The document outlines the EU Directive 2011/62/EU which addresses the issue of falsified medicinal products, detailing its adoption, provisions, and compliance requirements for various stakeholders in the medicinal supply chain. It specifies regulations concerning active substances, internet sales of medicines, and mandatory safety features to ensure the authenticity and integrity of medicines. The directive aims to combat counterfeit medicines and enhance the safety of pharmaceuticals within the EU.

1. Patrick Deboyser
Minister-Counsellor – EU Delegation to Thailand
Professor – European College of Parma
"EU legislation and strategy
to fight falsified medicines"
IFPMA-TFDA Workshop on Counterfeit Medicines
Friday 6th February 2015 - Taipei International Convention Center
TAIPEI, CHINESE TAIPEI

2. EU Directive 2011/62/EU on falsified medicinal products
 Adopted on 8 June 2011 by the European Parliament and the Council
 Published on 1 July 2011 in the Official Journal of the EU
 Came into application on 2 January 2013, except:
o Provisions on APIs (on 2 July 2013)
o Provisions on internet sales (2 July 2015)
o Proviusions on safety features (to be determined)
THE ‘FALSIFIED MEDICINES’ DIRECTIVE
EU STRATEGY TO COMBAT FALSIFIED MEDICINES

3. Any medicinal product with a false representation of:
 its identity, including its packaging and labelling, its name or its
composition as regards any of the ingredients including excipients
and the strength of those ingredients;
 its source, including its manufacturer, its country of manufacturing,
its country of origin or its marketing authorisation holder; or
 its history, including the records and documents relating to the
distribution channels used.
This definition:
 does not include unintentional quality defects and
 is without prejudice to infringements of intellectual property rights.
WHAT ARE ‘FALSIFIED MEDICINES’ ?
THE FALSIFIED MEDICINES DIRECTIVE

4. OVERVIEW OF PROVISIONS
THE FALSIFIED MEDICINES DIRECTIVE
Actors in the
supply chain
Active
substances
Directive
2011/62/EU
on falsified
medicinal
products
Internet
sales
Safety
features

5.  Wholesale distributors:
 Already regulated under EU rules since 1992
 Falsified Medicines Directive:
 Have to be listed in a EU database
 Are subject to Good Disribution Practices (GDP) for all
activities performed on the EU territory
 Have to report any suspicion of falsification.
 Brokers:
 Previously not regulated under EU rules
 Falsified Medicines Directive:
 Have to be registered
 Have obligations similar to those of wholesale distributors.
 The European Medicines Agency (EMA) has published
revised GDP guidelines which include specific provisions
for brokering activities.
ACTORS IN THE SUPPLY CHAIN
THE FALSIFIED MEDICINES DIRECTIVE
Actors in the
supply chain

6. ACTIVE SUBSTANCES
THE FALSIFIED MEDICINES DIRECTIVE
All APIs:
 Whether manufactured, imported or distributed in the EU (including
those intended for export from the EU).
 Must comply with Good Manufacturing Practices (GMP) and Good
Distribution Practices (GDP) for APIs.
 Must be subject to audits performed by medicines manufacturers or
third party contractor.
 „Written confirmation“ from the manufacturer on GMP compliance
becomes legally part of the application with:
 a reference to the time of the audit,
 a declaration that the outcome of the audit confirms the
compliance with GMP.
 All operators (manufacturers, importers, distributors of APIs) must
be registered with the competent authority where they are
established 60 days prior to commencement of activity (to allow for
inspection).

7. APIs imported from non-EU countries:
 Must be accompanied by a
 issued by the competent authority of the exporting country
 certifying that the APIs have been manufactured in compliance with
GMP standards at least equivalent to the GMP of the EU (ICH Q7)
 The Commission publishes a list of countries which, following their
request, have been assessed and are considered as having equivalent
rules for good manufacturing practices to those in the EU.
ACTIVE SUBSTANCES
THE FALSIFIED MEDICINES DIRECTIVE
WRITTEN CONFIRMATION
WAIVER

8. ACTIVE SUBSTANCES
THE FALSIFIED MEDICINES DIRECTIVE
COUNTRY STATUS
SWITZERLAND
ISRAEL In process
AUSTRALIA
BRAZIL In process
JAPAN
U.S.A.
NEW ZEALAND In process
KOREA In process
WAIVER
WAIVER
WAIVER
WAIVER

9. ACTIVE SUBSTANCES
THE FALSIFIED MEDICINES DIRECTIVE
APIs imported from non-EU countries: State of play
 Rules smoothly entered into force on 2 July 2013
 No significant shortages of API or any other critical
situation reported.
 Most API sites are now covered with written
confirmation or exempted because of "listing" of the
non-EU country.
 The renewal of written confirmations is also
proceeding timely, without disruption of supply.

