Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source {SEC(2008) 2674} {SEC(2008) 2675}
Date: 2008-12-10
Institutions: European Commission
Subjects: approximation of laws, legal code, medicinal product, pharmaceutical legislation, public health, single market

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 10.12.2008 
COM(2008) 668 final 

2008/0261 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Directive 2001/83/EC as regards the prevention of the entry into the legal 
supply chain of medicinal products which are falsified in relation to their identity, 
history or source 

{SEC(2008) 2674} 
{SEC(2008) 2675} 

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EXPLANATORY MEMORANDUM 

1. 

BACKGROUND TO THE PROPOSAL 

There is an alarming increase in the EU of medicinal products which are falsified in 
relation to their identity, history or source. These products are from the point of view 
of  EU  pharmaceutical  legislation  illegal  insofar  as  they  do  not  comply  with  the 
Community  rules  for  medicinal  products.  Therefore,  in  the  context  of  this  proposal 
for an amendment of the pharmaceutical legislation these products shall be referred 
to as “falsified medicinal products”.  

Falsified medicinal products may contain sub-standard or falsified ingredients, or no 
ingredients  or  ingredients  in  the  wrong  dosage,  including  active  ingredients.  They 
pose a major threat to European patients and European industry and there are strong 
concerns in the public and amongst policy makers about the steady increase of these 
products detected in the EU in the last years. 

The  potential  threat  to  public  health  is  also  recognised  by  the  World  Health 
Organisation  (WHO),  who  set  up  the  International  Medical  Products  Anti-
Counterfeiting  Taskforce 
IMPACT  developed,  with  active 
participation  of  the  Community,  Principles  and  Elements  for  National  Legislation 
against Counterfeit Medical Products, which were endorsed by the IMPACT General 
Meeting  in  Lisbon  on  12  December  2007.  The  efforts  of  IMPACT  have  been 
welcomed in the summit declaration of the Group of Eight (G8) on 7 June 2008. 

("IMPACT"). 

To  this  adds  that  the  risk  profile  has  changed.  The  number  of  falsifications  of 
innovative  and  life-saving  medicines  is  increasing.  Moreover,  in  order  to  increase 
volume, these  products are channelled through the lawful supply chain towards the 
patient. In this way, in 2007, many thousand packs of falsified life-saving drugs have 
reached patients in the EU. 

While  there  is  uncertainty  as  to  the  precise  number  of  cases  today  or  in  the  future, 
there  is  a  clear  trend  visible  which  threatens  the  high  level  of  protection  of  public 
health  in  the  EU.  This  trend  can  have  disastrous  consequences  for  the  trust  of  the 
public  in  the  industry  and  in  the  policy  maker – well  comparable  to  the  “food-and-
feed crisis” of the 1990’s. 

The  underlying  causes  for  falsified  medicinal  products  remaining  undetected  in  the 
lawful supply chain are manifold, but can be reduced to four aspects: 

(cid:121) 

(cid:121) 

(cid:121) 

Falsified  medicinal  products  can  not  always  be  easily  distinguished  from 
originals; 

The distribution chain has become very complex and is only as “strong as its 
weakest link”; 

There are legal uncertainties as to the regime applicable to products introduced 
into the EU while allegedly not being placed on the market; and 

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(cid:121) 

Already 
manufacturing process may be a falsification of the original API. 

the  active  pharmaceutical 

ingredients 

(“API”)  entering 

the 

The existing provisions of 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 use1 are in some respects insufficient to address these concrete 
causes.  In  view  of  the  time  span  between  the  proposal  of  changes  to  Directive 
2001/83/EC  and  their  effective  implementation,  there  is  a  clear  need  for  the 
Commission to act now. 

2. 

PUBLIC CONSULTATION  

In preparation of the impact assessment for this proposal, the Commission had held, 
from 11 March 2008 to 9 May 2008 a public consultation on “Key ideas for better 
protection  of  patients  against  the  risk  of  counterfeit  medicines”.  In  response  to  this 
consultation,  the  Commission  received  128  contributions  from  stakeholders.  Of 
these,  103  were  from  industry  (pharmaceutical  industry,  distributors,  suppliers  of 
active  ingredients,  consultants),  15  from  citizens,  patient  (groups),  and  academics, 
and 10 from health professionals, pharmacists and health insurers. 

Of  the  128  stakeholder  contributions,  in  terms  of  regions,  20  contributions  were 
received  from  EU-wide  associations,  30  from  Italy,  14  from  the  UK,  9  from 
Germany, 4 each from France and Switzerland, 3 each from Poland and Ireland and 
the Netherlands, 2 each from Malta, and Denmark, 1 each from Austria, Sweden and 
Spain, and 18 from non-European third countries. 13 stakeholder contributions were 
global associations or could not be attributed in terms of region. 

30  national  and  regional  authorities  profited  from  this  stakeholder-consultation  to 
inform the Commission of their views on the matter. 

The  respondents  unanimously  welcomed  the  initiative  stressing  that  urgent  and 
decisive  action  was  needed,  and  that  the  problem  of  falsified  medicinal  products  is 
increasing exponentially. Moreover, the “multi-layer” approach by the Commission, 
based  on  an  identification  of  the  various  possible  points  of  entry  for  falsified 
medicines  was  welcomed.  A  summary  of  the  responses  has  been  published  on  the 
Commission website2. 

3. 

IMPACT ASSESSMENT 

The  Commission  conducted  an  impact  assessment  in  accordance  with  the 
Commission  impact  assessment  guidelines  and  published  the  results  in  an  impact 
assessment report. 

The  impact  assessment  report  identifies  and  assesses  policy  options  to  achieve  the 
objective, which is defined as eliminating, by all practical means, the risk of falsified 
medicines entering the legal supply chain. 

