11 - 12 DECEMBER 2013 SHAKARYAN MKRTICH

1. AUTHORITY POSITION CONCERNING IMPLEMEN-TATION OF EFFICIENT APPROACHS IN FIGHTING AGAINST  COUNTERFEITING OF MEDICAL PRODUCTS 11 - 12 DECEMBER 2013 SHAKARYAN MKRTICH

2. What is the true picture? $75 billion black market 10,000 deaths every year Customs seize Millions of medicines at border 400 counterfeit Medicines factories shut down Hospitals flooded with counterfeits 10 tons of counterfeit medicine seized

3. ALL THE TYPES OF MEDICAL PRODUCTS ARE COUNTERFEITED

4. Health is a social human right – counterfeiting of medicines is acriminal act with a dramatic impact on the health of the mostvulnerable persons - patients CONTRADICTION WITH HUMAN RIGHTS CONVENTION

5. REPUBLIC OF ARMENIA REPUBLIC OF ARMENIA Territory: 29,74 thous. km.sq. Population: 3,21 million

6. LEGAL INSTRUMENTS AND PROCEDURES TO COMBAT AGAINST COUNTERFEITING LEGAL INSTRUMENTS • ARMENIAN CRIMINAL CODE, 2006 • WHO RECOMMENDATIONS, DEFINITIONS, IMPACT • CIS AGREEMENT “ON COMBATING AGAINST COUNTERFEITINGS” 2008 • SIGNATURE OF MEDICRIME, 20 SEPTEMBER 2012 • ESTABLISHING SPOCs, SPOC NETWORKS • TRAINING ON EDQM PLATFORM IN YEREVAN NOVEMBER 8-9 2012

7. IMPORT AUTHORIZATION REGULATION OF MEDICINAL PRODUCTS LAW ON MEDICINES/1998 GOVERNMENT DECREE 581/2000 IMPORT CONTROL Scientific Centre of Drug and Medical Technology Expertise of MoH of RA

8. IMPORT AUTHORIZATION Application Applications for import authorization: 2,000 – 2,300 Preliminary expertise Sampling Documentation expertise and identification with registration samples Quality Control of selected medicines Final Expert Conclusion Inconsystency Positive Permission Rejection Scientific Centre of Drug and Medical Technology Expertise of MoH of RA 8

9. SAMPLING IMPORT AUTHORIZATION

10. IMPORT AUTHORIZATION microscopy counterfeit original COMPARISON WITH AUTHORIZED SAMPLES FROM THE DATA BASE OF DRA

11. IMPORT AUTHORIZATION QUALITY CONTROL FACILITIES

12. IMPORT AUTHORIZATION DATA BASE OF IMPORTED MEDICINES - Name and address of the Importer- Name and address of the Supplier- Medicines name, dosage form, strength, - Manufacturer and holder of marketing authorization- Unit price - Quantity - Batch number - Expiry date

13. IMPORT AUTHORIZATION Import rejection from 1998-2012 Scientific Centre of Drug and Medical Technology Expertise of MoH of RA 13

15. DETECTION OF COUNTERFEIT COUNTERFEIT CASES DETECTED FROM 2001-2012 Number of Cases

16. DETECTION OF ILLEGAL MEDICINES REGULATION OF MEDICINAL PRODUCTS Counterfeit Dietary Supplements Contains undeclared ingredienttadalafil 34.73mg Contains undeclared ingredienttadalafil 16.12mg No marketing authorization for DS

17. IMPORT AUTHORIZATION PART OF CUSTOMS CONTROL EXPERTISE OF DRA 50% M A R K E T CUSTOMS PROCEDURE SAMPLING CUSTOMS RELEASE IMPORT C U S T O M S C O N T R O L 1%

18. REGULATION OF MEDICINAL PRODUCTS Counterfeit AUGMENTIN powder for injection Contains ampicillin 1.396mginstead of the active ingredients- amoxicillin, clavulanic acid/1g+200mg Registered Counterfeit

19. Counterfeit Rocephin powder for solution for injection-2013 Registered Counterfeit

20. МОДЕРНИЗАЦИЯ ИНФОРМАЦИОННЫХ ПРОЦЕССОВ В ЗДРАВОХРАНЕНИИ

21. MEDICRIME CONVENTION • RATIFICATION OF MEDICRIME CONVENTION • DEFINITION OF COUNTERFEITING • - legislative - counterfeit, medical and medicinal product, victim, similar crimeb. in guidlines – pharmaceutical criminal activity, SPOC, signal • PROVIDING FOR THE CRIMINALISATION OF CERTAIN ACT • - Article 5 – Manufacturing of counterfeits • Article 6 – Supplying, offering to supply, and trafficking in counterfeits – • Article 7 – Falsification of documents • Article 8 Similar crimes involving threats to public health • LEGAL PROVISION REGARDING TO COLLABORATION AND CO-OPERATION BETWEEN AUTHORITIES • - National measures of co-operation and information exchange • - International co-operation COMPREHENSIVE TOOL IN COMBATING AGAINST COUNTERFEITINGS

22. MEDICRIME CONVENTION MEDICRIME CONVENTION Chapter V –Measures for prevention Article 18 - Preventive measures 1. Each Party shall take the necessary legislative and other measures to establish the quality and safety requirements of medical products. 2. Each Party shall take the necessary legislative and other measures to ensure the safe distribution of medical products. 3. With the aim of preventing counterfeiting of medical products, active substances, excipients, parts, materials and accessories, each Party shall take the necessary measures to provide, inter alia, for: a   training of healthcare professionals, providers, police and customs authorities, as well as relevant regulatory authorities;b   the promotion of awareness-raising campaigns addressed to the general public providing information about counterfeit medical products;

