REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on trends in the falsification of medicinal products and measures provided according to Directive 2011/62/EU as required in Article 3 thereof
Date: 2024-07-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU trade mark, consumer protection, distributive trades, electronic commerce, falsified medicine, illicit trade, industrial counterfeiting

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 4.7.2024  COM(2024) 274 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on trends in the falsification of medicinal products and measures provided according to Directive 2011/62/EU as required in Article 3 thereof  
 
 
CONTENTS 

1.  Executive summary ..................................................................................................... 2 

2. 

Introduction and legal framework ............................................................................... 4 

3.  Trends in the falsification of medicinal products ........................................................ 5 

3.1.  Quantitative data on falsified medicinal products ............................................. 5 
3.2.  Categories of medicinal products affected ........................................................ 6 
3.3.  Member  States  concerned,  regions  of  provenance,  and  distribution 

channels ............................................................................................................. 6 
3.4.  Conclusions ....................................................................................................... 7 

4.  Contribution made by the measures that aim to prevent the entry of falsified 

medicinal products into the legal supply chain ........................................................... 7 

4.1.  Governance of the repositories system .............................................................. 8 
4.2.  Scope ................................................................................................................. 8 
4.3.  Unique identifier and anti-tampering device ..................................................... 9 
4.4.  Verification mechanism ..................................................................................... 9 
4.5.  Reporting mechanism ...................................................................................... 11 
4.6.  Perceptions held by both stakeholders and NCAs ........................................... 12 
4.7.  Conclusions ..................................................................................................... 12 

5.  Overall conclusions and next steps............................................................................ 13 

 
 
 
 
1.  EXECUTIVE SUMMARY 

In  June  2011,  the  European  Parliament  and  the  Council  adopted  Directive  2011/62/EU  (1), 
also  known  as  the  Falsified  Medicines  Directive.  The  Directive  had  two  purposes:  (i)  to 
address an increase in the number of falsified medicinal products detected in the EU; and (ii) 
to  strengthen  the  supervision  of  the  legal  supply  chain  for  medicines  for  human  use.  The 
Directive introduced harmonised European rules to ensure that falsified medicinal products do 
not  enter  the  legal  supply  chain  of  the  single  market  and  reach  patients.  It  stipulates  that 
medicinal  products  for  human  use  subject  to  prescription  must  bear  safety  features  on  their 
packaging.  

Detailed rules for these safety features are laid down by Delegated Regulation (EU) 2016/161 
(2).  The  Delegated  Regulation  became  applicable  in  2019  and  introduced  verification 
mechanisms  and  obligatory  safety  features  for  medicinal  products.  These  verification 
mechanisms and safety features are: 

1. 

2. 

a unique identifier (a 2-dimensional bar code), the authenticity of which proves the 
legitimacy of an individual pack of a medicinal product; 
an  anti-tampering  device,  the  integrity  of  which  demonstrates  the  authenticity  of 
the medicinal product in its packaging. 

Article  3  of  Directive  2011/62/EU  requires  the  Commission  to  present  a  report  to  the 
European Parliament and to the Council at the latest five years after the date of application of 
the Regulation. The report must contain: (i) a description of recent trends in the falsification 
of  medicinal  products;  and  (ii)  an  assessment  of  the  contribution  made  by  the  measures 
provided for in this Directive to preventing the entry of falsified medicinal products into the 
legal supply chain.  

The  present  report  delivers  on  this  obligation.  It  is  based  on  the  findings  of  the  Study 
supporting  the  report  to  the  European  Parliament  and  to  the  Council  on  trends  in  the 
falsification of medicinal products and measures provided according to Directive 2011/62/EU 
written by an external consultant in 2023. The Study examined the effects of the measures laid 
down by the Falsified Medicines Directive and the Delegated Regulation in the EU and EEA. 
It is published on the Commission’s homepage3. 

For the reasons set out below, it is not yet possible to draw final conclusions as to the effects 
of  the  Directive  and  the  Delegated  Regulation.  Nevertheless,  it  is  safe  to  say  that,  overall, 

(1)  Directive 2011/62/EU of the European Parliament and of the  Council of 8 June 2011 amending  Directive 
2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention 
of the entry into the legal supply chain of falsified medicinal products OJ L 174, 1.7.2011, pp. 74-87. 

(2)   Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC 
of  the  European  Parliament  and  of  the  Council  by  laying  down  detailed  rules  for  the  safety  features 
appearing on the packaging of medicinal products for human use OJ L 32, 9.2.2016, pp. 1–27. 

