products,  the  provisions  of  Title 
VIIIa shall apply. " 

(25) 

Article 88(4) is replaced by the following: 

"4.  The prohibition set out in paragraph 1 shall not apply to vaccination campaigns and 
other campaigns in the interest of public health carried out by the industry and approved by 
the competent authorities of the Member States. 

Such  vaccination  campaigns  shall  be  approved  by  the  competent  authorities  of  the 
Member States only if it is ensured that objective, non-biased information is provided 
by the industry in the framework of the campaign regarding the efficacy, the adverse 
reactions and contra-indications of the vaccine"; 

(36) 

The heading “TITLE VIIIa “Information and advertising” is deleted; 

(47) 

Article 88a is deleted; 

(58) 

The following Title VIIIa is inserted after Article 100: 

“Title VIIIa – Information to the general public on medicinal products subject to medical 
prescription 

Article 100a  

1.  Member States shall allow the marketing authorisation holder to disseminate, either 
directly  or  indirectly  through  a  third  party,  This  Title  shall  apply  to  information  to  the 
general  public  or  members  thereof  on  authorised  medicinal  products  subject  to  medical 
prescription, which is made available by marketing authorisation holders. provided that 
it is in accordance with the provisions of this Title.  

Any  reference  to  marketing  authorisation  holders  in  this  Title  shall  include 
marketing authorisation holders and third parties acting on their behalf or following 
their instructions.  

Such  iInformation  which  complies  with  the  provisions  of  this  Title  shall  not  be 
considered advertising for the purposes of the application of Title VIII.  

EN 

17 

   EN 

 
2. This Title shall not cover the following: 

(a)  public  announcements  by  marketing  authorisation  holders  relating  to 
information on pharmacovigilance concerns, which are subject to Article 106a; 

(ab)  information relating to human health or diseases, provided that there is no reference, 
even indirect, to individual medicinal products; 

(bc)  material provided by the marketing authorisation holder to healthcare professionals 
for distribution to patients their own use;. 

(d)  information  by  marketing  authorisation  holders  to  investors  and  employees  on 
business  developments,  provided  that  the  information  does  not  concern  individual 
medicinal products and is not used to promote medicinal products. 

3.  Without  prejudice  to  paragraph  1,  when  information  is  made  available  to  the 
public  by  persons  other  than  the  marketing  authorisation  holder,  any  financial  or 
other benefits from marketing authorisation holders shall be declared by the person 
making the information available.  

Article 100b 

1.  The  following  information  on  authorised  medicinal  products  subject  to  medical 
prescription  shall  be  made  available  by  the  marketing  authorisation  holder  to  the 
general public or members thereof: 

the  most  recent  summary  of  the  product  characteristics  as  approved  by  the 

(a) 
competent authorities; 

the  most  recent  labelling  and  package  leaflet  as  approved  by  the  competent 

(b) 
authorities; 

the most recent publicly accessible version of the assessment report as drawn up 

(c) 
by the competent authorities. 

2. The following types of information on authorised medicinal products subject to medical 
prescription may be disseminated made available by the marketing authorisation holder to 
the general public or members thereof: 

(a) the summary of product characteristics, labelling and package leaflet of the medicinal 
product, as approved by the competent authorities, and the publicly accessible version of 
the assessment report drawn up by the competent  authorities; 

(b)  information  which  does  not  go  beyond  the  elements  of  the  summary  of  product 
characteristics, labelling and the package leaflet of the medicinal product, and 
publicly accessible version of the assessment report drawn up by the 
authorities, but presents them in a different way;  

the 
competent 

(ca)  information  on  the  environmental  impact  of  the  medicinal  product  further  to  the 
information  on  the  disposal  and  collection  system  contained  in  the  documents 
referred to in paragraph 1,  

(b) 

information on prices;, 

EN 

18 

   EN 

 
(d  c)  information  on  and  factual,  informative  announcements  and  reference  material 
relating, for example, to pack changes or adverse-reaction warnings; 

(d)  information  on  the  instructions  for  use  of  the  medicinal  product,  further  to  the 
information contained in the documents referred to in paragraph 1;  

(e) information on the pharmaceutical and pre-clinical tests and the clinical trials of 
the medicinal product concerned; 

(f)  a  summary  of  frequently  submitted  requests  for  information  pursuant  to  Article 
100c(c), and the answers to such requests; 

(g) other types of information approved by competent authorities that are relevant to 
support the proper use of the medicinal product. 

