資產可視化:歐洲製藥行業跟蹤和追溯法規
市場調查報告書
商品編碼
1057844

資產可視化:歐洲製藥行業跟蹤和追溯法規

Asset Visibility: Pharma Industry Track and Trace Regulations in Europe

出版日期: | 出版商: ABI Research | 英文 | 商品交期: 最快1-2個工作天內

價格
簡介目錄

本報告側重於資產可視化,調查歐洲製藥行業的卡車和追蹤法規,並提供有關監管環境、合規性、卡車和追蹤供應商、合格物品等方面的信息。

本報告回答的主要問題

  • 系列化法規實施時間表
  • 關鍵數據標準和可追溯性義務
  • 在各國法規中使用 GS1 等國際標準

調查重點

  • 以歐洲為重點的區域調查(歐盟、英國、瑞士、俄羅斯)
  • 歐盟法規與其他歐洲地區的差異
  • 不同級別追溯對比分析

目錄

  • 執行摘要
  • 全球監管環境
  • 區域監管環境
  • 主要用途
  • 國內法規和國際標準
  • 提案系統概述
  • 合規:義務和自願的最佳做法
  • 報告要求
  • 供應商/3PL 負責卡車和追蹤
  • 產品分銷實踐
  • 處罰/罰款
  • 實施規模和範圍
  • Track & Trace 目標項目
  • 未來的修正
  • 監管時間表
  • 序列化數據表
  • 定義和縮寫
簡介目錄
Product Code: PT-2570

Actionable Benefits:

  • Strategic planning for pharmaceutical vendors and distributors for changes in serialization regulations.
  • Gain insight into scale and scope of regulations.
  • Guidance into proposed future regulatory changes.

Critical Questions Answered:

  • What is the timeline for implementation of serialization regulations?
  • What are the key data standards and mandates for traceability?
  • How are international standards like GS1 leveraged in national regulations?

Research Highlights:

  • Regional focus on Europe (EU, UK, Switzerland & Russia)
  • Identifies variation between European Union regulations and other European regions.
  • Comparison and analysis of different levels of traceability.

Who Should Read This?

  • Strategy planners and advisors within the pharmaceutical and supporting logistics industry.
  • Managers aiming to identify regulatory requirements of their operations.
  • For serialization software and hardware providers to assess regulatory impact on the pharmaceutical market.

Table of Contents

  • Executive Summary
  • Global Regulatory Environment
  • Regional Regulatory Environment
  • Key Objectives
  • National Regulations and International Standards
  • Summary of Proposed System
  • Compliance: Mandates versus Voluntary Best Practices
  • Reporting Requirements
  • Suppliers/3PLs Responsible for Track & Trace
  • Good Distribution Practices
  • Penalties/Fines
  • Scale and Scope of Implementations
  • Items Subject to Track & Trace
  • Future Amendments Proposed
  • Regulatory Timeline
  • Serialization Data Tables
  • Definitions and Abbreviations