(3)  see at: https://health.ec.europa.eu/publications/study-supporting-report-european-

parliament-and-council-trends-falsification-medicinal-products-and_en 

2 

 
 
substantial  and steady progress  in  detecting  falsified medicines has been  observed since the 
Directive  and  the  Delegated  Regulation  came  into  application.  Most  cases  of  falsification 
have been detected in the illegal supply chain (often via unauthorised sales on the internet). 
Even on the few occasions that falsified medicinal products were identified in the legal supply 
chain,  the  national  authorities,  in  collaboration  with  the  supply-chain  operators,  promptly 
addressed  the  matter.  Medicinal  products  that  are  purchased  in  the  official  channels,  i.e. 
physical or online authorised pharmacies, can be assumed to be safe. 

The Falsified Medicines Directive and the Delegated Regulation increase the hurdles and the 
cost of falsification for criminals. They also make it possible to generate data that can help to 
swiftly detect and investigate suspicious packages and track falsifying activities.  

However,  it  is  not  yet  possible  to  assess in  detail  the  effect  that  the  measures  set  out  in  the 
Delegated Regulation have had because they are not yet completely implemented. There are 
five  main  reasons  for  this  incomplete  implementation:  (i)  many  pharmacies  are  still  not 
connected to the EU system; (ii) some of the pharmacies that are connected to the system may 
not yet be using the IT system effectively; (iii) some IT systems developed at national level 
still  trigger  a  level  of  false  alerts  that  is  too  high;  (iv)  the  governance  of  the  system  by  the 
responsible  organisations  representing  supply-chain  operators  has  sometimes  led  to  internal 
conflicts on the use of the information contained in the EMVS; and (v) the lack of standard 
procedures to qualify cases as confirmed cases of falsification and the lack of centralised files 
reporting  all  cases  across  the  EU/EEA  make  comparisons  and  trend  analysis  particularly 
difficult.  

Furthermore, the legislation granted Belgium, Greece and Italy an extended transition period 
to  adapt  their existing  system to  the EU rules.  Belgium  voluntarily applies the rules  as of 9 
February 2019. Greece and Italy are only due to join the EU system in 2025. Therefore, a full 
assessment  of  the  impact  of  the  Falsified  Medicines  Directive  and  Delegated  Regulation  is 
currently not possible.  

Over  the  past  years,  the  Commission  has  continuously  engaged  with  national  competent 
authorities (NCAs) and stakeholders to ensure progress towards full implementation, and it is 
committed to continue to do so. 

3 

 
 
 
 
2. 

INTRODUCTION AND LEGAL FRAMEWORK 

In  June  2011,  the  European  Parliament  and  the  Council  adopted  Directive  2011/62/EU  (4), 
also  known  as  the  Falsified  Medicines  Directive,  to  strengthen  the  supervision  of  the  legal 
supply chain for medicines for human use.  

Delegated Regulation (EU) 2016/161 (5), laying down the detailed rules for the safety features 
appearing on the packaging of medicinal products for human use, complements the Directive. 
The safety features link to a data repository governed by non-profit organisations representing 
the  supply-chain  operators  (6).  The  Delegated  Regulation  has  been  in  application  since  9 
February 2019 and covers prescription medicines, although its scope can be extended to non-
prescription medicinal products at risk of falsification.  

Greece and Italy still use an extended transition period granted to Member States that already 
had a system in place. They are obliged to join the EU system by February 2025. 

The verification operates as an end-to-end system. Safety features are placed on the medicinal 
products at the manufacturing stage and must be verified at the end of the supply chain upon 
decommissioning  of  the  medicine  packs.  Additional  verifications  are  required  along  the 
supply chain when a risk of introduction of a falsified medicine is deemed significant. 

Article 3 of the Falsified Medicines Directive requires that the Commission presents a report 
to the European Parliament and to the Council on the following: 

a)  a  description,  where  possible  including  quantitative  data,  of  the  trends  in  the 
falsification  of  medicinal  products  in  terms  of  categories  of  medicinal  products 
affected, distribution channels including sale at a distance to the public by means of 
information  society  services,  the  Member  States  concerned,  the  nature  of  the 
falsifications, and the regions of provenance of these products; and  

b)  an  evaluation  of  the  contribution  of  the  measures  provided  for  in  this  Directive 
regarding  the  prevention  of  the  entry  of  falsified  medicinal  products  in  the  legal 
supply  chain.  That  evaluation  shall  in  particular  assess  point  (o)  of  Article  54  and 
Article 54a of Directive 2001/83/EC as inserted by this Directive. 