The  information  referred  to  in  point  (d)  of  the  first  paragraph  may  be  completed, 
where necessary, with still or moving images of a technical nature demonstrating the 
proper way of using the product. 

(d)  medicinal  product-related  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. 

Article 100c  

Information on authorised medicinal products subject to medical prescription disseminated 
made  available  by  the  marketing  authorisation  holder  to  the  general  public  or  members 
thereof shall not be made available on television, or radio or printed media. It shall only 
be made available through the following channels: 

(a)  printed  materials  about  a  medicinal  product  prepared  by  the  marketing 
authorisation  holder  made  available  to  the  general  public  or  member  thereof  on 
request or through healthcare professionals;health-related publications as defined by the 
Member State of publication, to the exclusion of unsolicited material actively distributed to 
the general public or members thereof; 

internet  websites  on  medicinal  products,  to  the  exclusion  of  unsolicited  material 

(b) 
actively distributed to the general public or members thereof; 

(c)  written answers to specific requests for information about a medicinal product of a 
member of the general public. 

Article 100d 

The  content  and  presentation  of  information  on  authorised  medicinal  products 
1. 
the  marketing 
subject 
authorisation  holder  to  the  general  public  or  members  thereof  shall  fulfil  the  following 
conditions: 

to  medical  prescription  disseminated  made  available  by 

(a) 

(b) 

it must shall be objective and unbiased; in this regard, if the information refers to the 
benefits of a medicinal product, its risks shall also be stated; 

it  must  shall  be  patient-oriented  to  adequately  meet  the  needs  take  into  account 
the general needs and expectations of patients; 

EN 

19 

   EN 

 
(c) 

(d) 

it must shall be based on evidence, be verifiable and include a statement on the level 
of evidence; 

it mustshall be up-to-date and include the date of publication or last revision of the 
information; 

(e) 

it mustshall be reliable, factually correct and not misleading; 

(f) 

(g) 

(h) 

it  mustshall  be  understandable  and  legible  for  the  general  public  or  members 
thereof; 

it  mustshall  clearly  state  the  source  of  the  information  indicating  its  author  and 
giving references to any documentation that the information is based on; 

it  mustshall  not  contradict  the  summary  of  product  characteristics,  labelling  and 
package leaflet of the medicinal product, as approved by the competent authorities. 

2. 

Any information shall include: 

(a) 

(b) 

(c) 

(d) 

(e) 

a  statement  that  the  medicinal  product  concerned  is  available  on  prescription 
only and that instructions for use appear on the package leaflet or on the outer 
packaging, as the case may be; 

a  statement  indicating  that  the  information  is  intended  to  support,  not  to 
replace,  the  relationship  between  patient  and  health  professionals  and  that  a 
health professional should be  contacted if the  patient requires clarification on 
the information provided or further information; 

a statement indicating that the information is disseminated by made available 
by  or  on  behalf  of  or  following  instructions  of  a  named  marketing 
authorisation holder; 

a postal mail address or e-mail address allowing members of the general public 
to  send  comments  to,  or  requests  for  further  information  from,  the 
marketing authorisation holder.; 

a postal address or e-mail address allowing members of the general public 
to contact the competent authorities which have authorised the medicinal 
product; 

(f) 

the text of the most recent package leaflet or an indication as to where that 
text may be found. 

3. 

The information shall not include: 

(a) 

comparisons between medicinal products; 

(b) 

any of the material referred to in Article 90. 

4. 
In  order  to  ensure  the  quality  of  information  made  available  to  the  general 
public and members thereof, Tthe Commission shall adopt, by means of implementing 
acts,  the  measures  necessary  for  the  implementation  of  paragraphs  1,  2  and  3.  Those 
implementing acts shall be adopted in accordance with the procedure referred to in 
Article 121(2).  

