11 - 12 DECEMBER 2013 SHAKARYAN MKRTICH11 - 12 DECEMBER 2013 SHAKARYAN MKRTICH

AUTHORITY POSITION CONCERNING IMPLEMEN-TATION OF EFFICIENT

APPROACHS IN FIGHTING AGAINST  COUNTERFEITING OF MEDICAL

PRODUCTS

AUTHORITY POSITION CONCERNING IMPLEMEN-TATION OF EFFICIENT

APPROACHS IN FIGHTING AGAINST  COUNTERFEITING OF MEDICAL

PRODUCTS

What is the true picture?

$75 billion black market10,000 deaths every year

10 tons of counterfeit medicine seized

Customs seizeMillions of medicines

at border

400 counterfeit Medicines factories

shut down

Hospitals flooded with counterfeits

ALL THE TYPES OF MEDICAL PRODUCTS ARE ALL THE TYPES OF MEDICAL PRODUCTS ARE COUNTERFEITEDCOUNTERFEITEDALL THE TYPES OF MEDICAL PRODUCTS ARE ALL THE TYPES OF MEDICAL PRODUCTS ARE COUNTERFEITEDCOUNTERFEITED

Health is a social human right – counterfeiting of

medicines is a criminal act with a dramatic impact on the

health of the most vulnerable persons - patients

CONTRADICTION WITH HUMAN RIGHTS CONTRADICTION WITH HUMAN RIGHTS CONVENTIONCONVENTIONCONTRADICTION WITH HUMAN RIGHTS CONTRADICTION WITH HUMAN RIGHTS CONVENTIONCONVENTION

Territory: Territory: 29,74 thous. km.sq. Population: Population: 3,21 million

REPUBLIC OF ARMENIAREPUBLIC OF ARMENIA

LEGAL INSTRUMENTS AND PROCEDURES TO COMBAT AGAINST COUNTERFEITING

- 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

LEGAL INSTRUMENTS

Scientific Centre of Drug and Medical Technology Expertise of MoH of RA

REGULATION OF MEDICINAL PRODUCTS

LAW ON MEDICINES/1998GOVERNMENT DECREE 581/2000

IMPORT IMPORT CONTROLCONTROL

IMPORT AUTHORIZATIONIMPORT AUTHORIZATION

Customs code Products3001, 02, 03,04, 05, 06, 06, 06, 08 PHARMACEUTICAL PRODUCTS

2941 Antibiotics

1211 plants etc for pharmacy, perfume, insecticides etc

0510 ambergris, castoreum etc, glands etc for pharmacy

2904-2909, 2912-2940, 2942 ORGANIC CHEMICALS1301, 1302 lac, natural gums, resins, gum-resins and balsams

1504,1520 fats & oils, their fractions, fish & marine mammal1108 starches, inulin1702 sugars nesoi, incl. chem pure lactose etc, caramel1804, 1805 cocoa butter, fat and oil, cocoa powder, not sweetened2207, 2209 ethyl alcohol, undenat, n/un 80% alc, alcohol, 2712 petroleum jelly, mineral waxes & similar products2801, 2802, 2804, 2810, 2847, 2851 fluorine, chlorine, bromine & iodine

Permission

Documentation expertise and

identification with registration samples

Scientific Centre of Drug and Medical Technology Expertise of MoH of RA

8

Application

Preliminary expertise

Sampling

Final Expert Conclusion

Rejection

Quality Control of selected

medicines

Positive Inconsystency

Applications for import authorization: 2,000 – 2,300Applications for import authorization: 2,000 – 2,300Applications for import authorization: 2,000 – 2,300Applications for import authorization: 2,000 – 2,300

IMPORT AUTHORIZATIONIMPORT AUTHORIZATION

SAMPLINGIMPORT AUTHORIZATIONIMPORT AUTHORIZATION

COMPARISON WITH AUTHORIZED SAMPLES FROM THE DATA BASE OF DRACOMPARISON WITH AUTHORIZED SAMPLES FROM THE DATA BASE OF DRA

originaloriginalcounterfeitcounterfeit

microscopymicroscopy

IMPORT AUTHORIZATIONIMPORT AUTHORIZATION

QUALITY CONTROL FACILITIES

IMPORT AUTHORIZATIONIMPORT AUTHORIZATION

DATA BASE OF IMPORTED MEDICINESDATA 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