10. ACTIVE SUBSTANCES
THE FALSIFIED MEDICINES DIRECTIVE
Non-EU
country
N° of API sites
supplying to EU
State of play
India 496 IND issued 274 written confirmations.
China 438 CHN issued approximately 900 written
confirmations. A database containing all written
confirmations has been set up.
U.S. 186 Listed.
Japan 108 Listed.
Switzerland 67 Listed.
South Korea 37 S. Korea has issued 54 written confirmations for
105 APIs (as of Aug 2013).
Israel 36 Israel has issued 160 written confirmations (as of
Aug 2014).
Mexico 35 MEX has issued 9 written confirmations (as of
Aug 2013). Interested in applying for “listing”.
Brazil 23 BRA has applied for listing. Assessment ongoing.
BRA has issued 11 written confirmations covering
56 APIs.
Canada 17 CAN has issued 13 written confirmations (as of
Aug 2014).

11. ACTIVE SUBSTANCES
THE FALSIFIED MEDICINES DIRECTIVE
Non-EU
country
N° of API sites
supplying to EU
State of play
Chinese
Taipei
16 Chinese Taipei has issued 76 written
confirmations to 18 API manufacturers.
Planning to apply for “listing” in early 2015.
Argentina 12 ARG has issued 16 written confirmations
covering 36 API (as of Aug 2014). Interested
in applying for “listing”
Turkey 12 TUR has issued 12 'written confirmations'
covering 212 API (Aug 2014).
Malaysia 7 MYS has issued 4 written confirmations (Aug
2014).
Singapore 7 SGP has issued 9 written confirmations (Aug
2014).
Thailand 6 THA has informed COM that they are going
to issue written confirmations.
Australia 5 Listed.
Russia 5 RUS has informed COM that they are going
to issue written confirmations.
Ukraine 4 UKR has issued written confirmation.
South Africa 2 ZAF has issued written confirmation.

12. INTERNET SALES
THE FALSIFIED MEDICINES DIRECTIVE
 The Falsified Medicines Directive does not affect some
basis rules regarding the distribution of medicines:
 EU Members States may still ban online sale of the prescription
medicines.
 Medicines sold through internet have to comply with the law of
Member states they are being sold to.
 The Falsified Medicines Directive provides that:
 Each EU Member states has to create a website with the list of
all legally operating online retailers, established on the territory of
that Member State.
 An obligatory logo will appear on the websites of legally
operating online pharmacies in the EU.The logo will allow patients
and consumers to identify authorised online pharmacies
providing authentic, authorised medicines.
 Clicking on the logo will link to the national regulatory authority
websites, where all legally operating online pharmacies in their
respective countries will be listed.
Internet
sales

13. INTERNET SALES
THE FALSIFIED MEDICINES DIRECTIVE
 The Implementing Regulation establishing the new logo
entered into force in July 2014, giving Member States
until July 2015 to prepare for its application.
 Online pharmacies/retailers have:
 to be authorised by the Member State of establishment,
 to display the ‘common logo’
 to supply medicines authorised in the Member State of
destination, where the patient is located (package,
language, legal status).
Internet
sales

14. SAFETY FEATURES
THE FALSIFIED MEDICINES DIRECTIVE
 The purpose of the ‘safety features’ is to allow the detection of
falsified medicines before they reach the patient.
 The ‘safety features’ will enable wholesale distributors and
pharmacists:
 to verify the authenticity of the medicinal product,
 to identify individual packs,
 to verify, by means of a device, whether the outer packaging has
been tampered with.
 The ‘safety features' will be compulsory for prescription-only
medicines and for some non-prescription medicines, to be determined
through implementing measures.
 The characteristics and technical specifications of the 'safety features‘,
such as the unique identifier for individual packs, will be laid down in
implementing measures to be adopted in 2015.
Safety
features
UNIQUE IDENTIFYER ANTI-TAMPERING DEVICE+

15. Close cooperation between:
 The European Commission
 The European Medicines Agency (EMA)
 The EU Member States
 The European Directorate for the Quality of Medicines and Healthcare
(EDQM) and
 The World Health Organization's International Medical Products Anti-
Counterfeiting Taskforce (IMPACT).
The EU legislation and strategy to fight falsified medicines"
EU STRATEGY TO COMBAT FALSIFIED MEDICINES

16. Thank you
sanco-pharmaceuticals-d6@ec.europa.eu