The  Commission  asked  an  external  consultant  to  conduct  a  study  (‘the  Study’)  on  the  two 
subjects cited under (a) and (b) above from the perspective of: (i) the parties involved in the 
supply  chain;  and  (ii)  the  Member  States’  enforcement  authorities.  The  resulting  Study 
supporting  the  report  to  the  European  Parliament  and  to  the  Council  on  trends  in  the 

(4)  Directive 2011/62/EU of the European Parliament and of the  Council of 8 June 2011 amending Directive 
2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention 
of the entry into the legal supply chain of falsified medicinal products OJ L 174, 1.7.2011, pp. 74-87. 

(5)  Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC 
of  the  European  Parliament  and  of  the  Council  by  laying  down  detailed  rules  for  the  safety  features 
appearing on the packaging of medicinal products for human use. OJ L 32, 9.2.2016, pp. 1-27. 

(6)    Manufacturers,  marketing  authorisation  holders,  wholesalers  and  persons  authorised  or  entitled  to  supply 

medicinal products to the public. 

4 

 
 
falsification of medicinal products and measures provided according to Directive 2011/62/EU 
is the basis for the present report. 

3.  TRENDS IN THE FALSIFICATION OF MEDICINAL PRODUCTS  

This section addresses point (a) of Article 3 of Directive 2011/62/EU. 

3.1.  Quantitative data on falsified medicinal products 

The Falsified Medicines Directive amended Directive 2001/83/EC, i.e. the Community code 
relating to medicinal products for human use, and defines a ‘falsified medicinal product’ as: 

Any medicinal product that has a false representation of: (a) its identity, including its 
packaging  and  labelling,  its  name  and  its  composition,  (b)  its  source,  including  its 
manufacturer,  its  country  of  manufacturing,  its  country  of  origin  or  its  marketing 
authorisation holder, or (c) its history, including the records and documents relating to 
the distribution channels used. 

This  definition  distinguishes  ‘falsified  medicinal  products’  from  ‘counterfeit  medicinal 
products’.  The  latter  infringe  intellectual  property  rights  or  trademark  law.  Statistics  on 
counterfeit  medicinal  products  are  often  used  as  a  proxy  to  estimate  trends  in  falsified 
medicinal products, but falsified medicines are not necessarily counterfeit. 

Neither the European Medicines Agency (EMA) nor the NCAs consistently monitored cases 
of  falsification  before  the  adoption  of  the  Delegated  Regulation.  The  EMA  did  not  keep 
distinct  records  for  falsified  medicines  and  other  issues  involving  medicines  in  the  supply 
chain, such as thefts. As a result, it is difficult to assess how the situation has evolved. 

Since the adoption of the  Delegated Regulation,  the EMA has  recorded  and coordinated the 
exchange of information on falsified medicine notifications for centrally authorised medicines 
(7). According to  the EMA,  30 potential cases  of  falsification  were  detected in  the EU/EEA 
between  2011  and  2016  included,  and  there  have  been  11  confirmed  cases  of  falsified 
medicines since 2019.  

Member  States  are  responsible  for  supervising  and  investigating  the  supply  chain,  and 
deciding  on  measures  to  be  taken  in  the  event  of  suspected  and  confirmed  cases  of 
falsification for nationally authorised medicines. In addition, when a suspected case is notified 
to the EMA it must be further investigated by Member States. 

The diversity of measures and approaches implemented by Member States, including in terms 
of classification into suspected and confirmed cases, as described in detail in the Study, makes 
it  impossible  to  draw  clear  conclusions  as  to  trends.  Cases  from  different  Member  States 
cannot be easily aggregated for the purpose of an overall analysis.  

It  is  also  possible  that  some  cases  of  falsification  are  undetected.  This  is  due  to:  (i)  the 
protracted  implementation  of  the  Delegated  Regulation  (the  so-called  stabilisation  period 

(7)  EMA  webpage  on  falsified  medicines.  https://www.ema.europa.eu/en/human-regulatory-overview/post-

authorisation/compliance-post-authorisation/falsified-medicines-reporting-obligations. 

5 

 
 
further described below); and (ii) the slow process for connecting operators to the system. The 
number of cases reported does not therefore necessarily reflect adequately the actual trend of 
falsified medicinal products on the market. This is further described in the second part of the 
Study. 

In  summary,  the  differences  between  national  processes  and  the  lack  of  centralised  data  are 
factors  that  make  it  impossible  to  provide  reliable  quantitative  data  on  trends  in  the 
falsification  of  medicinal  products.  Complete  implementation  and  a  standardised  reporting 
system would allow to draw conclusions as to the quantification of suspected and confirmed 
cases of falsified medicinal products. 