IMPORT AUTHORIZATIONIMPORT AUTHORIZATION

Scientific Centre of Drug and Medical Technology Expertise of MoH of RA

13

Import rejection from 1998-2012Import rejection from 1998-2012

IMPORT AUTHORIZATIONIMPORT AUTHORIZATION

COUNTERFEIT CASES DETECTED FROM 2001-2012

DETECTION OF COUNTERFEITDETECTION OF COUNTERFEITN

um

ber

of

Cas

es

Counterfeit Dietary Supplements

REGULATION OF MEDICINAL PRODUCTS

Contains undeclared ingredient

tadalafil 34.73mg Contains undeclared ingredient tadalafil

16.12mg

No marketing authorization for DS

DETECTION OF ILLEGAL MEDICINESDETECTION OF ILLEGAL MEDICINES

IMPORT AUTHORIZATIONIMPORT AUTHORIZATION

SAMPLING CUSTOMS PROCEDURE

CUSTOMS RELEASE

EXPERTISE OF DRA

C U S T O M S C O N T R O L

IMPORT

PART OF CUSTOMS CONTROLPART OF CUSTOMS CONTROL

50%50%

1%1%

CounterfeitCounterfeit

Counterfeit AUGMENTIN powder for injection

Contains ampicillin 1.396mg instead of the active ingredients- amoxicillin, clavulanic acid/ 1g+200mg

REGULATION OF MEDICINAL PRODUCTS

RegisteredRegistered

Counterfeit RocephinRocephin powder for solution for injection-2013

RegisteredRegistered CounterfeitCounterfeit

МОДЕРНИЗАЦИЯ ИНФОРМАЦИОННЫХ

ПРОЦЕССОВ В ЗДРАВОХРАНЕНИИ

МОДЕРНИЗАЦИЯ ИНФОРМАЦИОННЫХ

ПРОЦЕССОВ В ЗДРАВОХРАНЕНИИ

DEFINITION OF COUNTERFEITINGDEFINITION OF COUNTERFEITING- legislative - counterfeit, medical and medicinal product, victim, similar - legislative - counterfeit, medical and medicinal product, victim, similar crimecrimeb. in guidlines – pharmaceutical criminal activity, SPOC, signalb. in guidlines – pharmaceutical criminal activity, SPOC, signal

-PROVIDING FOR THE CRIMINALISATION OF CERTAIN ACT PROVIDING FOR THE CRIMINALISATION OF CERTAIN ACT - - Article 5 – Manufacturing of counterfeitsArticle 5 – Manufacturing of counterfeits

- Article 6 – Supplying, offering to supply, and trafficking in counterfeits –Article 6 – Supplying, offering to supply, and trafficking in counterfeits –- Article 7 – Falsification of documents Article 7 – Falsification of documents - Article 8 Similar crimes involving threats to public health Article 8 Similar crimes involving threats to public health

LEGAL PROVISION REGARDING TO COLLABORATION AND CO-LEGAL PROVISION REGARDING TO COLLABORATION AND CO-OPERATION BETWEEN AUTHORITIESOPERATION BETWEEN AUTHORITIES

- National measures of co-operation and information exchange- National measures of co-operation and information exchange- International co-operation- International co-operation

RATIFICATION OF MEDICRIMERATIFICATION OF MEDICRIME CONVENTION

COMPREHENSIVE TOOL IN COMBATING AGAINST COUNTERFEITINGS

MEDICRIME CONVENTION

MEDICRIME CONVENTIONChapter 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;

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;

MEDICRIME CONVENTION

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”.

COLLABOATION BETWEEN SPOCsCOLLABOATION BETWEEN SPOCsCOLLABOATION BETWEEN SPOCs

Clarify product’s licensing/distribution status (border,

retail, other level)

Is the medical product legally

marketed?

Does it comply with National

authorisations/ conformity

requirements’?

National SPOCcloses the case in agreement with national SPOCs network

Contain the incident e.g. quarantine, confiscation

Optional: authority assigns operational SPOC for coordination and adoption of

appropriate action

Co-ordination and taking of appropriate enforcement

action

Yes

Yes

NoDRA/Devices

Authority returns

information

NoDRA/

Devices Authority returns

information

Signal suspected case. Reported with all possible information to

Central Reporting Point for evaluation of signal

NationalNetwork among authorities of an individual state

DRA/Devices Authority for public health risk assessment

Penal imprisonmentction

(Fine,)

Other Administrative action (E.g. suspension of

establishment licence, or marketing

authorization)

Immediate action (E.g. seizure of product, recall,

dissemination of information)

NATIONAL AND INTERNATIONAL SPOCNATIONAL AND INTERNATIONAL SPOCHANDLING OF SIGNAL

National SPOCRole in

international/national co-operation; Central Reporting

Point

International

Co-operation

SPOC for

Customs

SPOC for

Police

SPOC for Other as needed

SPOC for

Judiciary

Industry Investigation SPOC e.g. Qualified/ Responsible Person)

SPOC for Medicines Regulatory Authority (DRA)incl. Official Medicines Control LaboratoriesCompetent Authorities for Medical Devices

SignalsGeneral public;