1 
2 

OJ L 311, 28.11.2001, p. 67. 
http://ec.europa.eu/enterprise/pharmaceuticals/counterf_par_trade/counterfeit_key.htm  

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The assessment of the policy options is made against a baseline of “non-action”. For 
this baseline, various scenarios of the future development of falsified medicines for 
the period until 2020 have been developed. While these scenarios (and related costs) 
are by their very nature estimations based on best use of existing  data (which is in 
itself limited), they reveal that societal direct and indirect costs of non action could 
reach, depending on the scenario, between 9.5bn EUR and 116bn EUR until 2020. 

These  costs  of  non-action  compare  against  the  costs  of  the  chosen  policy  options. 
These costs are estimated to be, until 2020, as follows: 

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

For  manufacturers  and  importers  of  medicinal  products:  between  6.8bn EUR 
and  11bn EUR,  depending  on  the  safety  technique  chosen.  The  costs  for 
distributors who remove/exchange safety features depend on the extent of their 
activity. Moreover, depending on the chosen approach, pharmacies are going to 
bear costs of approx. 157m EUR. 

For wholesale distributors of medicinal products: approx. 280m EUR; 

For  wholesale  distributors  who  engage  only  in  export  activity:  approx. 
403m EUR; 

For other traders situated in the distribution chain: approx. 5m EUR; 

For manufacturers of API: approx. 320m EUR. The bulk of these costs is going 
to fall upon 3rd country manufacturers. 

4. 

LEGAL BASIS AND SUBSIDIARITY 

The  aim  of  Directive  2001/83/EC,  as  well  as  this  proposed  amendment,  is  to 
establish the functioning of the internal market for medicinal products while ensuring 
a high level of protection of public health in the EU. The legal basis is thus Article 
95 of the Treaty. 

To the extent that Directive 2001/83/EC establishes exhaustive rules, Member States 
are  not  allowed  to  “add  to”  these  rules.  Moreover,  the  aim  to  combat  falsified 
medicinal  products  in  the  legal  supply  chain  without  hampering  the  functioning  of 
the  internal  market  for  medicinal  products  cannot  be  sufficiently  achieved  by  the 
Member States and can be better achieved by the Community. 

5. 

AMENDMENTS 

In order to address the risk of falsified medicinal products entering the legal supply 
chain, the Commission proposes a number of amendments to Directive 2001/83/EC. 
These include: 

(cid:121) 

Certain obligations for other players than wholesale distributors, who act in the 
distribution  chain.  These  actors  are  typically  involved  in  the  transactions 
without  actually  handling  the  products  (for  example,  by  auctioning  or 
brokering products, cf. Article 1(14) of the proposed amending Directive). 

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(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

A legal basis for the Commission to render obligatory specific safety-features 
(such  as  a  serialisation  number  or  a  seal)  on  the  packaging  of  prescription-
medicines (Article 1(8) of the proposed amending Directive). 

A  prohibition  in  principle  of  manipulating  (i.e.  removing,  tampering  with,  or 
over-labelling)  safety  features  on  the  packaging  by  actors  situated  “in-
between” the original manufacturer and the last actor in the distribution chain 
(typically the pharmacist) or end user (doctor/patient). 

Obligatory audits of supplying wholesale distributors of medicinal products in 
order  to  ensure  reliability  of  business  partners  (Article  1(13)  of  the  proposed 
amending Directive). 

Strengthened  requirements for imports of API from  third countries if it  could 
not be established that the regulatory framework in the respective third country 
ensures a sufficient level of protection of human health for products exported 
to the EU (Article 1(4) of the proposed amending Directive). 

Audits  of  manufacturers  of  API  (Article  1(3)(a)  of  the  proposed  amending 
Directive). 

Strengthened  rules  for  inspections  including  increased  transparency  of 
inspection results through publication in the EudraGMP database managed by 
the EMEA (Article 1(15) of the proposed amending Directive). 

With regards to the impact on economic operators, the Commission, when choosing 
the policy options, took care to 

(cid:121) 

(cid:121) 

(cid:121) 

keep  any  increase  of  costs  for  compliance  (incl.  administrative  costs)  to  the 
minimum necessary to achieve the aim; 

allow,  where  possible,  for  flexibility  so  that  the  regulatory  framework  can  be 
adapted to a changing risk-profile; and 

spread  the  responsibility  amongst  all  actors,  i.e.  not  just  the  pharmaceutical 
industry as such but also wholesalers, API-suppliers and importers. 

A detailed discussion of the proposed amendments, including an assessment of their 
socio-economic impact, is contained in the impact assessment report. 

6. 

CONSISTENCY WITH OTHER COMMUNITY POLICIES 

The  proposal  is  part  of  the  Community  strategy  for  safe,  innovative  and  accessible 
medicines, as presented by the Commission in its Communication to the Council, the 
European  Parliament  and  the  European  Economic  and  Social  Committee:  “Safe, 
innovative  and  Accessible  Medicines:  a  Renewed  Vision  for  the  Pharmaceutical 
Sector”3.  The  proposal  is  also  in  line  with  the  Commission’s  strategic  objective  to 

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COM(2008) . 

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protect  citizens  from  health  threats  as  set  out  in  the  Commission  White  Paper 
“Together for Health: A strategic approach for the EU 2008-2013”.4 

7. 

BUDGETARY IMPLICATION 

It is proposed to extend the Community-database of GMP5-compliant companies to 
GDP6-compliant wholesale distributors (cf. above, point 5, 7th bullet). As set out in 
the legislative financial statement annexed to the proposal, these IT-related measures 
are not expected to have budgetary implications. 

8. 

ADDITIONAL INFORMATION 

The  proposal  concerns  an  EEA  matter  and  therefore  extends  to  the  European 
Economic Area. 

4 
5 
6 

COM(2007) 630 . 
Good Manufacturing Practices. 
Good Distribution Practices. 

