Medicines and Medical Devices Agency of Serbia (ALIMS)

Medicines and Medical Devices Agency of Serbia (ALIMS)

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)
Agencija za lekove i medicinska sredstva Srbije
National Regulatory Authority Expert
www.alims.gov.rs
www.alims.gov.rs
www.alims.gov.rs
10% of medicines could be counterfeit worldwide
Source : WHO
- Approximatively 50% of drugs sold on illegal Internet
sites might be counterfeit (source: WHO)
>30% counterfeit
>20% counterfeit
<10% counterfeit
#1% counterfeit
www.alims.gov.rs
Counterfeit Drugs : weak risks/ big profits
For 1.000 $ invested, profits can reach:
Counterfeit
Money
$18000
HEROINE
$20.000
Counterfeit
CIGARETTES
$43.000
Counterfeit
Medicines
$200.000 to
$450.000
www.alims.gov.rs
www.alims.gov.rs
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
www.alims.gov.rs
ALIMS - Organisation Chart
www.alims.gov.rs
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 17025 (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
www.alims.gov.rs
ALIMS website – www.alims.gov.rs
www.alims.gov.rs
www.alims.gov.rs
ALIMS and it’s representatives
regularly appear in printed and
electronic media and transfer
important messages to general
public
2012 – 876
2013 – 862
2014 – 960
www.alims.gov.rs
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
www.alims.gov.rs
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
www.alims.gov.rs
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
www.alims.gov.rs
Agreements and
contracts on expert
technical and business
cooperation
Agence Nationale du Médicament Vétérinaire (ANMV)
www.alims.gov.rs
First regional agreement between:
www.alims.gov.rs
Membership in International Organizations
and Multilateral Cooperation
+ Working Group of Enforcement Officers (WGEO) - Heads of
Medicines Agencies (HMA)
www.alims.gov.rs
Bilateral Cooperation
www.alims.gov.rs
Bilateral Cooperation
www.alims.gov.rs
Multilateral Cooperation
www.alims.gov.rs
Support and Cooperation in Serbia
www.alims.gov.rs
Support and Cooperation in Serbia
www.alims.gov.rs
www.alims.gov.rs
Medicrime comics
- Psychological background
- Two age groups: 8-11 (OPEN MINDS, FREE MINDS), 1215 (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
www.alims.gov.rs
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)
www.alims.gov.rs
www.alims.gov.rs
• 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
www.alims.gov.rs
www.alims.gov.rs
THANK YOU!
www.alims.gov.rs