Health professionals

DRASPOCDRASPOC

NATIONAL AND INTERNATIONAL SPOC

SPOC DRA/SCDMTE

GMP/GDP INSPECTION

GMP/GDP INSPECTION

PHARMACOVIGILANCE INSPECTION

PHARMACOVIGILANCE INSPECTION

IMPORT/EXPORT AUTHORIZATION

DEPARTMENT

IMPORT/EXPORT AUTHORIZATION

DEPARTMENT

EVALUATION DEPARTMENTEVALUATION DEPARTMENT

DEPUTY HEAD SCDMTE

QUALITY CONTROL

LABORATORY

QUALITY CONTROL

LABORATORY

SCIENTIFIC CENTRE`S SPOCSCIENTIFIC CENTRE`S SPOC

ADMINISTRATION OFFICER

CUSTOMS POINTSFOR PASSENGERS

CUSTOMS POINTSFOR CARGO

COMBATING AGAINST SMAGLING PRODUCTS

Only 10 Medicines with 5 packs

8 Customs warehouses 8 Customs warehouses

CUSTOMS SPOCCUSTOMS SPOC

CRIMINAL CRIMINAL INVESTIGATION INVESTIGATION DEPARTMENTDEPARTMENT

GENERAL GENERAL DEPARTMENT ON DEPARTMENT ON

COMBATING COMBATING ORGANIZED ORGANIZED

CRIMECRIME

REGIONAL REGIONAL ADMINISTRAADMINISTRA

TIONTION

11 REGIONS

POLICE SPOCPOLICE SPOC

- Regular meetings with CustomsRegular meetings with Customs- Ad hoc meetings with Customs and PoliceAd hoc meetings with Customs and Police

COLLABORATION WITHIN SPOC NETWORK COLLABORATION WITHIN SPOC NETWORK

MEETINGS

TRAININGTRAINING

- Training of Customs personnel 3 Dec 2012Training of Customs personnel 3 Dec 2012- Planed training of Customs and Police personnelPlaned training of Customs and Police personnel

JOINT INSPECTIONS

- In Customs warehouses, pharmacies, In Customs warehouses, pharmacies, distributorsdistributors

POLICE SPOC

POLICE SPOC

JUDICARYSPOC

JUDICARYSPOCCUSTOMS

SPOCCUSTOMS

SPOC

DRASPOCDRA

SPOC

NATIONAL NETWORKNATIONAL NETWORK

NATIONAL NETWORK OF SPOCs

THE MEDICINES/DEVICE THE MEDICINES/DEVICE REGULATORY AUTHORITY REGULATORY AUTHORITY

SPOC IS RESPONSIBLE SPOC IS RESPONSIBLE FOR THE PUBLIC HEALTH FOR THE PUBLIC HEALTH

RISK ASSESSMENT OF RISK ASSESSMENT OF SUSPECTED/VERIFIED SUSPECTED/VERIFIED

CASES AND FOLLOW-UP CASES AND FOLLOW-UP TO THIS ASSESSMENTTO THIS ASSESSMENT

NATIONAL NETWORK OF SPOCs NATIONAL NETWORK OF SPOCs

CUSTOMS SPOC IS CUSTOMS SPOC IS RESPONSIBLE FOR RESPONSIBLE FOR

REPORTING REPORTING INFORMATION ON INFORMATION ON

DETECTCTED CASES DETECTCTED CASES TO DRA SPOCTO DRA SPOC

POLICE POLICE SPOC IS SPOC IS RESPONSIBLE FOR RESPONSIBLE FOR

REPORTING REPORTING INFORMATION ON INFORMATION ON

DETECTCTED CASES TO DETECTCTED CASES TO DRA SPOCDRA SPOC

POLICE POLICE SPOCSPOC

CUSTOMS CUSTOMS SPOCSPOCDRA SPOCDRA SPOC

PERMANENT INFORMAL SPOC

NETWORK

RAPIT ALERT NOTIFICATION FORM RAPIT ALERT NOTIFICATION FORM

NATIONAL SPOCNATIONAL SPOC

PUBLIC HEALTH PROTECTION SHOULD BE A PRIORITY

REACTIVE AND PROACTIVE CO-OPERATIONREACTIVE AND PROACTIVE CO-OPERATION

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

Armenia

Georgia

Russia

Moldova

Ukraine

Belarus

Khazakhstan

TRAINING AND QUALIFICATIONTRAINING AND QUALIFICATION

FIRST LEVEL REGIONAL TRAINING FOR THE 6 CIS COUNTRIES

TRAINING AND QUALIFICATIONTRAINING AND QUALIFICATION

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 АП 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

ЗАЩИТА ЗДОРОВЬЯ НАСЕЛЕНИЯ ЯВЛЯЕТСЯ ПРИОРИТЕТОМ

СПАСИБО ЗА ВНИМАНИЕ СПАСИБО ЗА ВНИМАНИЕ