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2008/0261 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Directive 2001/83/EC as regards the prevention of the entry into the legal 
supply chain of medicinal products which are falsified in relation to their identity, 
history or source 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 

Having regard to the proposal from the Commission7, 

Having regard to the opinion of the European Economic and Social Committee8, 

Having regard to the opinion of the Committee of the Regions9, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty10, 

Whereas: 

(1) 

(2) 

(3) 

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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  use11  lays 
down  the rules for inter alia manufacturing, importation, placing  on  the  market,  and 
wholesale  distribution  of  medicinal  products  in  the  Community  as  well  as  rules 
relating to active pharmaceutical ingredients used as starting materials. 

There is an alarming increase of medicinal products detected in the Community which 
are  falsified  in  relation  to  their  identity,  history  or  source.  These  products  usually 
contain  sub-standard  or  falsified  ingredients,  or  no  ingredients  or  ingredients  in  the 
wrong dosage, including active ingredients, thus posing an important threat to public 
health. 

Past  experience  shows  that  such  medicinal  products  are  not  only  marketed  through 
illegal  supply  chains,  but  reach  the  patient  via  the  legal  supply  chain  as  well.  This 
poses a particular threat to human health and may lead to a lack of trust of the patient 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 311, 28.11.2001, p. 67. 

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in  the  legal  supply  chain.  The  rules  contained  in  Directive  2001/83/EC  should  be 
amended in order to respond to this increasing threat. 

The  potential  threat  to  public  health  is  also  recognised  by  the  World  Health 
the  International  Medical  Products  Anti-
Organisation  (WHO),  who  set  up 
Counterfeiting  Taskforce  ("IMPACT").  IMPACT  developed,  with 
the  active 
participation  of  the  Community,  Principles  and  Elements  for  National  Legislation 
against Counterfeit Medical Products, which were endorsed by the IMPACT General 
Meeting in Lisbon on 12 December 2007.  

Today’s  distribution  network  for  medicinal  products  is  increasingly  complex  and 
involves many players which are not necessarily wholesale distributors as defined in 
Directive  2001/83/EC.  In  order  to  ensure  reliability  in  the  distribution  chain, 
pharmaceutical  legislation  should  address  all  actors  in  the  distribution  chain:  this 
includes not only  distributors who procure, hold, store and supply products, but  also 
persons who are involved in transactions without handling the products. They should 
be  submitted  to  proportionate  rules  in  order  to  exclude,  by  all  practical  means,  the 
possibility  that  medicinal  products  which  are  falsified  in  relation  to  their  identity, 
history or source to enter the legal supply chain in the Community. 

Directive  2001/83/EC  applies  also  to  wholesale  distributors  which  do  not  place 
medicinal  products  on  the  market  but  export  them.  The  rules  applicable  to  those 
wholesale  distributors – which  apply  no  matter  whether  the  exported  product  is 
intended to be imported, i.e. placed on the market or merely introduced without being 
imported - should be clarified. 

In  order  to  take  account  of  new  risk  profiles,  while  at  the  same  time  ensuring  the 
functioning of the internal market for medicinal products, safety features designed to 
ensure  the  identification,  authentication  and  traceability  of  prescription  medicinal 
products  should  be  established  at  Community  level.  When  introducing  obligatory 
safety features for prescription medicinal products, due account should be taken of the 
particularities of certain products or categories of products, such as generic medicines. 
This includes the risk of falsifications in view of their price and past incidences in the 
Community and abroad, as well as the consequences of falsifications for public health 
in view of the specific characteristics of the products concerned or of the severity of 
the conditions intended to be treated. 

Any actor in the supply chain who packages medicinal products has to be a holder of a 
manufacturing  authorization.  In  order  for  the  safety  features  to  be  effective,  the 
manufacturing  authorization  holder  should  only  be  permitted  to  remove,  replace  or 
cover these features under strict conditions. 

These manufacturing authorisation holders should be held strictly liable for damages 
to  patients  caused  by  products  placed  by  them  on  the  market  which  are  falsified  in 
relation to their identity. 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

In order to increase reliability in the distribution chain, wholesale distributors should 
verify,  either  by  themselves  or  through  a  body  accredited  for  that  purpose,  that  their 
suppliers comply with good distribution practices.  

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(11)  To ensure transparency, a list of those wholesale distributors whose compliance with 
applicable  Community  rules  has  been  established  after  inspection  by  a  competent 
authority of a Member State, should be published in a Community database. 

(12)  Falsified  active  pharmaceutical  ingredients  pose  the  risk  of  sub-standard  active 
pharmaceutical ingredients. This risk should be addressed. In particular, manufacturers 
of medicinal products should ensure either by themselves of through a body accredited 
for that purpose that the supplying manufacturer of active pharmaceutical ingredients 
complies with good manufacturing practices. 

(13)  The  manufacture  of  active  pharmaceutical  ingredients  should  be  subject  to  good 
manufacturing practices irrespective of whether those ingredients were manufactured 
in  the  Community  or  imported.  With  regard  to  the  manufacture  of  active 
pharmaceutical ingredients in third countries, it should be ensured that the rules for the 
manufacture  of  active  pharmaceutical  ingredients  intended  for  export  to  the 
Community, including inspection and enforcement, provide for a level of protection of 
public health equivalent to that provided for by Community legislation. 

(14) 

In  order  to  facilitate  enforcement  and  control  of  Community  rules  relating  to  active 
substances  used  as  starting  material,  the  manufacturers  or  importers  of  those 
substances should notify their activity. 

(15)  To  ensure  a  similar  level  of  protection  of  human  health  throughout  the  Community, 
and  to  avoid  distortions  in  the  internal  market,  the  harmonised  principles  and 
guidelines  for  inspections  of  holders  of  manufacturing  and  wholesaler  authorisations 
of  medicinal  products  as  well  as  manufacturers  of  active  substances  should  be 
strengthened.  This  should  also  help  to  ensure  the  functioning  of  existing  mutual 
recognition  agreements  which  rely  on  efficient  and  comparable  inspection  and 
enforcement throughout the Community. 

(16)  The measures necessary for the implementation of this Directive should be adopted in 
accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures for the exercise of implementing powers conferred by the Commission12. 

