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Table of Contents
Intro
1. INTRODUCTION
1.1. Background
1.2. Objective
1.3. Scope
1.4. Structure
2. THE SYSTEM OF REGULATORY CONTROL
2.1. Objective
2.2. Graded approach
2.3. Special circumstances
2.4. Notification and authorization
2.5. Inspection
2.6. Enforcement
2.7. Managing transitions in regulatory control
3. MANAGEMENT AND ORGANIZATION
3.1. Integrated management system
3.2. Structure of the regulatory body
3.3. Coordination among multiple regulatory bodies and other authorities
3.4. Resource management
3.5. Safety and security culture
3.6. Management of notification and authorization
3.7. Management of inspection
3.8. Management of enforcement
3.9. Independence of the regulatory body
3.10. Human resources
3.11. Guidance and procedures
3.12. Information management system
3.13. Access to external expertise, including legal support
3.13.1. Advisory committees
3.13.2. Legal support
3.13.3. External experts and technical support organizations
4. NOTIFICATION AND AUTHORIZATION PROCESS
4.1. Introduction
4.2. Notification
4.3. Authorization
4.3.1. Application for authorization
4.3.2. Safety-security interface
4.3.3. Receipt, review and assessment of the application
4.3.4. Verification activities as part of the authorization process
4.3.5. Decision making including limits, conditions and controls
4.3.6. Records of decision and decision making process
4.3.7. Issuing or refusing the authorization and provisions for appeals
4.3.8. Subsequent regulatory actions on authorizations
5. INSPECTION PROCESS
5.1. Introduction
5.2. Types of inspection
5.3. Inspection programmes and plans
5.4. Preparation for an inspection
5.5. Entrance briefing
5.6. Conduct of inspection
5.6.1. Methods of inspection.
5.6.2. Security aspects of an inspection
5.6.3. Evidence collection
5.7. Exit briefing
5.8. Inspection reports
5.9. Post‑inspection activities
6. ENFORCEMENT PROCESS
6.1. Introduction
6.2. Overview of the enforcement process
6.3. Identification of violations or non‑compliances
6.4. Assessment of violations or non‑compliances
6.4.1. Information gathering
6.4.2. Determining the gravity of violations
6.5. Selection of enforcement actions
6.5.1. Types of available enforcement action
6.5.2. Enforcement decisions
6.6. Participation in the enforcement process
6.7. Managing evidence
REFERENCES
Annex I EXAMPLE OF NOTIFICATION FORM
Annex II CONTENT OF APPLICATION FORMS FOR AUTHORIZATION
Annex III EXAMPLE OF GUIDANCE ON THE REVIEW AND ASSESMENT OF APPLICATIONS FOR AUTHORIZATION
Annex IVEXAMPLE OF CERTIFICATE FORM FOR AUTHORIZATION
Annex VEXAMPLE OF GUIDANCE ON REGULATORY INSPECTIONS
Annex VIEXAMPLE OF A CODE OF CONDUCT FOR INSPECTORS
Annex VIIEXAMPLE OF A MEMORANDUM OF UNDERSTANDING BETWEEN THE REGULATORY BODY AND THE DEPARTMENT OF CUSTOMS
Supplement A
Supplement B
CONTRIBUTORS TO DRAFTING AND REVIEW.
1. INTRODUCTION
1.1. Background
1.2. Objective
1.3. Scope
1.4. Structure
2. THE SYSTEM OF REGULATORY CONTROL
2.1. Objective
2.2. Graded approach
2.3. Special circumstances
2.4. Notification and authorization
2.5. Inspection
2.6. Enforcement
2.7. Managing transitions in regulatory control
3. MANAGEMENT AND ORGANIZATION
3.1. Integrated management system
3.2. Structure of the regulatory body
3.3. Coordination among multiple regulatory bodies and other authorities
3.4. Resource management
3.5. Safety and security culture
3.6. Management of notification and authorization
3.7. Management of inspection
3.8. Management of enforcement
3.9. Independence of the regulatory body
3.10. Human resources
3.11. Guidance and procedures
3.12. Information management system
3.13. Access to external expertise, including legal support
3.13.1. Advisory committees
3.13.2. Legal support
3.13.3. External experts and technical support organizations
4. NOTIFICATION AND AUTHORIZATION PROCESS
4.1. Introduction
4.2. Notification
4.3. Authorization
4.3.1. Application for authorization
4.3.2. Safety-security interface
4.3.3. Receipt, review and assessment of the application
4.3.4. Verification activities as part of the authorization process
4.3.5. Decision making including limits, conditions and controls
4.3.6. Records of decision and decision making process
4.3.7. Issuing or refusing the authorization and provisions for appeals
4.3.8. Subsequent regulatory actions on authorizations
5. INSPECTION PROCESS
5.1. Introduction
5.2. Types of inspection
5.3. Inspection programmes and plans
5.4. Preparation for an inspection
5.5. Entrance briefing
5.6. Conduct of inspection
5.6.1. Methods of inspection.
5.6.2. Security aspects of an inspection
5.6.3. Evidence collection
5.7. Exit briefing
5.8. Inspection reports
5.9. Post‑inspection activities
6. ENFORCEMENT PROCESS
6.1. Introduction
6.2. Overview of the enforcement process
6.3. Identification of violations or non‑compliances
6.4. Assessment of violations or non‑compliances
6.4.1. Information gathering
6.4.2. Determining the gravity of violations
6.5. Selection of enforcement actions
6.5.1. Types of available enforcement action
6.5.2. Enforcement decisions
6.6. Participation in the enforcement process
6.7. Managing evidence
REFERENCES
Annex I EXAMPLE OF NOTIFICATION FORM
Annex II CONTENT OF APPLICATION FORMS FOR AUTHORIZATION
Annex III EXAMPLE OF GUIDANCE ON THE REVIEW AND ASSESMENT OF APPLICATIONS FOR AUTHORIZATION
Annex IVEXAMPLE OF CERTIFICATE FORM FOR AUTHORIZATION
Annex VEXAMPLE OF GUIDANCE ON REGULATORY INSPECTIONS
Annex VIEXAMPLE OF A CODE OF CONDUCT FOR INSPECTORS
Annex VIIEXAMPLE OF A MEMORANDUM OF UNDERSTANDING BETWEEN THE REGULATORY BODY AND THE DEPARTMENT OF CUSTOMS
Supplement A
Supplement B
CONTRIBUTORS TO DRAFTING AND REVIEW.