InmetroMinistry of Development Brazilian Government Seminar on Good Regulatory Practices The Brazilian Guide on Good Regulatory Practices Alfredo Lobo.

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InmetroMinistry of Development Brazilian Government Seminar on Good Regulatory Practices The Brazilian Guide on Good Regulatory Practices Alfredo Lobo Director of Quality, Inmetro, BRAZIL Geneva, 18 th, March, 2008

InmetroMinistry of Development Brazilian Government Brazilian Guide on Good Regulatory Practices - Approach - - Organization and management - Objectives - References used - Relevant topics - Dissemination and implementation Plan

InmetroMinistry of Development Brazilian Government Brazilian Guide on Good Regulatory Practices CONMETRO ADVISORY COMMITTEES CBAC Conformity Assessment CBR Technical Regulations CBM Metrology CBN Standardization CCAB Codex Alimentarius - SINMETRO Framework -

InmetroMinistry of Development Brazilian Government Brazilian Guide on Good Regulatory Practices - Objectives - - To facilitate the implementation of international, multilateral, regional and bilateral agreements, considering the Brazilian signatory position, aligning with the international regulatory practices; - To contribute on the promotion of a major integration among Brazilian regulatory authorities; -To contribute to harmonization, consistency and coherence in regulatory practices adopted by Brazilian authorities; - To contribute to improvement and incentive of technical standards adoption in the elaboration process of technical regulations; - To contribute to the international recognition of conformity assessment practices adopted in Brazil; and - To act as an effective instrument for Brazilian industrial and foreign trade polices, promoting the innovation, the social, economical and technological development of Brazil, therefore, facilitating the its international insertion.

InmetroMinistry of Development Brazilian Government - Elaboration Process -  Participation: -The effective participation on the elaboration of the national guide on GRP: -14 central government agencies, among 27 existing agencies.  Main actions: - Consultancy for the text elaboration (a well-known professional in this area) - Workshop (counting on the central government regulatory authorities participation) - Four meetings to reach the consensus - Final workshop (to analyze and discuss the comments received from the stakeholders) - Conmetro approval  Process Period: - July /2006- December/2007 Brazilian Guide on Good Regulatory Practices

InmetroMinistry of Development Brazilian Government - References used - ISO/IEC - Using and referencing ISO/ IEC standards for technical regulations, 2007; WTO Agreements (TBT, SPS, TRIPS, GATS); OECD - Guiding Principles for Regulatory Quality and Performance and the OECD Reference Checklist for Regulatory Decision-Making, 1995; EU - Mandelkern Group on Better Regulation: Final Report., 2001 and other EU publications; APEC - Information Notes on Good Practice for Technical Regulation, Brazilian Guide on Good Regulatory Practices

InmetroMinistry of Development Brazilian Government SUMARY 1. Introduction 2. Scope 3. Terms, definition and acronyms 4. References 5. General Principles on Good Regulatory Practices 6 Technical Regulation: Structure and Content 6.2 Application 6.5 Conformity Assessment Procedures 6.6 General & Transitory Provisions 7 Technical Regulation: Elaboration 7.2 Risk Impact Assessment on the Regulation 7.3 Evaluation of the Relationship with the Legislation and Agreements 7.5 Notification, Consultation and Public Sessions - Relevant Topics - Brazilian Guide on Good Regulatory Practices

InmetroMinistry of Development Brazilian Government 8 Technical Regulation Adoption 8.1 Approval & Publication 8.2 Proceedings in Urgent Situations 9 Technical Regulation Implementation 9.1 Preliminary Cares 9.2 Implementation Period 9.3 Assisted Implementation 9.4 Common Technological Base (the required infrastructure) 9.5 Inspection 9.6 Market Surveillance Practices 10. Final Considerations 10.1 Stakeholders Participation 10.3 Critical Analyses Annex A – Legislation X Regulation X Standardization Annex B – The Conformity Assessment Procedure Choice Annex C – Impact Assessment, Considerations and Examples Annex D – Risk Analyses, Method Example Annex E – Inspection and other Market Surveillance Practices Brazilian Guide on Good Regulatory Practices - Relevant Topics -

InmetroMinistry of Development Brazilian Government Requisitos Internacionais The Brazilian Guide on Good Regulatory Practices - Dissemination and Implementation Plan - - High level Meetings: The CBR Chairman relationship with Regulatory Agencies authorities; - Guide publication, in Portuguese, Spanish and English; - Folder publication; - Material for dissemination actions: folder, presentation (slides set) and the Brazilian Guide; - Research form; - Workshop for the regulatory agencies staff; - Capacity building activities;

InmetroMinistry of Development Brazilian Government Contact information: Rua Santa Alexandrina, 416 Rio Comprido - Rio de Janeiro - RJ - Brasil Cep.: Phones: + 55 (21) / + 55 (21) Consumer Center Phone: (Free of charge) Pergunte ao Inmetro -