(17) 

In  particular  the  Commission  should  be  empowered  to  adopt  measures  regarding 
safety  features  that  shall  appear  on  the  packaging  of  medicinal  products  subject  to 
medical  prescription  and  to  adopt  detailed  rules  for  medicinal  products  introduced 
without being placed on the market. Since those measures are of general scope and are 
designed to amend non-essential elements by supplementing it, they must be adopted 
in accordance with the regulatory procedure with scrutiny provided for in Article 5a of 
Decision 1999/468/EC. 

(18)  Since  the  objective  of  ensuring  the  functioning  of  the  internal  market  for  medicinal 
products, while ensuring a high level of protection of public health against medicinal 
products which are illegal in view of a falsified identity, history or source, cannot be 
sufficiently  achieved  by  the  Member  States,  as  they  cannot  adopt  individually 
harmonised  measures  applicable  in  the  Community  and  can  be  better  achieved  by 
action at Community level, the Community may adopt measures, in accordance with 

12 

OJ L 184, 17.7.1999, p. 23. 

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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 that objective. 

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

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 2001/83/EC is amended as follows: 

1) 

In Article 1, the following point 17a is inserted after point 17: 

‘17a. Trading of medicinal products: 

All activities consisting of negotiating independently on behalf of another person the 
sale  or  the  purchase  of  medicinal  products,  or  billing  or  brokering  medicinal 
products,  apart  from  supplying  medicinal  products  to  the  public,  and  not  falling 
under the definition of wholesale distribution.’ 

2) 

In Article 2, paragraph 3 is replaced by the following: 

‘(3)  Notwithstanding paragraph 1 and Article 3(4), Title IV of this Directive shall 
apply  to  medicinal  products  intended  only  for  export  and  to  intermediate  products 
and active substances used as starting materials.’ 

3) 

Article 46 is amended as follows: 

(a)  The first subparagraph of point (f) is replaced by the following: 

‘(f) 
to  comply  with  the  principles  and  guidelines  of  good  manufacturing 
practice  for  medicinal  products  and  to  use  as  starting  materials  only  active 
substances,  which  have  been  manufactured  in  accordance  with  the  detailed 
guidelines on good manufacturing practice for starting materials. To this end, 
the  holder  of  the  manufacturing  authorization  shall  verify  compliance  of  the 
active substances manufacturer with good manufacturing practices by himself 
or through a body accredited for this purpose by the competent authority of a 
Member State.’ 

(b)  The following point (g) is added: 

to  inform  the  competent  authority  of  products  he  gets  knowledge  of 
‘(g) 
which  are  or  which  are  suspected  to  be  falsified  in  relation  to  the  identity, 
history or source of products manufactured by him .’ 

4) 

The following Article 46b is inserted after Article 46a: 

‘Article 46b 

(1)  Member States shall take appropriate measures to ensure that the manufacture 
on  their  territory  of  active  substances  used  as  starting  material,  including  active 

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substances that are intended for export, complies with good manufacturing practices 
for active substances. 

(2)  Active substances used as starting material shall only be imported if: 

(a) 

(b) 

they  have  been  manufactured  by  applying  standards  of  good 
manufacturing  practice  at  least  equivalent  to  those  laid  down  by  the 
Community; and 

they are accompanied by a written confirmation from the exporting third 
country  that  the  standards  of  good  manufacturing  practice  applicable  to 
the  plant  manufacturing  the  exported  active  substance  are  at  least 
equivalent  to  those  laid  down  by  the  Community,  and  that  the  plant  is 
subject 
those  good 
manufacturing practices cannot be circumvented. 

to  control  and  enforcement  ensuring 

that 

(3)  The  requirement  set  out  in  point  (b)  of  paragraph  2  shall  not  apply  if  the 
exporting country is listed in accordance with Article 111b.’ 

5) 

In Article 47, the third paragraph is replaced by the following: 

‘The principles of good manufacturing practice for active substances used as starting 
materials referred to in point (f) of Article 46 and in Article 46b shall be adopted in 
the form of detailed guidelines.’  

6) 

In Article 51, paragraph 1, the following point (c) is added after point (b): 

in the case of products intended to be placed on the market in the Community, 
‘(c) 
that the safety features referred to in point (o) of Article 54 have been affixed on the 
packaging.’ 

7) 

The following Articles 52a and 52b are inserted after Article 52: 

‘Article 52a 

Importers  and  manufacturers  of  active  substances  used  as  starting  materials 
established in the Community shall notify their address to the competent authority of 
the Member State where they are established. 

Article 52b 

(1)  Notwithstanding  Article  2(1),  and  without  prejudice  to  Title  VII,  Member 
States shall ensure that medicinal products not intended to be placed on the market 
are  not  introduced  into  the  Community  if  there  are  reasons  to  believe  that  the 
products claim a falsified identity, history or source. 

(2)  The Commission shall adopt the necessary measures for the implementation of 
paragraph  1.  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).’ 

8) 

In Article 54, the following point (o) is added: 

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‘(o)  safety  features  making  it  possible  to  ascertain  identification,  authenticity  and 
traceability  of  medicinal  products,  other  than  radiopharmaceuticals,  subject  to 
medical prescription as defined in Title VI.’ 

9) 

The following Article 54a is added: 

‘Article 54a 

(1)  The safety features referred to in point (o) of Article 54 shall allow wholesale 
distributors  or  pharmacists  or  persons  authorised  or  entitled  to  supply  medicinal 
products to the public to perform all of the following: 

(a) 
devices; 

(b) 

(c) 

verify  authenticity  by  assessing  overt,  covert,  or  forensic 

identify individual packs;  

verify whether the outer packaging has been tampered with. 