3.2.  Categories of medicinal products affected 

According to  the NCAs, the categories of medicinal  products  most likely  to  be falsified are 
expensive  medicines  such  as  anti-cancer  injections  (8)  and  ‘lifestyle  drugs’  such  as  muscle-
building  steroids  and  sexual  enhancers.  These  products  promise  the  largest  revenues  for 
falsifiers and are widely purchased online. 

3.3.  Member States concerned, regions of provenance, and distribution channels 

The pharmaceutical supply chain often crosses borders between EU countries. Consequently, 
all countries are at risk of having falsified medicinal products on their market.  

The Falsified Medicines Directive is intended to protect those purchasing medicinal products 
through legal means (in authorised stores and online pharmacies).  

According to the Study, most cases of falsifications have been detected in the  illegal supply 
chain.  Illegal  supply  chains  differ  from  legal  ones  as  they  operate  deliberately  outside  the 
applicable laws. It is possible that medicines available in the legal supply chain are diverted to 
illegal networks of distribution. 

The Study gives the example of a colon-cancer medicine stolen from hospitals, manipulated, 
and re-introduced into the legal supply chain under false credentials, and then  distributed by 
wholesalers  (9).  Similar  observations  were  made  in  the  EU-funded  project  MEDI-THEFT 
launched in November 2021  (10). The existence of unauthorised online traders increases  the 
availability  of  falsified  medicines.  Authorities  have  difficulties  in  effectively  monitoring 
online sales as online sales are typically for small shipments that are not detected by existing 
enforcement mechanisms.  

(8)   Data  submitted  by  NCAs  show  that  there  can  be  as  many  as  several  thousand  prescribed  anti-cancer 
medicinal  products  which  are  priced  per  dose  depending  on  the  country.  These  prescribed  anti-cancer 
medicinal products are particularly targeted by falsifiers.  

(9)  Both  authorised  and  non-authorised  wholesalers  were  involved.  For  more  details,  see  the  case  studies 

presented in the Study related to this subject matter. 

(10)  Medi-Theft at https://www.transcrime.it/en/projects/medi-theft/. 

6 

 
 
 
 
Given  the  differences  in  reporting  between  Member  States,  the  Study  could  not  identify 
specific regions of provenance or distribution for falsified medicines.  

The rise of online sales has increased the risk of illegal traders entering the supply chain. Only 
legal  online  pharmacies  displaying  the  common  logo  (11)  participate  in  the  EU  medicines 
authentication system set up under the Falsified Medicines Directive and are a reliable source 
of  supply.  The  logo  allows  the  public  to  clearly  distinguish  a  legal  website  from  an  illegal 
website. 

3.4.  Conclusions  

Based  on  the  information  made  available  by  the  Study,  the  Commission  considers  it 
impossible at this stage to draw clear conclusions as to trends in the falsification of medicinal 
products.  

It is only possible to make the following three broad points.  

•  The  categories  of  medicinal  products  that  are  most  often  subject  to  falsification  are 
expensive  prescription  medicines  and  products  in  high  demand  such  as  ‘lifestyle 
drugs’. These are in particular sold outside the legal supply chain via non-authorised 
websites. 

•  The widespread access to online sales increases the risk that falsified medicines could 
be distributed through illegal suppliers. There is the need to unlock the full potential of 
the  common  EU  logo  to  protect  consumers  and  patients  from  falsified  medicinal 
products available on online markets. 

•  The  Study  could  not  identify  specific  regions  of  provenance  or  distribution  for 

falsified medicines.  

4.  CONTRIBUTION  MADE  BY  THE  MEASURES  THAT  AIM  TO  PREVENT  THE  ENTRY  OF 

FALSIFIED MEDICINAL PRODUCTS INTO THE LEGAL SUPPLY CHAIN  

This  section  addresses  point  (b)  of  Article  3  of  the  Falsified  Medicines  Directive,  i.e. 
assessing  the  contribution  of  the  measures  set  out  in  the  Directive  on  falsified  medicinal 
products  in  the  legal  supply  chain.  This  section  analyses  the  functioning  of  the  measures 
provided for in both the Falsified Medicines Directive and the Delegated Regulation, i.e. the 
implementation  of  point  (o)  of  Article  54  and  Article  54(a)  of  the  amended  Directive 
2001/83/EC outlining the scope and the measures introduced.  

The measures: (i) lay down concrete mechanisms to prevent falsified medicines from entering 
the legal supply chain; (ii) set out arrangements for the governance of the repositories system; 
(iii) describe the safety features to be used (unique identifier, anti-tampering device); (iv) set 
out the verification activities; and (v) set out how to report falsified medicinal products.  