23. COLLABOATION BETWEEN SPOCs COLLABOATION BETWEEN SPOCs COLLABOATION BETWEEN SPOCs • FOR COOPERATION WITHIN AN INDIVIDUAL COUNTRY: A NETWORK AMONG SINGLE POINTS OF CONTACT (SPOCS) WITHIN THE DIFFERENT COMPETENT AUTHORITIES • FOR INTERNATIONAL COOPERATION AMONG STATES, THE NATIONAL SPOCS NETWORK IS REPRESENTED BY A “NATIONAL” SPOC”.

24. NATIONAL AND INTERNATIONAL SPOC Signal suspected case. National Network among authorities of an individual state Clarify product’s licensing/ distribution status (border, retail, other level) Reported with all possible information to Central Reporting Point for evaluation of signal Is the medical product legally marketed? DRA/Devices Authority for public health risk assessment No DRA/Devices Authority returns information Yes Does it comply with National authorisations/ conformity requirements’? Contain the incident e.g. quarantine, confiscation Optional: authority assigns operational SPOC for coordination and adoption of appropriate action Yes No DRA/Devices Authority returns information Co-ordination and taking of appropriate enforcement action National SPOC closes the case in agreement with national SPOCs network Immediate action (E.g. seizure of product, recall, dissemination of information) Other Administrative action (E.g. suspension of establishment licence, or marketing authorization) Penal imprisonmentction (Fine,) HANDLING OF SIGNAL

25. National SPOCRole in international/national co-operation; Central Reporting Point Industry Investigation SPOC e.g. Qualified/ Responsible Person) International Co-operation SPOC for Police SPOC for Judiciary SPOC for Customs SPOC for Medicines Regulatory Authority (DRA) incl. Official Medicines Control Laboratories Competent Authorities for Medical Devices SPOC for Other as needed Signals General public; Health professionals NATIONAL AND INTERNATIONAL SPOC DRA SPOC

26. SCIENTIFIC CENTRE`S SPOC SPOC DRA/SCDMTE DEPUTY HEAD SCDMTE QUALITY CONTROL LABORATORY GMP/GDP INSPECTION IMPORT/EXPORT AUTHORIZATION DEPARTMENT EVALUATION DEPARTMENT PHARMACOVIGILANCE INSPECTION

27. CUSTOMS SPOC ADMINISTRATION OFFICER COMBATING AGAINST SMAGLING PRODUCTS CUSTOMS POINTS FOR PASSENGERS CUSTOMS POINTS FOR CARGO Only 10 Medicines with 5 packs 8 Customs warehouses 8 Customs warehouses

28. POLICE SPOC GENERAL DEPARTMENT ON COMBATING ORGANIZED CRIME REGIONAL ADMINISTRATION CRIMINAL INVESTIGATION DEPARTMENT 11 REGIONS

29. Regular meetings with Customs Ad hoc meetings with Customs and Police COLLABORATION WITHIN SPOC NETWORK MEETINGS TRAINING • Training of Customs personnel 3 Dec 2012 • Planed training of Customs and Police personnel JOINT INSPECTIONS • In Customs warehouses, pharmacies, distributors

30. NATIONAL NETWORK OF SPOCs NATIONAL NETWORK POLICE SPOC DRA SPOC JUDICARYSPOC CUSTOMS SPOC

31. NATIONAL NETWORK OF SPOCs CUSTOMS SPOC DRA SPOC POLICE SPOC THE MEDICINES/DEVICE REGULATORY AUTHORITY SPOC IS RESPONSIBLE FOR THE PUBLIC HEALTH RISK ASSESSMENT OF SUSPECTED/VERIFIED CASES AND FOLLOW-UP TO THIS ASSESSMENT POLICE SPOC IS RESPONSIBLE FOR REPORTING INFORMATION ON DETECTCTED CASES TO DRA SPOC CUSTOMS SPOC IS RESPONSIBLE FOR REPORTING INFORMATION ON DETECTCTED CASES TO DRA SPOC PERMANENT INFORMAL SPOC NETWORK

32. RAPIT ALERT NOTIFICATION FORM

33. NATIONAL SPOC REACTIVE AND PROACTIVE CO-OPERATION PUBLIC HEALTH PROTECTION SHOULD BE A PRIORITY

34. COMBATING COUNTERFEITING OF MEDICINES AND SIMILAR CRIMES AND PROTECTING PUBLIC HEALTH THROUGH LEGAL INSTRUMENTS, AWARENESS-RAISING AND CO-OPERATION ON COUNTRY AND MULTINATIONAL LEVELS

35. TRAINING AND QUALIFICATION FIRST LEVEL REGIONAL TRAINING FOR THE 6 CIS COUNTRIES Armenia Georgia Russia Moldova Ukraine Belarus Khazakhstan

36. TRAINING AND QUALIFICATION

37. П О З И Ц И Я Р Е Г У Л Я Т О Р Н О Г О О Р Г А Н А ЗАЩИТА ЗДОРОВЬЯ НАСЕЛЕНИЯ ЯВЛЯЕТСЯ ПРИОРИТЕТОМ СПАСИБО ЗА ВНИМАНИЕ