(2)  The safety features referred to in point (o) of Article 54 shall not be partly or 
fully removed or covered-up, unless the following conditions are fulfilled: 

(a) 
The  manufacturing  authorisation  holder  verifies,  prior  to  partly 
or  fully  removing  or  covering-up  the  safety  feature,  the  authenticity  of 
the product; 

(b) 
The manufacturing authorisation holder complies with point (o) 
of Article 54 by replacing the safety feature with a safety feature which is 
equivalent  as  regards 
identification, 
authenticity and uninterrupted traceability of the medicinal product, and 
without opening the immediate packaging as defined in Article 1(23); 

the  possibility 

to  ascertain 

(c) 
by the competent authority. 

The  replacement  of  the  safety  feature  is  subject  to  supervision 

(3)  Manufacturing authorisation holders shall be liable for damages in accordance 
with Council Directive 85/374/EEC caused by medicinal products which are falsified 
in terms of their identity. 

(4)  The Commission shall adopt the measures necessary for the implementation of 
point (o) of Article 54 and of paragraphs (1) and (2) of this Article. 

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) 

When  adopting  those  measures,  the  Commission  shall  consider  the  risk  related  to 
products or categories of products and at least all of the following: 

(a) 

the price and sales volume of the product; 

EN 

12 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
(b) 

the  number  of  incidences  of  falsifications  in  third  countries  and  within 
the Community; 

(c) 

the evolution of those incidences in the past; 

(d) 

the specific characteristics of the products concerned; 

(e) 

the severity of the conditions intended to be treated. 

On  the  basis  of  these  criteria,  the  requirements  referred  to  in  points  (a)  and  (b)  of 
paragraph  (1)  of  this  Article  may  be  waived  for  certain  products  or  product 
categories. 

The  measures  referred  to  in  this  paragraph  shall  take  due  account  of  the  legitimate 
interests  to  protect  information  of  a  commercially  confidential  nature  and  of  the 
protection of industrial and commercial property rights.’ 

10) 

In Article 57, the fourth indent of the first paragraph is replaced by the following: 

‘- 

without prejudice to point (o) of Article 54, identification and authenticity.’ 

11) 

The heading of title VII is replaced by the following: 

‘Wholesale distribution and trading of medicinal products’; 

12) 

In Article 77, paragraph 4 is replaced by the following: 

‘(4)  The  Member  States  shall  forward  to  the  Agency  a  copy  of  the  authorization 
referred  to  in  paragraph  1.  The  Agency  shall  enter  that  information  in  the 
Community database referred to in Article 111(6). At the request of the Commission 
or  any  Member  State,  Member  States  shall  supply  all  appropriate  information 
concerning the individual authorization which they have granted under paragraph 1.’ 

13)  Article 80 is amended as follows: 

(a)  Point (e) is replaced by the following: 

‘(e) 
they must keep records either in the form of purchase/sales invoices or 
on  computer,  or  in  any  other  form,  giving  for  any  transaction  in  medicinal 
products received, dispatched or traded at least the following information: 

– 

– 

– 

– 

date, 

name of the medicinal product, 

quantity received, supplied or traded, 

name and address of the supplier or consignee, as appropriate;’; 

(b)  The following points (h) and (i) are added: 

‘(h) 

they must maintain a quality system setting out responsibilities, processes 
and risk management; 

EN 

13 

   EN 

 
 
 
 
 
 
(i) 

they must inform the competent authority of products they receive which 
they  identify  as  infringing,  or  they  suspect  of  infringing,  either  of  the 
following: 

– Article 6(1) of this Directive; 

– trademark-holder’s  rights  under  Community  law,  as  provided  for  by 
Council  Regulation  (EC)  No  40/94  of  20  December  1993  on  the 
Community trademark13 or under the law of the Member State where the 
product has been received. 

Moreover, in cases where these infringements or suspected infringements 
relate  to  a  falsified  medicinal  product,  the  holder  of  the  marketing 
authorisation  or  of  the  trademark  that  has  been  falsified  shall  be 
informed.’ 

(c)  The following subparagraphs are added: 

‘For the purpose of  point  (b), in the case where the  product  is obtained 
from another wholesale distributor, holders of the wholesale distribution 
authorisation must verify compliance with good distribution practices of 
the  supplying  wholesale  distributor  either  by  themselves  or  through  a 
body accredited for that purpose by the competent authority of a Member 
State. 

Where the product is obtained from the manufacturer or importer, holders 
of 
the 
the  wholesale  distribution  authorisation  must  verify 
manufacturer or importer holds a manufacturing authorization.’ 

that 

14) 

The following Articles 85a and 85b are inserted after Article 85: 

‘Article 85a 

In  the  case  of  wholesale  distribution  to  third  countries  Article  76,  Article 
80(c) and (i), and Articles 81 and 82 shall not apply. Moreover, Article 80(b) 
shall not apply where a product is directly received from a third country. 

Article 85b 

Persons  trading  medicinal  products  shall  ensure  that  the  traded  medicinal 
products  are  covered  by  a  marketing  authorization  granted  pursuant  to 
Regulation  (EC)  No  726/2004  or  by  the  competent  authorities  of  a  Member 
State in accordance with this Directive. In addition, the requirements set out in 
Article 80(d) to (h) shall apply. 

They shall notify their activity to the competent authority of the Member State 
where they are established.’ 

15)  Article 111 is amended as follows: 

13 

OJ L 11, 14.1.1994, p. 1. 

EN 

14 

   EN 

 
 
 
 
 
 
 
 
 
 
                                                 
(a) 

In paragraph 1, the following subparagraph is added: 

‘Inspections shall be carried out in accordance with the guidelines referred to in 
Article 111a.’ 

(b)  Paragraph 3 is replaced by the following: 

‘(3)  After  every  inspection  as  referred  to  in  paragraph  1,  the  competent 
authority  shall  report  on  whether  the  manufacturer,  importer,  or  wholesale 
distributor complies with the principles and guidelines of good manufacturing 
practice and good distribution practices referred to in Articles 47 and 84 or on 
whether  the  marketing  authorization  holder  complies  with  the  requirements 
laid down in Title IX. 