EN 

20 

   EN 

 
Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive  by 
supplementing  it,  shall  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny referred to in Article 121(2a). 

Article 100e 

1.  Member  States  shall  ensure  that  marketing  authorisation  holders'  Internet  websites 
for  the  dissemination  of  on  which  information  on  medicinal  products  subject  to  medical 
prescription are making available reproduce the documents referred to in Article 100b 
(1).  the  summary  of  product  characteristics  and  the  package  leaflet  of  the  medicinal 
products  concerned  in  the  official  languages  of  the  Member  States  where  they  are 
authorised. 

2.  Member  States  shall  ensure  that  requests  for  information  to  a  marketing 
authorisation holder on a medicinal product subject to medical prescription by a member of 
the general public may be drafted in any of the official languages of the Community Union 
which  are  official  languages  in  the  Member  States  where  the  medicinal  product  is 
authorised. The reply shall be drafted in the language of the request. 

Article 100f 

1.  Member  States  shall,  without  creating  a  disproportionate  burden  for  the  marketing 
authorisation  holder,  ensure  that  marketing  authorisation  holders  make  information 
provided in accordance with this Title accessible to persons with disabilities. 

2. 
To ensure accessibility of information on a medicinal product provided by marketing 
authorisation  holders  through  the  Internet,  the  websites  concerned  shall  conform  to  the 
World  Wide  Web  Consortium’s  (W3C)  Web  Content  Accessibility  Guidelines  version 
12.0, Level A. The Commission shall make those guidelines publicly available. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 121a and subject to the conditions of Articles 121b and 121c to may amend this 
paragraph  to  take  account  of  technical  progress  This  measure,  designed  to  amend  non-
essential  elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 121(2a).  

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Article 100g 

1.  Member  States  shall  ensure  that  there  are  adequate  and  effective  methods  of 
monitoring to avoid misuse when information on authorised medicinal products subject to 
medical prescription is disseminated made available by the marketing authorisation holder 
to the general public or members thereof after it has been approved by the competent 
authorities.  

However,  the  documents  referred  to  in  Article  100b(1)  shall  not  require  further 
approval before they are made available to the general public or members thereof in 
addition to their approval in the context of a marketing authorisation procedure. 

2.  By  way  of  derogation  from  paragraph  1,  Member  States  may  rely  on  other 
mechanisms for the control of information after it has been made available, on any of 
the following grounds:  

(a) 

such mechanisms already existed on 31 December 2008, 

(b)  a system of control of information before it is made available is not compatible 
with the constitutional rules of the Member State concerned. 

Such  mechanismsthods  shall  ensure  be  based  on  the  control  of  information  prior  to  its 
dissemination, unless  

- the content of the information has already been approved by the competent authorities; or 

-  an  equivalent  a  level  of  adequate  and  effective  control  monitoring  equivalent  to  the 
approval referred to in paragraph 1 is ensured through a different mechanism. 

The methods may include the voluntary control of information on medicinal products by 
self-regulatory or co-regulatory bodies and recourse to such bodies, if proceedings before 
such bodies are possible in addition to the judicial or administrative proceedings available 
in the Member States. 

23. After consulting the Member States and stakeholders, the Commission shall draw up 
guidelines  concerning  information  allowed  under  this  Title  and  containing  a  code  of 
conduct for marketing authorisation holders providing information to the general public or 
members  thereof  on  authorised  medicinal  products  subject  to  medical  prescription.The 
Commission  shall  draw  up  these  guidelines  on  the  entry  into  force  of  this  directive  and 
update them regularly on the basis of the experience gained. 

Article 100h 

1.  Member  States  shall  ensure  that  marketing  authorisation  holders  register  Internet 
websites  containing  information  on  medicinal  products  with  the  national  competent 
authorities  of  the  Member  State  of  the  country  code  Top  Level  Domain  used  by  the 
website  concerned,  prior  to  making  it  available  to  the  general  public.  Where  the  website 
does not use a country code Top Level Domain, the marketing authorisation holder shall 
select the Member State of registration.  

