Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / Experiences on harmonization and mechanisms of sub-regional integration Argentinean Experience II Workshop on Medicines Regulation in the Caribbean Strengthening of National Medicines Regulation Authorities

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / Administración Nacional de Medicamentos Alimentos y Tecnología Médica

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / National Administration of Medicines, Food and medical Technologies (devices)

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / DEPENDENT THE MINISTRY OF HEALTH OF THE NATION MISSION: TO SUPERVISE AND CONTROL ALL PRODUCTS FOR USE IN HUMAN HEALTH MINISTERIO DE SALUD

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / NATIONAL INSTITUTE OF MEDICINE MEDICAL TECHNOLOGY DIRECTION MEDICINE EVALUATION DIRECTION LEGAL AFFAIRS DIRECTION ADMINISTRATIVE DIRECTION PLANIFICATION AND INTERNATIONAL RELATIONS DIRECTION NATIONAL DIRECTION NATIONAL INSTITUTE OF FOOD

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / OPS MERCOSUR ICH (EWG Q10 -PQS) PIC/S INTERNATIONAL RELATIONS AND PARTICIPATIONS

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / MERCOSUR BRAZIL URUGUAY PARAGUAY ARGENTINA CHILE, VENEZUELA, COLOMBIA, BOLIVIA, ECUADOR y PERU

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / SGT 11 of HEALTH PRODUCTS SEVERAL AD HOC GROUPS Psychotropic and Narcotic Herbal Medicines Blod Derivates Counterfeit Cosmétics Vaccines Others GMP

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / GMP WG DIFFICULTIES FOR HARMONIZATION of COMMON STANDARDS Diferent national laws Differences of criteria Disparity in resources Diferent procedures and mechanisms

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / STEPS FOLLOWED Identify the needs of each country Harmonization of common standards Harmonization of procedures Joint training of inspectors Joint Inspections

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / Workshops Workshops with international experts

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / Harmonization of common standards Res. GMC ( Common Market Group) Nº 59/92 : Guide for inspections of pharmaceutical industry. Res GMC 14/96 Verification of compliance with good manufacturing practices in pharmaceutical establishments (qualification of the Inspections Guide) Res GMC 23/96 Inspection procedures Res GMC 61/00 Adoption of the WHO GMP '92 Currently in harmonization for the use of GMP 'WHO 2003

JOIN training of inspectors MERCOSUR phase I training Course (internal in each country) Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / MERCOSUR phase II training Course (international) MERCOSUR phase III training Course (international)

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / Only inspectors with approved Phase II training course can perform MERCOSUR joint inspections

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / The armonization process is Continuous Continuous updating of harmonized standards

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / The GMP group is currently working on a unified report model with minimum standard content So… The armonization and the updating continues

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / NO MUTUAL RECOGNITION OF INSPECTIONS EXCHANGE OF INFORMATION WITH EXCHANGE OF INSPECTION REPORTS AND ANALYSIS OF THOSE REPORTS BY THE RECEPTOR COUNTRY, WHICH HAS THE DECISION POWER TO ACCEPT OR NOT, AND REQUEST THE JOINT INSPECTION.-

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / At that point the exchange of information with the possibility of its acceptance, it was after all we said before: years of joint inspections and joint training of inspectors

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / ASSISTED INSPECTION

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / ANMAT, through INAME, also interacts with PIC/S countries wich is full member since january 2008

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / BENEFITS Information and experiences exchange (with regulators from many countries (Europe, Asia, Africa) Join tarining for inspectors Joint inspections

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / Participation in Expert Circles (ANMAT participates in the expert circle of risk analysis) Rapid Alert Notifications System (receiving, from many countries in the world, quality defects notifications of products that may occasionally reach the Argentine market).

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: / THANKS FOR YOUR ATTENTION GRACIAS POR SU ATENCIÓN Rodolfo H. Mocchetto ANMAT – República Argentina