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Experiences on harmonization and mechanisms of sub-regional integration

II Workshop on Medicines Regulation in the Caribbean “Strengthening of National Medicines Regulation Authorities”. Experiences on harmonization and mechanisms of sub-regional integration. Argentinean Experience.

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Experiences on harmonization and mechanisms of sub-regional integration

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  1. II Workshop on Medicines Regulation in the Caribbean “Strengthening of National Medicines Regulation Authorities” Experiences on harmonization and mechanisms of sub-regional integration Argentinean Experience Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  2. AdministraciónNacionaldeMedicamentosAlimentosyTecnologíaMédicaAdministraciónNacionaldeMedicamentosAlimentosyTecnologíaMédica Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  3. National Administration of Medicines, Food and medical Technologies (devices) Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  4. Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200 DEPENDENT THE MINISTRY OF HEALTH OF THE NATION MINISTERIO DE SALUD MISSION: TO SUPERVISE AND CONTROL ALL PRODUCTS FOR USE IN HUMAN HEALTH

  5. NATIONAL DIRECTION NATIONAL INSTITUTE OF MEDICINE NATIONAL INSTITUTE OF FOOD MEDICINE EVALUATION MEDICAL TECHNOLOGY DIRECTION DIRECTION LEGAL AFFAIRS DIRECTION ADMINISTRATIVE DIRECTION PLANIFICATION AND INTERNATIONAL RELATIONS DIRECTION Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  6. OPS MERCOSUR INTERNATIONAL RELATIONS AND PARTICIPATIONS ICH (EWG Q10 -PQS) PIC/S Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  7. MERCOSUR BRAZIL URUGUAY PARAGUAY ARGENTINA CHILE, VENEZUELA, COLOMBIA, BOLIVIA, ECUADOR y PERU Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  8. 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: 54-11-4340-0800 / 54-11-5252-8200

  9. GMP WG • DIFFICULTIES FOR HARMONIZATIONof 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: 54-11-4340-0800 / 54-11-5252-8200

  10. 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: 54-11-4340-0800 / 54-11-5252-8200

  11. Workshops • Workshops with international experts Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  12. Harmonizationof 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 Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  13. MERCOSUR phase I training Course (internal in each country) JOIN training of inspectors MERCOSUR phase II training Course (international) MERCOSUR phase III training Course (international) Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  14. Only inspectors with approved Phase II training coursecan perform MERCOSUR joint inspections Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  15. The armonization process is Continuous • Continuous updating of harmonized standards Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  16. 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: 54-11-4340-0800 / 54-11-5252-8200

  17. 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: 54-11-4340-0800 / 54-11-5252-8200

  18. 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: 54-11-4340-0800 / 54-11-5252-8200

  19. ASSISTED INSPECTION Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

  20. 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: 54-11-4340-0800 / 54-11-5252-8200

  21. 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: 54-11-4340-0800 / 54-11-5252-8200

  22. 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: 54-11-4340-0800 / 54-11-5252-8200

  23. THANKS FOR YOUR ATTENTION GRACIAS POR SU ATENCIÓN Rodolfo H. Mocchetto ANMAT – República Argentina rmocchetto@anmat.gov.ar Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

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