After registration of the Internet website, the information on a medicinal product contained 
therein may be provided by the marketing authorisation holders on other of their Internet 

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websites  containing  information  on  medicinal  products  throughout  the  Community 
Union if the contents are identical. 

2. 
Internet websites registered in accordance with paragraph 1 shall not contain links to 
other  marketing  authorisation  holder  websites  unless  they  have  also  been  registered  in 
accordance  with  that  paragraph.  Those  websites  shall  identify  the  competent  authority 
which granted the marketing authorisation and its website address. 

Internet  websites  registered  in  accordance  with  paragraph  1  shall  not  allow  the 
identification of members of the general public which have access to those websites or the 
appearance therein of unsolicited material content actively distributed to the general public 
or members thereof. Those websites shall not contain web-TV. 

The  Member  State  where  the  Internet  website  has  been  registered  shall  be 
3. 
responsible  for  the  control  of  the  information  made  available  at  the  time  of 
registration  and  of  subsequent  information  in  accordance  with  Article  100g  and  for 
the  monitoring  of  such  information,  in  accordance  with  Article  100j  of  the  contents 
disseminated on that website. 

4. 
A  Member  State  shall  not  adopt  any  measure  with  regard  to  the  content  of  an 
Internet  website  which  reproduces  an  Internet  website  registered  with  the  national 
competent authorities of another Member State, except on the following grounds:  

(a)  If  the  Member  State  of  registration  monitors  the  information  after  it  has  been 
made available in accordance with Article 100g(2), a Member State may require that 
the information is approved by the competent authorities before it is reproduced on a 
website in that Member State; 

(b)  If  a  Member  State  has  reasons  for  doubts  as  to  whether  the  translation  of  the 
reproduced  information  is  correct,  it  may  require  a  marketing  authorisation  holder  to 
provide for a certified translation of the information disseminated made available on the 
Internet website registered with the national competent authority of another Member State. 

(cb)  If a Member State has reasons for doubts as to whether the information disseminated 
made available on an Internet website registered with the national competent authorities 
of another Member State complies with the requirements of this Title, it shall inform that 
Member State of the reasons for its doubts. The Member States concerned 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  Decision  75/320/EEC.  Any  necessary  measures  may  only  be  adopted  after  an 
opinion  has  been  delivered  by  that  Committee.  Member  States  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.  Member  States  shall  allow  require  marketing  authorisation  holders  which  have 
registered Internet websites in accordance with paragraphs 1 to 4 to include the following 
therein: 

(a)  in  addition  to  the  statements  listed  in  Article  100d(2),  a  statement  therein  to  the 
effect that the site has been registered and is subject to monitoring in accordance with this 
Directive.  The  statement  shall  identify  the  national  competent  authority  monitoring  the 
website concerned. In cases where the information is not subject to approval prior to 
its being made available pursuant to Article 100g(2), Iit shall also specify that the fact 

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23 

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that  the  website  is  registered  and  monitored  does  not  necessarily  mean  that  all  the 
information on the website has been subject to prior approval.  

(b)  a  link  to  the  European  medicines  web  portal  referred  to  in  Article  26  of 
Regulation (EC) No 726/2004.  

6. Member States shall ensure that information on medicinal products authorised in 
accordance  with  Regulation  (EC)  No  726/2004  is  not  made  available  on  Internet 
websites  that  they  have  registered  until  the  information  has  been  approved  by  the 
Agency in accordance with Articles 20b and 20c of that Regulation.  

Article 100i 

1.  Member States shall take appropriate measures to ensure that the provisions of this 
Title  are  applied  and  that  adequate  and  effective  measures  are  adopted  to  sanction  non-
compliance with those provisions. Such measures shall include the following:  

(a) 

the determination of the penalties which shall be imposed should the provisions 
adopted for the implementation of this Title be infringed; 

(b) 

the obligation to sanction cases of non-compliance; 

(c) 

the conferment  of powers  on  the courts or administrative authorities  enabling 
them to order the cessation of dissemination of making available information 
that  does  not  comply  with  this  Title  or,  if  such  information  has  not  been 
disseminated made available but dissemination this is imminent, to prohibit 
the  making  available  of  such  information  order  prohibition  of  such 
dissemination; 

(d) 

the  possibility  to  publish  the  name  of  marketing  authorisation  holders 
responsible for making available information not compliant with this Title. 