(11) The common logo for legally operating online pharmacies/retailers in EU countries was first introduced by 
Directive  2011/62/EU  as  one  of  the  measures  to  fight  against  falsified  medicines.  In  2014,  the  European 
Commission adopted the new common logo through Implementing Regulation 699/2014. 

7 

 
 
 
 
 
4.1.  Governance of the repositories system 

The  Delegated  Regulation  lays  down  a  stakeholder-led  governance  model  allowing  supply-
chain operators to organise themselves. Non-profit legal entities representing the operators in 
the  supply  chain  manage  the  system.  At  EU  level,  the  European  Medicines  Verification 
Organisation  (EMVO)  is  responsible  for  setting  up  and  managing  the  European  Medicines 
Verification System (EMVS). At national level, national medicines verification organisations 
(NMVOs)  implement  and  manage  the  verification  systems  connected  to  the  EMVS.  In  this 
two-tier  architecture,  national  data  are  stored  and  managed  nationally,  but  transfer  of 
information across borders is possible. Marketing authorisation holders bear the costs of the 
system.  All  operators  engaged  in  the  supply  chain  participate  via  their  representative 
associations  at  EU  and  national  levels.  Software  providers  run  the  information  technology 
system  under  service  contracts  (two  providers  govern  the  EMVS).  These  contracts  do  not 
guarantee swift adaptation of software.  

The nature of the commercial and contractual relations with the software providers has led to 
delays in the development and rolling out of the IT tools.  

Every EU/EEA Member State has an NMVO in place. The only exceptions are Belgium and 
Luxembourg, as both use the Belgian Medicines Verification System. 

NCAs supervise the functioning of the NMVOs and have access to reports from the repository 
system to track suspicious packages or behaviours. Such investigations can be complicated by 
the two-tier architecture as a full ‘audit trail’ (i.e. the ability to trace back the supply chains, 
sources and origins  of the falsification of  a product  beyond the national  territory of a given 
country) is in  practice not  immediately  available to  NCAs, even though  this  is  stipulated in 
the Delegated Regulation (Article 35(1)(g)). 

The  two-tier  architecture  is  also  due  to  the  specificity  of  this  stakeholder-led  governance 
model.  It  creates  challenges  in  finding  common  approaches,  as  there  can  be  significant 
divergence  in  the  positions  of  stakeholders  represented  on  the  management  boards  of  the 
organisations  in  charge  at  EU  and  national  levels  impacting  their  ability  to  take  strategic 
decisions. 

4.2. 

Scope 

The  scope  of  the  Delegated  Regulation  covers  prescription  medicines  and  non-prescription 
medicines  identified  to  be  at  a  high-risk  of  falsification.  However,  the  legislation  allows 
Member  States  to  extend  the  scope  to  address  national  needs.  For  example,  some  Member 
States  require  an  anti-tampering  device  to  also  be  placed  on  non-prescription  medicines 
(‘over-the-counter’ products). 

The  primary  objective  of  the  Falsified  Medicines  Directive  and  Delegated  Regulation  is  to 
prevent falsified medicinal products from entering the legal supply chain. In addition, and in 
line  with  the  legislation,  several  Member  States  also  use  the  safety  features  for  purposes 

8 

 
 
 
related  to  pharmacovigilance,  pharmacoepidemiology  and  reimbursement.  Figure  1  outlines 
the replies received from NCAs about what they used the repositories system for. 

Figure 1. Use of the repositories system by the NCAs 

BE  BG  CY  CZ  EE 
X 
X 
X 

X 
X 
X 

X 
X 

X 

FI 

FR  DE  HU 

X  X  X 

X 

X 

Supervising 
Investigating 
Reimbursement 
Pharmacovi-
gilance or 
pharmacoepi-
demiology 
Source: Survey to NCAs 

X 

IE 
X  X 
X  X 

LT  MT  NL 
X 
X 

X 

PL 
X 
X 

PT 
X 
X 
X 

SK 

X 

SL  ES 
X 
X 
X 
X 
X 

SE 
X 
X 

X 

X 

The current  scope, with  its flexibility,  correctly reflects  the objective of  minimising the risk 
brought  by  falsified  medicines.  It  appropriately  balances  the  risks  posed  by  falsified 
medicines with the administrative burden involved in preventing these risks. 