The  competent  authority  which  carried  out  the  inspection  shall  communicate 
the  content  of  those  reports  to  the  manufacturer,  importer,  marketing 
authorization  holder,  or  to  the  wholesale  distributor  who  has  undergone  the 
inspection. 

Before  adopting 
manufacturer, 
distributor concerned the opportunity to submit their comments.’ 

the 
importer,  marketing  authorization  holder,  or  wholesale 

the  competent  authority  shall  give 

the  report, 

(c)  Paragraphs 5, 6 and 7 are replaced by the following: 

‘(5)  Within  90  days  of  an  inspection  as  referred  to  in  paragraph  1,  a 
certificate of good manufacturing practice or good distribution practice shall be 
issued to the manufacturer, importer, or wholesale distributor if the outcome of 
the  inspection  shows  that  the  person  complies  with  the  principles  and 
guidelines  of  good  manufacturing  practice  or  good  distribution  practice  as 
provided for by Community legislation. 

If  inspections  are  performed  as  part  of  the  certification  procedure  for  the 
monographs of the European Pharmacopoeia, a certificate shall be drawn up. 

(6)  Member  States  shall  enter  the  certificates  of  good  manufacturing 
practice  and  good  distribution  practice  which  they  issue  in  a  Community 
database managed by the Agency on behalf of the Community. 

(7) 
If the outcome of the inspection as referred to in paragraph 1 is that the 
person  does  not  comply  with  the  principles  and  guidelines  of  good 
manufacturing  practices  or  good  distribution  practices  as  provided  for  by 
Community  legislation,  the  information  shall  be  entered  in  the  Community 
database referred to in paragraph 6.’ 

16) 

The following Articles 111a and 111b are inserted after Article 111: 

‘Article 111a 

The  Commission  shall  adopt  detailed  guidelines  laying  down  the  principles  for 
inspections referred to in Article 111.  

EN 

15 

   EN 

 
 
 
 
 
 
 
 
 
 
 
Article 111b 

(1)  The  Commission  shall,  following  a  request  from  a  third  country,  list  that 
country  by  way  of  a  Decision  if  its  regulatory  framework  for  active  substances 
exported  to  the  Community  and  the  respective  control  and  enforcement  ensure  a 
protection  of  public  health  equivalent  to  that  in  the  Community.  Particular  account 
shall be taken of: 

(a) 

the country’s rules for good manufacturing practices; 

(b) 

the regularity of inspections of good manufacturing practices; 

(c) 

the efficacy of enforcement of good manufacturing practices; 

(d) 

the  regularity  and  rapidity  of  information  supplied  by  the  third  country 
relating to non-compliant producers of active ingredients. 

(2)  The  Commission,  in  accordance  with  the  procedure  set  out  in  Article  121(2), 
shall adopt guidelines defining in detail the requirements set out in points (a) to (d) of 
paragraph 1. 

(3)  The Commission, in cooperation with the Agency and competent authorities of 
the Member States, shall verify regularly whether the conditions set out in paragraph 
1  are  fulfilled.  The  first  verification  shall  take  place  no  later  than  3  years  after  the 
country has been listed in accordance with paragraph 1.’ 

17) 

The following Articles 118a, 118b, and 118c are inserted after Article 118: 

‘Article 118a 

The  competent  authorities  shall  issue  the  accreditation  referred  to  in  Articles  46(f) 
and  80(b)  if  the  applicant  can  demonstrate  that  he  is  competent  to  carry  out 
verification  of  compliance  with  good  manufacturing  practices  or,  in  the  case  of 
wholesale distributors, good distribution practices. 

Article 118b 

The Member States shall lay down the rules on penalties applicable to infringements 
of  the  national  provisions  adopted  pursuant  to  this  Directive  and  shall  take  all 
measures necessary to ensure that they are implemented. The penalties provided for 
must  be  effective,  proportionate  and  dissuasive.  The  Member  States  shall  notify 
those  provisions  to  the  Commission  by  [insert  concrete  date  18  months  after 
publication]  at  the  latest  and  shall  notify  it  without  delay  of  any  subsequent 
amendment affecting them. 

Article 118c 

Member  States,  in  applying  this  Directive,  shall  take  the  necessary  measures  to 
ensure  cooperation  between  competent  authorities  for  medicinal  products  and 
customs authorities.’ 

EN 

16 

   EN 

 
 
 
 
 
 
 
 
Article 2 

1) 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions  necessary  to  comply  with  this  Directive  by  [insert  concrete  date  18 
months  after  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. 

They  shall  apply  those  provisions  from  [insert  concrete  date  18  months  after 
publication + one day]. 

However, the Member States shall apply: 

(a) 
the  provisions  necessary  to  comply  with  Article  1(4)  in  so  far  as  it  relates  to 
Articles 46b(2)(b) and 46b(3) of Directive 2001/83/EC as amended by this Directive 
from [insert concrete date 24 months after publication]; 

the  provisions  necessary  to  comply  with  Article  1(6),(8)  and  (9)  from  [insert 

(b) 
concrete date 48 months after publication]. 

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 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

EN 

17 

   EN 

 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  amending 
Directive  2001/83/EC  as  regards  the  prevention  of  the  entry  into  the  legal  supply 
chain of medicinal products which are falsified in relation to their identity, history or 
source 

2. 

ABM / ABB FRAMEWORK 

Policy  Area(s)  concerned  and  associated  Activity/Activities:  Enterprise  –  Internal 
market, product safety 

3. 

BUDGET LINES 

3.1. 

Budget  lines  (operational  lines  and  related  technical  and  administrative 
assistance lines (ex- B..A lines)) including headings: 

02.0302 

3.2. 

Duration of the action and of the financial impact: 

The action will start in 2012 with a duration of 2 years. 

3.3. 

Budgetary characteristics: 

Budget 
line 

Type 
expenditure 

of 

New 

EFTA 
contribution 

Contributions 
from  applicant 
countries 

Heading  in 
financial 
perspective 

02.0302  Non-
comp 

Diff14 

NO 

YES 

NO 

No 1.a 

14 

Differentiated appropriations. 