2.  Member States shall make provision for the measures referred to in paragraph 1 to be 
taken under an accelerated procedure either with interim effect or with definitive effect.  

3.  Member  States  shall  ensure  that  marketing  authorisation  holders  are 
represented  and  heard  in  any  consideration  of  a  case  in  which  they  are  accused  of 
non-compliance with the provisions set out in this Title. The marketing authorisation 
holders shall have the right to appeal any decision to a judicial or other body. During 
the appeal procedure the making available of information shall be suspended until a 
decision to the contrary is taken by the responsible body. 

Article 100j 

Member  States  shall  ensure  that  marketing  authorisation  holders,  through  the  scientific 
service referred to in Article 98(1): 

keep  available  for  the  competent  authorities  or  bodies  responsible  for  monitoring 
(a) 
information  on  medicinal  products,  a  sample  of  all  information  disseminated  made 
available  in  accordance  with  this  Title  and  information  on  its  volume  of  dissemination, 
together  with  a  statement  indicating  the  persons  to  whom  it  is  addressed,  the  method  of 
dissemination communication and the date on which the information was of first made 
availabledissemination, 

EN 

24 

   EN 

 
(b)  keep  available  for  the  competent  authorities  responsible  for  monitoring 
information  on  medicinal  products,  the  replies  made  in  accordance  with  this  Title 
together with a statement indicating the persons to whom they are addressed, 

(bc)  ensure  that  information  on  medicinal  products  by  their  undertaking  complies  with 
the requirements of this Title; 

(cd)  supply the authorities or bodies responsible for monitoring information on medicinal 
products with the information and assistance they require to carry out their responsibilities; 

(de)  ensure  that  the  decisions  taken  by  the  authorities  or  bodies  responsible  for 
monitoring information on medicinal products are immediately and fully complied with. 

Article 100k 

Information on homeopathic medicinal products referred to in Article 14(1) that have been 
classified as prescription-only shall be subject to the provisions of this Title.  

Article 100l 

By  [insert specific date five years from the entry into force of amending directive] at the 
latest,  the  Commission  shall  publish  a  report  on  the  experience  acquired  in  the 
implementation of this Title, after consultation of stakeholders, and shall also assess the 
need  for  a  review  thereof.  The  Commission  shall  submit  this  report  to  the  European 
Parliament and to the Council." 

(9) 

(10) 

In Article 121a(1), the words "Article 22b, 47, 52b and 54a" are replaced by "Articles 
22b, 47, 52b, 54a and 100f (2)". 

In  Article  121b(1),  the  words  "Articles  22b,  47,  52b  and  54a"  are  replaced  by  " 
Articles 22b, 47, 52b, 54a and 100f(2)". 

(11) 

In Article 106, the following first sub-paragraph is inserted: 

"Each  Member  States  shall  ensure  that  objective,  unbiased  information  is  made 
available to general public or members thereof on medicinal products placed on the 
market on its territory". 

(12) 

Article 107i(1) is replaced by the following: 

"1.  A  Member  State  or  the  Commission,  as  appropriate,  shall  initiate  the  procedure 
provided  for  in  this  section,  by  informing  the  other  Member  States,  the  Agency  and  the 
Commission  when  urgent  action  is  considered  necessary,  as  a  result  of  the  evaluation  of 
data resulting from pharmacovigilance activities, in any of the following cases: 

(a) it considers suspending or revoking a marketing authorisation; 

(b) it considers prohibiting the supply of a medicinal product; 

(c) it considers refusing the renewal of a marketing authorisation; 

(d)  it  is  informed  by  the  marketing  authorisation  holder  that,  on  the  basis  of  safety 
concerns, he has interrupted the placing on the market of a medicinal product or has taken 

EN 

25 

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action to have a marketing authorisation withdrawn, or that he intends to do so, or has not 
applied for the renewal of a marketing authorisation; 

(e)  it  considers  that  a  new  contraindication,  a  reduction  in  the  recommended  dose,  or  a 
restriction to the indications is necessary. 