4.3.  Unique identifier and anti-tampering device  

The technical specifications of the unique identifier (UI) make it possible to securely identify 
legitimate  medicinal  products.  They  also  harmonise  the  product  coding  system.  The  Study 
showed that most of the stakeholders and all NCAs that replied consider the UI adequate. 

The purpose of the anti-tampering device (ATD) is to guarantee that medicinal packs are not 
opened  or  otherwise  altered  before  dispensing.  It  has  become  apparent  that  the  absence  of 
precise  requirements  for  the  design  of  the  ATD  and  for  its  verification  can  reduce  the 
effectiveness of this safety measure. Even though  there are no mandatory specifications, the 
document  ISO 21976:2020  ‘Packaging  – Tamper verification features for medicinal product 
packaging’ is  available for manufacturers to  consider. This  document specifies requirements 
and provides guidance for the  application, use, and checking of tamper-verification  features 
on the packaging of medicinal products. 

4.4.  Verification mechanism 

As indicated in paragraph 4.1 on the governance of the repositories system, the EMVS builds 
on a two-tier architecture. National repositories (NMVOs) are linked to a central hub which is 
managed  by  the  EMVO.  NCAs  and  stakeholders  in  all  Member  States  confirm  the 
functionality and appropriateness of this architecture.  

The  Commission  has  continuously  engaged  with  national  authorities  and  stakeholders. 
Consequently,  combined  with  the  support  provided  by  EMVO,  the  number  of  users  and 
medicinal  products  registered  in  the  EMVS  continues  to  grow,  especially  for  community 
pharmacies. Figure 2 and Figure 3 illustrate the number of stakeholders connected to the EU 
system in March 2024 and in January 2023 (excluding Italy and Greece). 

Figure 2. Stakeholder connection overview as of calendar week 9, 2024  

9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
End-User Type 

Wholesalers 
Pharmacies 
Healthcare Institutions 
Dispensing Doctors 
Other Decomm. Channels 
Source: EMVO report, March 2024 

Not Connected 
1 
6 
760 
58 
60 

Connected 
4113 
116 311 
6451 
817 
381 

Percentage Remaining 
0.023% 
0.013% 
10.543% 
6.633% 
13.613% 

Figure 3. Stakeholder connection overview as of calendar week 52, 2022 

End-User Type 

Wholesalers 
Pharmacies 
Healthcare Institutions 
Dispensing Doctors 
Other Decomm. Channels 
Source: EMVO report, January 2023 

Not Connected 
13 
3967 
1049 
56 
60 

Connected 
4074 
113 639 
6374 
819 
436 

Percentage Remaining 
0.323% 
3.373% 
14.133% 
6.403% 
12.103% 

However,  many  operators  that  are  currently  connected  to  the  EMVS  are  still  not  yet  fully 
using  the  system  effectively. According  to  EMVO  data  from  September  2023,  26%  of  the 
medicines with safety features are not checked out of the repository system when  dispensed 
(‘decommissioned’),  putting  them  in  breach  of  the  EU  legislation (12).  Two  main  problems 
with the EMVS are set out in the bullet points below.  

•  Some  pharmacists  admit  that  they  do  not  decommission  medicinal  products  when 
dispensing them to patients. They argue that verification, i.e. scanning the UI, triggers 
high numbers of alerts for medicinal products that could possibly be false alerts. This 
causes delays, interrupts workflows, and fuels patient dissatisfaction. 

•  Single-pack verification is considered an excessive burden in hospital pharmacies due 
to  the  large  number  of  products  handled  in  this  setting.  Verification  is  time-
consuming.  The  Member  State  Expert  Group  on  safety  features  issued  a  working 
paper  in  2018  in  which  it  proposes  bulk  verification  using  ‘aggregated  codes’  or 
‘consolidated  codes’.  The  use  of  these  codes  allows  a  speedier  and  more  efficient 
process of decommissioning of packages of the same content and origin. 

The  system  was  designed  to  prevent  falsified  medicinal  products  from  reaching  patients. 
Wholesalers can verify the packs at their disposal if they have suspicions. Wholesalers are not 
obliged to verify all packs systematically (i.e. those received from the marketing authorisation 
holder, manufacturer or a designated wholesaler do not need to be verified). This is to avoid a 
disproportionate burden for wholesalers. 

Based on these considerations, it is not possible at this stage to draw clear conclusions on the 
actual ability of the EMVS to effectively detect all falsified medicinal products throughout the 

(12)  ‘Decommissioning  of  a  unique  identifier’  means  the  operation  changing  the  active  status  of  a  unique 
identifier stored in the repositories system referred to in Article 31 of the  Delegated Regulation to a status 
preventing any further successful verification of the authenticity of that unique identifier. 