EN 

18 

   EN 

 
                                                 
4. 

SUMMARY OF RESOURCES 

4.1. 

Financial Resources 

4.1.1. 

Summary of commitment appropriations (CA) and payment appropriations (PA) 

EUR million (to 3 decimal places) 

Year 
2012 

2013 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 

Expenditure type 

Section 
no. 

Operational expenditure15 

Commitment Appropriations 
(CA) 

8.1. 

a 

Appropriations 

Payment 
(PA) 
Administrative expenditure within reference amount16 

b 

Technical  &  administrative 
assistance (NDA) 

8.2.4. 

c 

TOTAL REFERENCE AMOUNT 

Commitment 
Appropriations 

a+c 

Payment Appropriations 
Administrative expenditure not included in reference amount17 

b+c 

Human 
associated 
(NDA) 

resources 

and 
expenditure 

8.2.5. 

d 

8.2.6. 

e 

Administrative  costs,  other 
than  human  resources  and 
associated 
not 
reference 
in 
included 
amount (NDA) 

costs, 

Total indicative financial cost of intervention 

TOTAL CA including cost 
of Human Resources 

TOTAL  PA  including  cost 
of Human Resources 

Co-financing details 

0.25 

0.25 

0.25 

0.25 

a+c
+d+
e 

b+c
+d+
e 

0.5 

0.5 

15 
16 
17 

Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 
Expenditure within article xx 01 04 of Title xx. 
Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

EN 

19 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
If  the  proposal  involves  co-financing  by  Member  States,  or  other  bodies  (please  specify 
which),  an  estimate  of  the  level  of  this  co-financing  should  be  indicated  in  the  table  below 
(additional  lines  may  be  added  if  different  bodies  are  foreseen  for  the  provision  of  the  co-
financing): 

EUR million (to 3 decimal places) 

Co-financing body 

n + 1 

n + 2 

n + 3 

n + 4 

Year 
n 

n  +  5 
and 
later 

Total 

…………………… 

TOTAL  CA  including  co-
financing 

f 

a+c
+d+
e+f 

4.1.2.  Compatibility with Financial Programming 

X 

(cid:133) 

(cid:133) 

Proposal  is  compatible  with  existing  financial  programming  (explanation 
annexed). 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the  financial 
perspective. 

Proposal  may  require  application  of  the  provisions  of  the  Interinstitutional 
Agreement18 (i.e. flexibility instrument or revision of the financial perspective). 

4.1.3.  Financial impact on Revenue 

X 

Proposal has no financial implications on revenue 

(cid:133) 

Proposal has financial impact – the effect on revenue is as follows: 

Budget line 

Revenue 

EUR million (to one decimal place) 

Situation following action 

[Yea
r n] 

[n+1
] 

[n+2
] 

[n+3
] 

[n+4
] 

[n+5
] 

Prior 
to 
action 
[Year 
n-1] 

a)  Revenue 
terms 

in  absolute 

b) Change in revenue 

 ∆ 

4.2. 

Human Resources FTE (including officials, temporary and external staff) – see 
detail under point 8.2.1. 

Annual requirements 

Year n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 

18 

See points 19 and 24 of the Interinstitutional agreement. 

EN 

20 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
later 

Total  number  of  human 
resources 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1. 

Need to be met in the short or long term 

The  EudraGMP  database  shall  be  amended  by  a  chapter  for  persons  introducing 
medicinal products and by a chapter on wholesale distributors. 

This is a relatively simple IT-task, as the actual database (listing all manufactuerers 
and importers) is already available. It is therefore merely an extension of the existing 
database to more actors handling medicinal products. 

5.2. 

Value-added  of  Community  involvement  and  coherence  of  the  proposal  with 
other financial instruments and possible synergy 

Value  added  is  a  facilitated  inspection  of  wholesale  distributors  and  of  persons 
introducing  medicinal  products.  This  helps  to  ensure  thorough  enforcement  of  the 
respective requirements for these actors in the EU. 

5.3. 

Objectives, expected results and related indicators of the proposal in the context 
of the ABM framework 

To  add  to  the  existing  database  for  manufacturers  and  importers  of  medicinal 
products an additional chapter on introduction and wholesale distribution. 

5.4.  Method of Implementation (indicative) 

Show below the method(s) chosen for the implementation of the action. 

(cid:133) 

X 

(cid:133) 

(cid:133)  Centralised Management 

(cid:133) 

(cid:133) 

directly by the Commission 

indirectly by delegation to: EMEA 

executive Agencies 

bodies set up by the Communities as referred to in art. 185 of the Financial Regulation 

national public-sector bodies/bodies with public-service mission 

(cid:133) 

Shared or decentralised management 

(cid:133)  with Member states 

(cid:133)  with Third countries 

(cid:133) 

Joint management with international organisations (please specify) 

EN 

21 

   EN 

 
 
 
 
 
 
 
Relevant comments: 

6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

The effectiveness of the database can be monitored by assessing its usability. There 
are  various  working  groups  which  would  assess  this  effectiveness,  such  as  the 
working group of enforcement officers. 

6.2. 

Evaluation 

6.2.1.  Ex-ante evaluation 

An ex-ante evaluation, assessing impacts of this measures and possible alternatives is 
contained  in  the  impact  assessment  submitted  together  with  the  Commission 
proposal  in  Inter-Service  Consultation.  The  impact  assessment  concludes  that 
transparency  of  results  of  inspections  contributes  to  efficient  surveillance  by 
competent authorities in the Member States as well as to the reliability of commercial 
actors. 

The impact assessment board supported the impact assessment. The final opinion is 
available here: http://ec.europa.eu/governance/impact/cia_2008_en.htm. 

6.2.2.  Measures  taken  following  an  intermediate/ex-post  evaluation  (lessons  learned  from 

similar experiences in the past) 

6.2.3.  Terms and frequency of future evaluation 

Ongoing in view of the continuous use of the electronic portal by the economic actors. 