The  Agency  shall  verify  whether  the  safety  concern  relates  to  medicinal  products  other 
than the one covered by the information, or whether it is common to all products belonging 
to the same range or therapeutic class. 

Where the medicinal product involved is authorised in more than one Member State, the 
Agency shall without undue delay inform the initiator of the procedure of the outcome of 
this  verification,  and  the  procedures  laid  down  in  Articles  107j  and  107k  shall  apply. 
Otherwise,  the  safety  concern  shall  be  addressed  by  the  Member  State  concerned.  The 
Agency or the Member State, as applicable, shall make information that the procedure has 
been initiated available to marketing authorisation holders." 

(13) 

Article 123(2) is replaced by the following: 

"2.  The  marketing  authorization  holder  shall  be  obliged  to  notify  the  Member  States 
concerned forthwith of any action taken by him to suspend the marketing of a medicinal 
product, or 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. if the latter concerns the efficacy of the medicinal product or the 
protection of public health. In such case, Member States shall ensure that this information 
is brought to the attention of the Agency." 

Article 2 

1. 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary  to  comply  with  this  Directive  by  [12  months  after  publication  in  the  Official 
Journal;  exact  date  inserted  at  time  of  publication]  at  the  latest.  They  shall  forthwith 
communicate  to  the  Commission  the  text  of  those  provisions  and  a  correlation  table 
between those provisions and this Directive. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member  States  shall  communicate  to  the  Commission  the  text  of  the  main  provisions  of 
national law which they adopt in the field covered by this Directive. 

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

Article 3 

EN 

26 

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Article 4 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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27 

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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 

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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 structure6  

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 action7  

(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.. 

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

6 
7 

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

EN 

29 

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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.  

1.5. 

Grounds for the proposal/initiative  

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30 

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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, 

–  followed by full-scale operation. 

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1.7.  Management mode(s) envisaged8  

(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 Communities9 : 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.  

8 

9 

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. 

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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 
the  OLAF  was  already  adopted  on  1  June  1999 
decision  concerning  co-operation  with 
(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. 

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3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1. 

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 
(10) 

from 
EFTA11 
countries 

from 
candidate 
countries12 

from third 
countries 

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

Heading of 
multiannual 
financial 
framework 

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 

10 
11 
12 

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 

34 

   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 programs14  
Number of budget line 

an 

administrative 

TOTAL appropriations 
for DG <.> 

Year 
201613 

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 

13 
14 

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. 

35 

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 

36 

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 
201615 

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) 

15 

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

EN 

37 

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 
output16 

(cid:216) 

Aver
age 
cost  
of the 
ouput 

SPECIFIC OBJECTIVE No 117… 

- Output 

- Output 

- Output 

Sub-total for specific objective N°1 

SPECIFIC OBJECTIVE No 2… 

- Output 

Sub-total for specific objective N°2 

TOTAL COST 

16 
17 

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 

38 

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 

39 

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 

40 

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 plan18 

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

18 

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

EN 

41 

EN 

 
  
 
 
 
 
 
 
 
 
                                                 
Cost of translation into English19 

569 100

569 100

569 100

650 400 

650 400

650 400

Cost  of 
submission language19 

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 costs20 

Income fees21 

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.  

19 
20 
21 

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

EN 

42 

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 22 

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 523 
of the multiannual 
financial framework  

Human resources  

Other expenditure  
of an administrative 
nature 

Subtotal  
outside HEADING 5 
of the multiannual 
financial framework  

TOTAL 

22 
23 

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 

43 

   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)24 

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 25 

- at Headquarters26 

- 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 

24 

25 
26 

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 

44 

   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 framework27. 

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  

27 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

45 

   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/initiative28 

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. 

… 

28 

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 

46 

   EN