10 

 
 
supply chain. However, evidence shows that the few cases of falsification in the legal supply 
chain were promptly addressed when they were detected.  

4.5.  Reporting mechanism 

The  reporting  system  is  based  on  two  alert  mechanisms  for  falsified  medicinal  products, 
described in the two paragraphs below.  

1.  EMVS automated code-scanning alerts: the objective agreed in the EMVO is to reach 
an alert rate of less than 0.05%. According to the EMVO’s report of March 2024, in 
seven  countries  (including  Northern  Ireland (13),  the  alert  rate  is  between  0.16%  and 
1.17% (Lichtenstein). According to the EMVO, the three main causes of this are: (i) 
mistakes in the data uploaded by the marketing authorisation holder to the European 
hub;  (ii)  scanner  issues;  and  (iii)  double  decommissioning.  This  is  however  a 
noticeable improvement compared to the initial phase of the implementation. 

2.  User notifications of suspicious packages: a lack of clarity in Articles 18, 24 and 30 of 
the  Delegated  Regulation  on  terms  and  responsibilities  result  in  little  use  of  this 
option.  

Many  automated  alerts  are  not  subsequently  confirmed  in  the  form  of  falsified  medicinal 
products. To avoid a situation in which many products are not provided to patients because of 
technical issues creating false alerts, the EMVO promoted a ‘stabilisation period’ at the start if 
the system which was extended several times.  

During  these  stabilisation  periods,  even  if  a  product  raised  an  alert,  the  persons 
authorised/entitled to supply medicinal products to the public could  dispense that product to 
patients upon careful control of the packaging. It was introduced to  avoid disruptions in the 
supply chain due to alerts caused by missing or incorrectly uploaded data, scanning products 
not in the scope of FMD, procedural mistakes etc.  

Based  on  EMVO’s  monitoring  report  of  March  2024,  six  Member  States  still  allow  to 
dispense medicine packs that raise alerts in the system. As a result, some Member States (14) 
set up parallel national alert-management systems. 

NMVOs systematically investigate alerts emanating from automated code scanning with the 
support of the NCAs. The follow-up on these alerts as suspected and/or confirmed cases, does 
not  follow  the  same  procedures  in  each  Member  State.  Moreover,  users  rarely  notify 
suspicious packages on their own initiative. 

(13)  Which  in  the  meantime  left  the  system  with  the  Windsor  Framework,  Joint  Declaration  No 1/2023  of  the 
Union and the United Kingdom in the Joint Committee established by the Agreement on the withdrawal of 
the  United  Kingdom  of  Great  Britain  and  Northern  Ireland  from  the  European  Union  and  the  European 
Atomic  Energy  Community 
at: 
https://commission.europa.eu/strategy-and-policy/relations-non-eu-countries/relations-united-kingdom/eu-
uk-withdrawal-agreement/protocol-ireland-and-northern-ireland_en. 

(OJ L 102, 

17.4.2023, 

24 March 

p. 87) 

2023 

see 

of 

(14)  As an example, Estonia already developed a national alert system. 

11 

 
 
 
 
4.6.  Perceptions held by both stakeholders and NCAs 

The  Falsified  Medicines  Directive  introduced  harmonised  European-wide  rules  to  fight 
medicine falsifications and ensure that patients receive safe medicines.  

The Delegated Regulation provides authorities with the tools they need to rigorously control 
the  trade  in  medicines  under  its  scope.  Its  provisions  received  a  positive  opinion  from  the 
NCAs.  

Supply-chain  operators  recognise  the  need  for  harmonised  rules  across  the  EU  and  the 
interconnected  repositories  system.  It  is  to  be  welcomed  that  EU  rules  will  end  divergent 
national  requirements  and  make  it  easier  to  monitor  the  movement  of  products  across  the 
EU/EEA.  

However, all the NCAs that responded to the survey conducted for the purpose of the Study 
considered that the supply chain in their region was already safe before the EU legislation was 
in place. The same is true for wholesalers and pharmacists (15). 

4.7.  Conclusions 

The purpose of the legislation was and remain to avoid that falsified medicinal products reach 
patients. The measures adopted aimed to balance the risks posed by falsified medicines with 
the administrative burden of preventing them.  
However, the incomplete implementation of the measures makes it impossible to properly and 
firmly assess the effect that they have had. 

For this reason, and based on figures regularly provided by the EMVO, the Commission has 
urged the Member States to comply with their obligations under the legislation and to ensure 
that the stakeholders involved comply as well. 

