1. Agência Nacional de Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA EXPERT GROUP CONCERNING PHARMACEUTICAL PRODUCTS MEETING Kleber Pessoa de Melo Kleber Pessoa de Melo Chefe da Unidade de Produtos Controlados Brasilia-DF (August 25-27, 2003 ) FINAL REPORT BRAZILIAN PRESIDENCY

2. Agência Nacional de Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA Member States Participated Thirty-nine experts from the following member states participated

3. Agência Nacional de Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA Working Sessions Review and finalize the Guides for Control Systems, Industry and Health Professionals.Review and finalize the Guides for Control Systems, Industry and Health Professionals. Implementation of MEM Hemispheric recommendationsImplementation of MEM Hemispheric recommendations Reviewing the items remaining on the plan of action.Reviewing the items remaining on the plan of action. Presentation by the delegation of Brazil concerning the national pharmaceutical control system that is currently being developed and implemented in Brazil.Presentation by the delegation of Brazil concerning the national pharmaceutical control system that is currently being developed and implemented in Brazil.

4. Agência Nacional de Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA Guides Elements for the Control of Pharmaceutical Products Mexico and USA Reviewed Finalized Guide for Health Professionals Chile and Venezuela Reviewed Revised Format Canada and Uruguay Guide for Industry Colombia and Brazil Revised Format Deferred

5. Agência Nacional de Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA MEM Recommendation 8. Conduct a thorough review of domestic regulations for the control of Pharmaceuticals and strengthen coordination mechanisms among the relevant sectors. The Commission should encourage member states to: review and update their national legislation and regulations The Executive Secretariat should: establish a section in the CICAD web page concerning the control of pharmaceutical products link to web pages maintained by member states national pharmaceutical control legislation and regulations substances that they control the name and contact information of a person provide technical legal assistance

6. Agência Nacional de Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA MEM Recommendation 10. Implement a hemispheric communication and coordination system in order to improve and facilitate cooperation and coordination among member states on matters related to control of pharmaceutical products and controlled chemical substances at the national and international levels. Executive Secretariat : directory of operational points of contact directory of official Competent Authorities (INCB) CICAD / INCB plan of action for National Drug Control Database (NDS) implementation Expert group: review existing best practices for communication and coordination for discussion during the next expert group meeting development of a reference paper

7. Agência Nacional de Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA Recommendations Member states Executive Secretariat Group of Experts

8. Agência Nacional de Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA Executive Secretariat Web page Technical Legal Assistance CICAD / INCB implementation of NDS Pilot training seminar – –Implementation of the elements guide – –Caribbean

9. Agência Nacional de Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA Group of Experts 1. 1.Group of Experts to meet in 2004 Plan of action: 1. 1.Finalize the Guide for Health Professionals 2. 2.Develop a guide of best practices for communication and coordination 3. 3.Develop a guide of best practices to overcome impediments to effective implementation of regulations and control systems (Chile) 4. 4.Develop a guide of best practices for mechanisms to strengthen inspection, investigation and other control activities

10. Agência Nacional de Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA THANK YOU