7. 

8. 

ANTI-FRAUD MEASURES  

DETAILS OF RESOURCES 

8.1. 

Objectives of the proposal in terms of their financial cost 

N/A 

8.2. 

Administrative Expenditure 

8.2.1.  Number and type of human resources 

N/A 

8.2.2.  Description of tasks deriving from the action 

Initiating  work  on  an  extension  of  the  existing  database  to  wholesaler  distributors 
and persons introducing medicinal products 

EN 

22 

   EN 

 
8.2.3. 

Sources of human resources (statutory) 

When  more  than  one  source  is  stated,  please  indicate  the  number  of  posts  originating  from 
each of the sources 

(cid:133) 

(cid:133) 

(cid:133) 

(cid:133) 

(cid:133) 

Posts currently allocated to the management of the programme to be replaced 
or extended 

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

Posts  to  be  redeployed  using  existing  resources  within  the  managing  service 
(internal redeployment) 

Posts required for year n although not foreseen in the APS/PDB exercise of the 
year in question 

EN 

23 

   EN 

 
8.2.4.  Other  Administrative  expenditure  included  in  reference  amount  (XX  01  04/05  – 

Expenditure on administrative management) 

Budget line 

(number and heading) 

EUR million (to 3 decimal places) 

Year 
2012 

Year 
2013 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5  

TOTAL 

and 
later 

Technical 

1 
and 
assistance (including related staff costs) 

administrative 

Executive agencies19 

Other 

technical 

and 

administrative 

assistance 

- intra muros  

- extra muros 

Total  Technical  and  administrative 
assistance 

8.2.5.  Financial cost of human resources and associated costs not included in the reference 

amount 

EUR million (to 3 decimal places) 

Type of human resources 

Year n 

Year n+1  Year n+2  Year n+3  Year n+4  Year n+5 

and later 

Officials  and  temporary  staff 
(XX 01 01) 

Staff  financed  by  Art  XX  01 
02  (auxiliary,  END,  contract 
staff, etc.) 

(specify budget line) 

cost 

Total 
of  Human 
Resources  and  associated 
costs 
in  reference 
amount) 

(NOT 

Calculation– Officials and Temporary agents 

19 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

EN 

24 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Reference should be made to Point 8.2.1, if applicable 

… 

Calculation– Staff financed under art. XX 01 02 

Reference should be made to Point 8.2.1, if applicable 

… 

8.2.6. Other administrative expenditure not included in reference amount 

EUR million (to 3 decimal places)

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 

TOTAL 

and 
later 

XX 01 02 11 01 – Missions 

XX 01 02 11 02 – Meetings & Conferences 

XX 01 02 11 03 – Committees20  

XX 01 02 11 04 – Studies & consultations 

XX 01 02 11 05 - Information systems 

2 

Total 

Other  Management 

Expenditure (XX 01 02 11) 

3  Other 

expenditure 

administrative 
including reference to budget line) 

nature 

of 

an 
(specify 

expenditure, 
than  human  resources  and 
in 

Total  Administrative 
other 
associated  costs  (NOT 
reference amount) 

included 

Calculation - Other administrative expenditure not included in reference amount 

… 

Annex 

20 

Specify the type of committee and the group to which it belongs. 

EN 

25 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
The  Legislative  Financial  Statement  is  based  on  the  fact  that  the  legislative  proposal,  if 
adopted,  will  require  the  European  Medicines  Agency  (“EMEA”)  to  adapt  the  IT 
arrangements  of  the  present  EudraGMP  database  to  include  other  actors  in  the  distribution 
chain, in particular wholesale distributors. 

This measure is not expected to have an additional financial impact on the Community budget 
for the following reasons: 

(cid:121) 

(cid:121) 

(cid:121) 

a) 

b) 

c) 

Year 

The  costs  of  the  measure  are  with  500 000 EUR  over  two  years  relatively  modest 
(below, a); 

The EMEA has had, in recent years, a high budget surplus (below, b); and 

There  is  a  possibility  for  EMEA  to  re-programme  its  telematics  budget  for  the 
expected entry into force date of 2012 (below, c). 

At  the  outset,  it  has  to  be  highlighted  that  the  costs  for  the  measure  are  relatively 
minor. They amount to 500 000 EUR over a period of 2 years (2012 and 2013). This 
is a conservative estimation of the costs. As the measure concerns in practice a mere 
adaptation  of  the  IT  system  to  an  extended  scope  of  the  existing  EudraGMP 
database, the costs may even be lower. 

The  EMEA  budget  was  €163  million  in   2007.  The  Community  contribution  has 
increased from €15.3 million in 2000 to €41 million in 2007. The remainder of the 
increase  of  the  budget  over  time  has  been  covered  by  fees  charged  by  the  EMEA 
(estimated at 77% of total income in 2008 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  in  line  with  the 
general  increase  in  the  number  of  centrally  authorised  products.  It  should  be  noted 
that, based on fee income, the EMEA budget has run at a surplus in recent years and 
use has been made of the carry-over facility. Indeed, in 2006 the surplus was superior 
to €8 million. 

The current EMEA programming for telematics "development costs" (as included in 
the EMEA Telematics Master Plan) provides for the following budget:  

2008 

2009 

2010 

2011 

2012 

2013 

Total 
for 
period 

12.6 

11.9 

13.1 

13.1 

12.8 

10.4 

74.1 

Total  IT  annual  budget 
(m EUR  to  one  decimal 
place 

As  set  out  above,  extending  the  EudraGMP  database  is  likely  to  incur  costs  of 
maximal 500 000 EUR over 2 years. These costs are going to emerge in 2012 for the 
database to be live once the proposal is adopted, transposed, and applied thereafter. 

It is therefore reasonable to require the EMEA to re-programme these one-off costs 
from its existing telematics budget. 

EN 

26 

   EN