The Commission has been liaising with Member States to first  and foremost to increase: (i) 
the number of stakeholders connected to the repository system (i.e. pharmacies, wholesalers, 
persons  authorised/entitled  to  supply  medicinal  products  to  the  public);  and  (ii)  the 
decommissioning rates.  

Regular  exchanges  with  the  Member  States  are  ongoing  to  monitor  progress  towards  full 
compliance,  both  bilaterally  and  in  the  Expert  Group  set  for  the  purpose  of  the 
implementation of the legislation and through regular data reporting. As a result of this, there 
has  been  significant  progress  in  2023  with  regards  to  the  connection  of  community 
pharmacies.  

(15)  Outside  of  the  scope  of  this  report  on  falsified  medicinal  products,  manufacturers  and  marketing 
authorisation holders that were consulted promote the transformation of the verification system into a ‘track 
and  trace  system’.  Some  NCAs  support  this  idea  in  the  hope  that  such  a  system  could  serve  to  monitor, 
prevent and mitigate shortages of medicines. The information that is currently generated by the system does 
not provide an overview of stocks and volumes of medicinal products, and it does not provide the location of 
the  medicinal  packs.  The  system  was  not  designed  with  that  purpose.  Interoperability  with  other  systems 
outside  the  scope  of  the  Falsified  Medicines  Directive  and  its  Delegated  Regulation  could  be  analysed  as 
need be. 

12 

 
 
 
The  Commission  has  also  urged  the  NCAs  to  allocate  sufficient  resources  to  appropriately 
supervise the system at national level. 

The Commission is also closely monitoring the work of the EMVO to ensure that it delivers 
on its tasks.  
Thus,  although  significant  progress  has  been  noted  since  2023,  the  Commission  is  actively 
monitoring  the  following  challenges  and  engaging  with  the  national  authorities  and 
stakeholders to address them: 

in a limited number of countries, low level of connection of hospital pharmacies; 

• 
•  decommissioning rates; 
• 

technical  issues  triggering  considerable  numbers  of  false  alerts  that  consequently 
discourage stakeholders from using the system; 

•  diverging views between EMVO members, which can prevent strategic decisions from 

being taken; and 
the lack of guidance for the suitability of ATDs. 

• 

5.  OVERALL CONCLUSIONS AND NEXT STEPS 

It is critical that the measures in the Falsified Medicines Directive and Delegated Regulation 
are fully implemented to reach their full potential.  

The measures introduced by the Falsified Medicines Directive and Delegated Regulation have 
already had two main positive results:  

• 

• 

they make it more  difficult to introduce illegal products into the legal supply chain, so 
illegal products stay in the illegal circuit; and 
they generate data for investigators that make it possible to detect suspicious packages 
and track falsifying activities. 

So far, most cases of falsifications have been detected in the illegal supply chain  (including 
illegal websites or websites not authorised to provide medicinal products). 

Even when falsified medicinal products were identified in the legal supply chain, the national 
authorities, in collaboration with the supply-chain operators, promptly addressed the matter to 
remove the products from the legal supply chain.  

Considering  that  this  EU  legislation  is  still  in  the  process  of  being  implemented  in  all  the 
EU/EEA  countries,  and  given  that  confirmed  and  suspected  cases  of  falsification  are  not 
reported  centrally  at  EU  level,  it  is  currently  not  possible  to  make  a  complete  and  firm 
assessment of the impact of the Falsified Medicines Directive and Delegated Regulation.  

The Commission will, in cooperation with the NCAs and the supply-chain operators, further 
identify actions to address the remaining challenges and achieve full implementation, such as: 

•  Collaborating  closely  with  Greece  and  Italy  to  make  sure  they  comply  with  the  EU 

legislation by 9 February 2025,  

•  Continuing to check compliance by working bilaterally with the Member States, and 
leveraging  the  Member  State  Expert  Group  on  safety  features  for  them  to  exchange 

13 

 
 
• 

best  practices  and  take  a  strategic  approach  to  solve  current  challenges  with  the 
system,  
Identify  areas  where  the  development  of  possible  additional  guidance  documents 
could facilitate a common EU-wide approach to implementation e.g. in relation to the 
anti-tampering device and the follow-up of suspected packs, 

•  Collaborating with EMVO to explore the most effective actions to address the number 

of false alerts that remains above the desired level, and  

•  Continuing  to  participate  to  the  EMVO  Board  meeting  to  encourage  appropriate 
implementation  of  the  Delegated  Regulation  by  the  stakeholder  organisations 
represented in the board, and to encourage a collective and cohesive strategic approach 
supporting the functioning of the system.  

14