session1: patrick deboyser, european union
Upload: international-federation-of-pharmaceutical-manufacturers-associations-ifpma
Post on 16-Jul-2015
228 views
TRANSCRIPT
Patrick DeboyserMinister-Counsellor – EU Delegation to Thailand
Professor – European College of Parma
"EU legislation and strategyto fight falsified medicines"
IFPMA-TFDA Workshop on Counterfeit MedicinesFriday 6th February 2015 - Taipei International Convention Center
TAIPEI, CHINESE TAIPEI
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
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
OVERVIEW OF PROVISIONS
THE FALSIFIED MEDICINES DIRECTIVE
Actors in the supply chain
Activesubstances
Directive2011/62/EUon falsifiedmedicinalproducts
Internetsales
Safetyfeatures
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 thesupply chain
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).
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
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
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.
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).
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.
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 prescriptionmedicines.
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 pharmaciesproviding 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.
Internetsales
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).
Internetsales
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.
Safetyfeatures UNIQUE IDENTIFYER ANTI-TAMPERING DEVICE+
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
