Agencija za lekove i medicinska sredstva Srbije Cooperation and education concerning fake medicines in Serbia Pavle Zelic, Phar.B. International Cooperation and Public Relations Manager Medicines and Medical Devices Agency of Serbia (ALIMS)

National Regulatory Authority Expert

10% of medicines could be counterfeit worldwide - Approximatively 50% of drugs sold on illegal Internet sites might be counterfeit (source: WHO) Source : WHO >30% counterfeit >20% counterfeit <10% counterfeit #1% counterfeit

Counterfeit CIGARETTES Counterfeit Medicines HEROINE Counterfeit Money For $ invested, profits can reach: $ $18000 $ to $ $ Counterfeit Drugs : weak risks/ big profits

IMPORTANT STEPS TO TAKE -Perception in the public (general, professional, media, industry, gov.) – take proactive role -Campaigns and publications -NRA networking – national, bilateral, regional, international, multilateral cooperation -Cooperation with patients and healthcare professional’s organizations – mutually beneficial -Availability of medicines (for smaller countries) -Education and training – synergy with academia -Responsibility, transparency, crisis management, ethics, cost – issues of concern that affect trust

ALIMS - Organisation Chart

National Control Laboratory (NCL) is the organisational unit within the Medicines and Medical Devices Agency of Serbia (ALIMS) NCL is in accordance to the relevant standards GMP, GLP, ISO 9001, ISO 14001, ISO (by Accreditation Body of Serbia - ATS) and EDQM NCL is a full member of OMCL Network since 2004 According to: Law on Medicines and Medical Devices ("Official Gazette of the Republic of Serbia“, No. 30/2010) Regulations on the Medicines and Medical Devices Quality Control (“Official Gazette of the Republic of Serbia", No. 64/2011) NCL is authorized to perform quality control of medicinal products and medical devices for human and veterinary use

ALIMS website –

ALIMS and it’s representatives regularly appear in printed and electronic media and transfer important messages to general public 2012 – – – 960

National cooperation in fight against fake medicines Cooperation between: Ministry of Health Ministry of Internal Affairs/Police Customs Administration Prosecutors Office Intellectual Property Office ALIMS Implementation of the EDQM SPOC model

International cooperation WHO (alerts and reports) EDQM - Committee of Experts on Minimising the Public Health Risks Posed by Counterfeiting of Medical Products and Related Crimes (CD-P-PH/CMED) WGEO group of Heads of Medicines Agencies (representatives for human and veterinary medicines) Fakeshare project (Italian Medicines Agency) Preparation for signing a Medicrime Convention Regional cooperation Pôle régional de lutte contre la criminalité organisée en Europe du Sud-Est (Pôle de Belgrade – office of French governement) Pangea operation

Cooperation through the OMCL Network and with EDQM in anti-counterfeit activities Training and meetings EDQM regularly organizes educational programs on counterfeits testing with focus on specific analytical techniques Suspicious Unknown Products (SUP) - aims to evaluate the ability of OMCLs to identify (and where possible quantify) unknown active pharmaceutical ingredients (APIs) in a selected sample OMCL database - different reports collected from OMCLs within the Network ‘Know-X’ database - Linkage of information about counterfeits and illegal medicines facilitated through the database, which collates reports generated by OMCLs, customs, police and health authorities

Agence Nationale du Médicament Vétérinaire (ANMV) Agreements and contracts on expert technical and business cooperation

First regional agreement between:

+ Working Group of Enforcement Officers (WGEO) - Heads of Medicines Agencies (HMA) Membership in International Organizations and Multilateral Cooperation

Bilateral Cooperation

Bilateral Cooperation

Multilateral Cooperation

Support and Cooperation in Serbia

Support and Cooperation in Serbia

- Psychological background - Two age groups: 8-11 (OPEN MINDS, FREE MINDS), (OPEN MINDS, FREE MINDS, WINNER LIVES) - Key messages - Interactive story (choose your own adventure) – PDF and Webcomic - Age appropriate drawings - Teaching concept designed by psycologists - Web tool and teaching tool Medicrime comics

- Financing – EDQM (CoE) - 4 months - 6 consultants (3 psychologists – Italy, 1 artist Serbia, 2 IT experts Italy/Serbia) - 2 coordinators (Domenico Di Giorgio – AIFA, Pavle Zelic - ALIMS) Medicrime comics

Memorandum of Understanding – ALIMS and AIFA (since July 7th 2014) Fakeshare – support and cooperation through project Interactive comic book (print and online) Published in Italy and Serbia Advertised to general public and on events

THANK YOU!